Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)
- Conditions
- Nonalcoholic Fatty Liver DiseaseNonalcoholic Steatohepatitis With Liver Fibrosis
- Interventions
- Registration Number
- NCT04321031
- Lead Sponsor
- Pfizer
- Brief Summary
The study aims to evaluate two, orally administered, investigational agents - PF-06865571 (DGAT2 inhibitor) and the coadministration of PF-06865571 with PF-05221304 (ACC inhibitor). This study is specifically designed to evaluate the effect of a range of doses of DGAT2i alone, and DGAT2i + ACCi, on resolution of NASH or improvement in liver fibrosis, as assessed histologically (via liver biopsy).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 256
- Biopsy proven NASH with either F2 or F3 fibrosis, per NASH CRN definition
- BMI >/= 22.5kg/m2
- Evidence of other causes of liver disease such as Alcoholic steatohepatitis, (de)compensated cirrhosis, active viral hepatitis
- Any condition possibly affecting drug absorption -Unstable concomitant medical conditions, based on medical history or screening laboratory results including-
- unstable liver function tests, recent cardiovascular event(s) significant malignancies,
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PF-06865571 75 mg BID PF-06865571 participants will receive medication for 48 weeks PF-06865571 150 mg BID PF-06865571 participants will receive medication for 48 weeks Placebo Placebo participants will receive medication for 48 weeks PF-06865571 25 milligrams (mg) twice daily (BID) PF-06865571 participants will receive medication for 48 weeks PF-06865571 300 mg BID PF-06865571 participants will receive medication for 48 weeks PF-06865571 (150 mg BID) + PF-05221304 (5 mg BID) PF-06865571 participants will receive medication for 48 weeks PF-06865771 (300 mg BID) + PF-05221304 (10 mg BID) PF-06865571 participants will receive medication for 48 weeks PF-06865571 (150 mg BID) + PF-05221304 (5 mg BID) PF-05221304 participants will receive medication for 48 weeks PF-06865771 (300 mg BID) + PF-05221304 (10 mg BID) PF-05221304 participants will receive medication for 48 weeks
- Primary Outcome Measures
Name Time Method Mean Proportion of Participants Achieving Resolution of NASH Without Worsening/Improvement of Fibrosis by >=1 Stage Without Worsening of NASH/Both Based on Assessment by Sponsor-Identified Central Pathologist at Week 48:Bayesian Dose Response Model (BDRM) Week 48 NASH resolution: disappearance of ballooning (Nonalcoholic Fatty Liver Disease \[NAFLD\] Activity Score \[NAS\] ballooning score=0;0=no ballooning,1=few balloon cells,2=many cells with prominent ballooning; higher scores(HS)=more disease activity \[DA\]),residual/no lobular inflammation(NAS lobular inflammation score 0/1,0=no foci,1= \<2 foci, 2=2-4 foci,3= \>4 foci; HS=more DA),NAS steatosis score 0,1,2,3; 0= \<5% hepatocytes involved (HI),1=5-33% HI ,2= 34-66% HI, 3= \>66% HI; HS=more DA. No worsening of fibrosis: no change/decrease of at least 1 stage in Brunt-Kleiner scale (BKS) compared to baseline (CTB). Improvement in fibrosis by \>=1 stage: decrease of at least 1 stage in BKS CTB. No worsening of NASH: no change/increase in NAS for ballooning, inflammation, steatosis CTB. BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (\& 90% credible interval \[CI\], indicated as 'confidence interval' below) for placebo and each BID dose studied.
Number of Participants Achieving Resolution of NASH Without Worsening or Improvement in Fibrosis by >= 1 Stage Without Worsening of NASH or Both Based on Assessment by Sponsor-Identified Central Pathologist at Week 48: Logistic Regression Model Week 48 Resolution of NASH: disappearance of ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), residual or no lobular inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= \<2 foci, 2= 2-4 foci, 3= \>4 foci; higher scores= more disease activity), NAS steatosis score 0, 1, 2, or 3, where 0= \<5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= \>66% hepatocytes involved; higher scores= more disease activity. No worsening of fibrosis: no change or decrease of at least 1 stage in BKS compared to baseline. Improvement in fibrosis by \>=1 stage: decrease of at least 1 stage in BKS compared to baseline. No worsening of NASH: no change or increase in NAS for ballooning, inflammation, steatosis compared to baseline.
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline in Liver Fat at Week 48: Bayesian Dose Response Model Baseline, Week 48 Magnetic resonance imaging proton density fat fraction (MRI-PDFF) is an established method that enables quantification of fat content in the liver.
Percent Change From Baseline in Liver Fat at Week 48: Pairwise Comparisons With Analysis of Covariance (ANCOVA) Baseline, Week 48 MRI-PDFF is an established method that enables quantification of fat content in the liver.
Mean Proportion of Participants Achieving Resolution of NASH, Without Worsening of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model Week 48 Resolution of NASH: disappearance of ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), residual or no lobular inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= \<2 foci, 2= 2-4 foci, 3= \>4 foci; higher scores= more disease activity), NAS steatosis score 0, 1, 2 or 3, where 0= \<5% HI, 1= 5-33% HI, 2= 34-66% HI, 3= \>66% HI; higher scores= more disease activity. No worsening of fibrosis: no change or decrease of at least 1 stage in BKS compared to baseline. BKS: scaling for fibrosis (0= none, 1= perisinusoidal/ periportal, 2= perisinusoidal, portal/ periportal, 3= bridging, 4= cirrhosis; higher scores= more disease activity). BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (\& 90% credible interval \[CI\], indicated as 'confidence interval' below) for placebo and each BID dose studied.
Number of Participants Achieving Resolution of NASH, Without Worsening of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model Week 48 Resolution of NASH: disappearance of ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), residual or no lobular inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= \<2 foci, 2= 2-4 foci, 3= \>4 foci; higher scores= more disease activity), NAS steatosis score 0, 1, 2 or 3, where 0= \<5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= \>66% hepatocytes involved; higher scores= more disease activity. No worsening of fibrosis: no change or decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. Brunt-Kleiner scale included scaling for fibrosis (0= none, 1= perisinusoidal/ periportal, 2= perisinusoidal, portal/ periportal, 3= bridging, 4= cirrhosis; higher scores = more disease activity). Logistic Regression model included treatment and baseline fibrosis stage (F2/F3) as factors.
Mean Proportion of Participants Achieving Improvement in Fibrosis by >=1 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model Week 48 Improvement in fibrosis by \>=1 stage: decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. No worsening of fibrosis: no change or decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. Brunt-Kleiner scale included scaling for fibrosis (0= none, 1= perisinusoidal/ periportal, 2= perisinusoidal, portal/ periportal, 3= bridging, 4= cirrhosis; higher scores = more disease activity). BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (\& 90% credible interval \[CI\], indicated as 'confidence interval' below) for placebo and each BID dose studied.
Number of Participants Achieving Improvement in Fibrosis by >=1 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model Week 48 Improvement in fibrosis by \>=1 stage: decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. No worsening of fibrosis: no change/decrease of at least 1 stage in Brunt-Kleiner scale compared to baseline. Brunt-Kleiner scale included scaling for fibrosis (0= none, 1= perisinusoidal/ periportal, 2= perisinusoidal, portal/ periportal, 3= bridging, 4= cirrhosis; higher scores = more DA). Logistic Regression model included treatment and baseline fibrosis stage (F2/F3) as factors.
Mean Proportion of Participants Achieving Improvement in Fibrosis by >=2 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model Week 48 Improvement in fibrosis by \>=2 stage: decrease of at least 2 points in total NAS compared to baseline, without progression of fibrosis. No worsening of NASH: no change or no increase in NAS for ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= \<2 foci, 2= 2-4 foci, 3= \>4 foci; higher scores= more disease activity), steatosis (NAS steatosis score 0, 1, 2, or 3, where 0= \<5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= \>66% hepatocytes involved; higher scores=more disease activity) compared to baseline. BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (\& 90% credible interval \[CI\], indicated as 'confidence interval' below) for placebo and each BID dose studied.
Number of Participants Achieving Improvement in Fibrosis by >=2 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model Week 48 Improvement in fibrosis by \>=2 stage: decrease of at least 2 points in total NAS compared to baseline, without progression of fibrosis. No worsening of NASH: no change or no increase in NAS for ballooning (NAS ballooning score= 0; where 0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity), inflammation (NAS lobular inflammation score 0 or 1, where 0= no foci, 1= \<2 foci, 2= 2-4 foci, 3= \>4 foci; higher scores= more disease activity), steatosis (NAS steatosis score 0, 1, 2 or 3, where 0= \<5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= \>66% hepatocytes involved; higher scores= more disease activity) compared to baseline. Logistic Regression model included treatment and baseline fibrosis stage (F2/F3) as factors.
Mean Proportion of Participants Achieving Improvement of >=2 Points in Total NAS, Without Progression of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model Week 48 Improvement of \>=2 points in Total NAS: decrease of at least 2 points in Total NAS compared to baseline, without progression of fibrosis. Total NAS ranged 0 to 8, higher scores= more disease activity and calculated as sum of scores of steatosis (0= \<5% hepatocytes involved, 1=5-33% hepatocytes involved, 2=34-66% hepatocytes involved, 3= \>66% hepatocytes involved; higher scores= more disease activity), lobular inflammation (0= no foci, 1= \<2 foci, 2= 2-4 foci, 3= \>4 foci; higher scores= more disease activity), ballooning (0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more disease activity). If sub-scale scores non evaluable or missing, total score was derived as missing. BDRM utilized to characterize dose response across BID treatment groups, estimate posterior mean proportion (\& 90% credible interval \[CI\], indicated as 'confidence interval' below) for placebo and each BID dose studied.
Number of Participants Achieving Improvement of >=2 Points in Total NAS Without Progression of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model Week 48 Improvement of \>=2 points in Total NAS: decrease of at least 2 points in Total NAS compared to baseline, without progression of fibrosis. Total NAS ranged from 0 to 8, higher scores= more DA and calculated as sum of scores of steatosis (0= \<5% hepatocytes involved, 1= 5-33% hepatocytes involved, 2= 34-66% hepatocytes involved, 3= \>66% hepatocytes involved; higher scores= more DA), lobular inflammation (0= no foci, 1= \<2 foci, 2= 2-4 foci, 3= \>4 foci; higher scores= more DA), ballooning (0= no ballooning, 1= few balloon cells, 2= many cells with prominent ballooning; higher scores= more DA). If any of the sub-scale scores were non evaluable/missing, then the total score was derived as missing. Logistic Regression model included treatment and baseline fibrosis stage (F2/F3) as factors.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks) An adverse event (AE) was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Serious adverse events (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life threatening (risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. AEs included both serious and all non-serious AEs. TEAEs were defined as newly occurring or worsening AE after the first dose of study drug.
Number of Participants With Laboratory Test Abnormalities From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks) Laboratory abnormalities included: Hematology (Hemoglobin \[hgb\], hematocrit, erythrocytes \[ery\]: \<0.8\*lower limit of normal \[LLN\]; reticulocytes, reticulocytes/ery: \<0.5\*LLN, \>1.5\*upper LN \[ULN\]; ery mean corpuscular volume \[EMC\], EMC hgb: \<0.9\*LLN, \>1.1\*ULN; platelet: \>1.75 ULN; lymphocytes, neutrophils, basophils, eosinophils: \<0.8\* LLN, \>1.2\*ULN; monocytes: \>1.2\*ULN; activated partial thromboplastin time, prothrombin time: \>1.1\*ULN); Clinical chemistry (Total/direct bilirubin, glucose:\>1.5\*ULN; aspartate aminotransferase \[AT\], alanine AT, gamma glutamyl transferase: \>3.0\*ULN; HDL cholesterol: \<0.8\*LLN; urea nitrogen, creatinine, triglyceride, cholesterol, hgb A1C: \>1.3\*ULN; urate: \>1.2\*ULN; potassium: \<0.9\*LLN, \>1.1\*ULN; sodium: \<0.95\*LLN; calcium, bicarbonate: \<0.9\*LLN; creatine kinase: \>2.0\*ULN); Urinalysis (glucose, protein, hgb, ketones, nitrite, leukocyte esterase, urobilinogen, bilirubin: \>=1; ery, leukocytes: \>=20; granular, hyaline casts: \>1).
Number of Participants With Clinically Significant Abnormalities in Vital Signs From first dose of study drug (Day 1) upto Week 48 (maximum up to approximately 50 weeks) Number of participants with clinically significant vital signs were reported in this outcome measure. Vital signs included blood pressure, and heart rate. Clinical significance in vital signs abnormalities was judged by investigator.
Number of Participants With Clinically Significant Abnormalities in Electrocardiograms (ECG) Parameters From first dose of study drug (Day 1) upto Week 48 (maximum up to approximately 50 weeks) Number of participants with clinically significant ECG abnormalities were reported in this outcome measure. ECG parameters included heart rate, PR interval, QRS interval and QTcF interval.
Trial Locations
- Locations (286)
Mayo Clinic Florida
🇺🇸Jacksonville, Florida, United States
United Medical Doctors
🇺🇸Murrieta, California, United States
DCC Mladost-M Varna OOD
🇧🇬Varna, Bulgaria
Institute for Liver Health dba Arizona Liver Health
🇺🇸Chandler, Arizona, United States
Comprehensive Interventional Care Centers (CICC)
🇺🇸Sun City, Arizona, United States
The Institute for Liver Health
🇺🇸Peoria, Arizona, United States
Institute for Liver Health DBA Arizona Liver Health
🇺🇸Tucson, Arizona, United States
Hope Clinical Research
🇺🇸Canoga Park, California, United States
Sharp Coronado Hospital
🇺🇸Coronado, California, United States
Southern California Research Center
🇺🇸Coronado, California, United States
Magnolia Surgery Center
🇺🇸El Cajon, California, United States
Encino Hospital Medical Center
🇺🇸Encino, California, United States
National Research Institute
🇺🇸Huntington Park, California, United States
Investigational Drug Service, Altman Clinical and Translational Research Institute (ACTRI)
🇺🇸La Jolla, California, United States
University of California San Diego, Altman Clinical and Translational Research Institute Clinic
🇺🇸La Jolla, California, United States
UCSD Altman Clinical and Transitional Research Institute
🇺🇸La Jolla, California, United States
A V Pediatrics, Allergy & Family Medicine
🇺🇸Lancaster, California, United States
Jatinder S. Pruthi, M.D. FACG CPI
🇺🇸Lancaster, California, United States
Om Research LLC
🇺🇸Lancaster, California, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Cedars-Sinai Advanced Health Sciences Pavilion (Imaging)
🇺🇸Los Angeles, California, United States
Cedars-Sinai Comprehensive Transplant Center
🇺🇸Los Angeles, California, United States
Cedars-Sinai Medical Center Investigational Drug Services (Pharmacy)
🇺🇸Los Angeles, California, United States
S. Mark Taper Foundation Imaging Center (Liver Biopsy)
🇺🇸Los Angeles, California, United States
Providence Facey Medical Foundation
🇺🇸Mission Hills, California, United States
Providence Holy Cross Medical Center
🇺🇸Mission Hills, California, United States
ART Vascular
🇺🇸Montebello, California, United States
MC Leo Clinic EOOD
🇧🇬Varna, Bulgaria
Back Bay Imaging (Liver Biopsy)
🇺🇸Newport Beach, California, United States
Advanced Imaging Center
🇺🇸Palmdale, California, United States
Blake Wilbur Outpatient Clinic (MRI)
🇺🇸Palo Alto, California, United States
Stanford Hospital and Clinics
🇺🇸Palo Alto, California, United States
California Liver Research Institute
🇺🇸Pasadena, California, United States
HMRI
🇺🇸Pasadena, California, United States
Stanford Medicine Outpatient Center (Liver clinic/MRI)
🇺🇸Redwood City, California, United States
Inland Empire Clinical Trials, LLC
🇺🇸Rialto, California, United States
Clinical Trials Research
🇺🇸Sacramento, California, United States
Precision Research Institute
🇺🇸San Diego, California, United States
WR-MCCR
🇺🇸San Diego, California, United States
Sharp and Children's MRI Center, LLC
🇺🇸San Diego, California, United States
Stanford Cancer Center South Bay (MRI)
🇺🇸San Jose, California, United States
Liberty Pacific Advanced Imaging
🇺🇸Tarzana, California, United States
Orange County Research Center
🇺🇸Tustin, California, United States
Upland Clinical Research
🇺🇸Upland, California, United States
Bristol Hospital
🇺🇸Bristol, Connecticut, United States
Bristol Radiology Center
🇺🇸Bristol, Connecticut, United States
Connecticut Clinical Research Institute, LLC
🇺🇸Bristol, Connecticut, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Yale New Haven Hospital, Saint Raphael Campus (MRE location)
🇺🇸New Haven, Connecticut, United States
Yale Center for Clinical Investigators, Church Street South Research Unit (CSRU)
🇺🇸New Haven, Connecticut, United States
Yale Digestive Diseases (Fibroscan location)
🇺🇸New Haven, Connecticut, United States
Tower Radiology (MRI-PDFF)
🇺🇸Brandon, Florida, United States
Tower Radiology - Parsons
🇺🇸Brandon, Florida, United States
Gastro Florida
🇺🇸Clearwater, Florida, United States
Integrity Clinical Research, LLC
🇺🇸Doral, Florida, United States
Florida Research Institute
🇺🇸Lakewood Ranch, Florida, United States
Center for Advanced Gastroenterology
🇺🇸Maitland, Florida, United States
Sandlake Imaging
🇺🇸Maitland, Florida, United States
San Marcus Research Clinic, Inc.
🇺🇸Miami Lakes, Florida, United States
Optimus U Corporation
🇺🇸Miami, Florida, United States
Unique Imaging (Biscayne Imaging Center)
🇺🇸Miami, Florida, United States
Acevedo Clinical Research Associates
🇺🇸Miami, Florida, United States
Ivetmar Medical Group LLC
🇺🇸Miami, Florida, United States
Vascular and Interventional Specialists of Florida (Liver Biopsy)
🇺🇸Miami, Florida, United States
Care Research Center Inc
🇺🇸Miami, Florida, United States
TGH Imaging Powered by Tower Radiology Center (MRI)
🇺🇸Oldsmar, Florida, United States
Clinical Neuroscience Solutions, Inc
🇺🇸Orlando, Florida, United States
Omega Research Maitland, LLC
🇺🇸Orlando, Florida, United States
Innovation Medical Research Center, Inc
🇺🇸Palmetto Bay, Florida, United States
GCP, Global Clinical Professionals
🇺🇸Saint Petersburg, Florida, United States
Gateway (Ultrasound)
🇺🇸Saint Petersburg, Florida, United States
Partners Imaging Center
🇺🇸Sarasota, Florida, United States
Radiology Associates
🇺🇸Tampa, Florida, United States
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
AdventHealth Zephyrhills
🇺🇸Zephyrhills, Florida, United States
Florida Medical Clinic, LLC
🇺🇸Zephyrhills, Florida, United States
Digestive Healthcare of Georgia
🇺🇸Atlanta, Georgia, United States
Piedmont Atlanta Hospital/Piedmont Transplant Institute
🇺🇸Atlanta, Georgia, United States
Piedmont Atlanta Hospital
🇺🇸Atlanta, Georgia, United States
Columbus Regional Research Institute
🇺🇸Columbus, Georgia, United States
WR-Mount Vernon Clinical Research, LLC
🇺🇸Sandy Springs, Georgia, United States
Tekton Research, Inc.
🇺🇸Snellville, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Investigators Research Group, LLC
🇺🇸Brownsburg, Indiana, United States
Hendricks Regional Health
🇺🇸Hendricks, Indiana, United States
Heartland Medical Research, Inc. (Administrative Only)
🇺🇸Clive, Iowa, United States
Iowa Digestive Disease Center
🇺🇸Clive, Iowa, United States
Iowa Radiology
🇺🇸Clive, Iowa, United States
MercyOne Des Moines Medical Center (Mercy Medical Center)
🇺🇸Des Moines, Iowa, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
University of Iowa Magnetic Resonance Research Facility
🇺🇸Iowa City, Iowa, United States
Kansas Medical Clinic PA
🇺🇸Topeka, Kansas, United States
Alliance for Multispecialty Research, LLC
🇺🇸Wichita, Kansas, United States
Cypress Interventional
🇺🇸Wichita, Kansas, United States
Centex Studies, Inc.
🇺🇸Houston, Texas, United States
Lake Charles Memorial Hospital
🇺🇸Lake Charles, Louisiana, United States
Metropolitan Gastroenterology Associates
🇺🇸Marrero, Louisiana, United States
Tandem Clinical Research GI, LLC
🇺🇸Marrero, Louisiana, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Louisiana Research Center, LLC
🇺🇸Shreveport, Louisiana, United States
Gastro Health Research
🇺🇸Fairfax, Virginia, United States
Gastro Center of Maryland
🇺🇸Columbia, Maryland, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Michigan Clinical Research Unit (MCRU)
🇺🇸Ann Arbor, Michigan, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Aa Mrc Llc
🇺🇸Flint, Michigan, United States
Mercy Health
🇺🇸Grand Rapids, Michigan, United States
M1 Imaging Center
🇺🇸Grand Rapids, Michigan, United States
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
🇺🇸Wyoming, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Jefferson City Medical Group, P.C.
🇺🇸Jefferson City, Missouri, United States
Desert Radiology
🇺🇸Las Vegas, Nevada, United States
Machuca Family Medicine
🇺🇸Las Vegas, Nevada, United States
The Machuca Foundation, Inc.
🇺🇸Las Vegas, Nevada, United States
Sierra Clinical Research
🇺🇸Las Vegas, Nevada, United States
Las Vegas Medical Research
🇺🇸Las Vegas, Nevada, United States
Pueblo Medical Imaging
🇺🇸Las Vegas, Nevada, United States
Digestive Healthcare Associates
🇺🇸Hillsborough, New Jersey, United States
University Radiology
🇺🇸Hillsborough, New Jersey, United States
Amici Clinical Research
🇺🇸Raritan, New Jersey, United States
Northwell Health Center for Liver Diseases
🇺🇸Manhasset, New York, United States
Icahn School of Medicine at Mount Sinai/The Mount Sinai Hospital
🇺🇸New York, New York, United States
M3 - Wake Research, Inc.
🇺🇸Raleigh, North Carolina, United States
Gastroenterology Associates of the Piedmont, PA
🇺🇸Winston-Salem, North Carolina, United States
Novant Health Medical Center
🇺🇸Winston-Salem, North Carolina, United States
PMG Research of Winston-Salem, LLC
🇺🇸Winston-Salem, North Carolina, United States
Paramount Medical Research & Consulting, LLC
🇺🇸Middleburg Heights, Ohio, United States
Comprehensive Diagnostic Imaging
🇺🇸Oklahoma City, Oklahoma, United States
Digestive Disease Specialists, Inc. Endoscopy Lab
🇺🇸Oklahoma City, Oklahoma, United States
Digestive Disease Specialists, Inc.
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma Spine Hospital
🇺🇸Oklahoma City, Oklahoma, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
UPMC - Center for Liver Diseases at the Thomas E. Starzl Institute
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC - Center for Liver Diseases in the Digestive Disorders Clinic
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC - Translational Research Center
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Presbyterian Shadyside; Presbyterian Campus Pharmacy
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
University Gastroenterology
🇺🇸Providence, Rhode Island, United States
Roger Williams Hospital
🇺🇸Providence, Rhode Island, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
MUSC- Ashley River Tower
🇺🇸Charleston, South Carolina, United States
Chattanooga Imaging Center
🇺🇸Chattanooga, Tennessee, United States
WR-Clinsearch, LLC
🇺🇸Chattanooga, Tennessee, United States
Quality Medical Research, PLLC
🇺🇸Nashville, Tennessee, United States
Vanderbilt Hepatology and Liver Transplant
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center - GI Research Office
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center - Digestive Disease Center
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center - Heart Station
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center - Interventional Radiology
🇺🇸Nashville, Tennessee, United States
Texas Center for Interventional Surgery (Liver Biopsy Facility)
🇺🇸Addison, Texas, United States
Texas Clinical Research Institute
🇺🇸Arlington, Texas, United States
Methodist Dallas Medical Center (MRI-PDFF)
🇺🇸Dallas, Texas, United States
The Liver Institute at Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States
Touchstone Imaging
🇺🇸Dallas, Texas, United States
Center For Diagnostic Imaging
🇺🇸DeSoto, Texas, United States
GI Alliance
🇺🇸Fort Worth, Texas, United States
Therapeutic Concepts, PA
🇺🇸Houston, Texas, United States
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
Premier Vein and Vascular
🇺🇸Houston, Texas, United States
Centex Studies, Inc
🇺🇸McAllen, Texas, United States
HCA Houston Healthcare Pearland
🇺🇸Pearland, Texas, United States
American Research Corporation at the Texas Liver Institute
🇺🇸San Antonio, Texas, United States
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States
Diabetes and Glandular Disease Clinic, P.A.
🇺🇸San Antonio, Texas, United States
Reddy Cardiac Wellness
🇺🇸Sugar Land, Texas, United States
Impact Research Institute
🇺🇸Waco, Texas, United States
Gastro Health, LLC
🇺🇸Fairfax, Virginia, United States
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, United States
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
Sentara Leigh Hospital
🇺🇸Norfolk, Virginia, United States
McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
VCU Medical Center Investigational Drug Service
🇺🇸Richmond, Virginia, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Virginia Gastroenterology Clinical Research
🇺🇸Suffolk, Virginia, United States
Harborview Medical Center Investigational Drug Services
🇺🇸Seattle, Washington, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Seattle Radiology
🇺🇸Seattle, Washington, United States
Liver Institute Northwest
🇺🇸Seattle, Washington, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
MHAT Dr. Tota Venkova AD
🇧🇬Gabrovo, Bulgaria
MHAT Medline Clinic AD
🇧🇬Plovdiv, Bulgaria
Acibadem City Clinic MHAT Tokuda EAD
🇧🇬Sofia, Bulgaria
DCC Alexandrovska EOOD
🇧🇬Sofia, Bulgaria
UMHAT Sv. Ivan Rilski EAD
🇧🇬Sofia, Bulgaria
UMHAT Sofiamed OOD
🇧🇬Sofia, Bulgaria
MC New Rehabilitation Center EOOD
🇧🇬Stara Zagora, Bulgaria
University of Calgary - Heritage Medical Research Clinic (HMRC)
🇨🇦Calgary, Alberta, Canada
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Gordon and Leslie Diamond Health Care Centre
🇨🇦Vancouver, British Columbia, Canada
(G.I.R.I.) GI Research Institute
🇨🇦Vancouver, British Columbia, Canada
Nova Scotia Health Authority QEII (Queen Elizabeth II) Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
Manna Research (London)
🇨🇦London, Ontario, Canada
Toronto Liver Centre
🇨🇦Toronto, Ontario, Canada
Resonance Magnetique du Saguenay-Lac-Saint-Jean
🇨🇦Chicoutimi, Quebec, Canada
Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean
🇨🇦Chicoutimi, Quebec, Canada
Ecogene-21
🇨🇦Chicoutimi, Quebec, Canada
McGill University Health Centre (MUHC)
🇨🇦Montreal, Quebec, Canada
Philips Radiation Oncology
🇨🇦Montreal, Quebec, Canada
Research Institute of the MUHC
🇨🇦Montreal, Quebec, Canada
Centre de recherche du Centre hospitalier de l'Université de Montréal (CRCHUM)
🇨🇦Montréal, Quebec, Canada
Diex Recherche Quebec Inc.
🇨🇦Quebec, Canada
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The Third Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Hunan Provincial People's Hospital
🇨🇳Changsha, Hunan, China
The First Bethune Hospital of Jilin University
🇨🇳Changchun, Jilin, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Qingdao Central Hospital
🇨🇳Qingdao, Shandong, China
The Affiliated Hospital of Hangzhou Normal University
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Peking University People's Hospital
🇨🇳Beijing, China
Beijing YouAn Hosptial,Capital Medical University
🇨🇳Beijing, China
Beijing Tsinghua Changgung Hospital
🇨🇳Beijing, China
Tianjin Third Central Hospital
🇨🇳Tianjin, China
Tianjin Second People's Hospital
🇨🇳Tianjin, China
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Prince of Wales Hospital
🇭🇰Shatin, Hong Kong
Alice Ho Miu Ling Nethersole Hospital
🇭🇰Tai Po, Hong Kong
Surat Institute of Digestive Sciences
🇮🇳Surat, Gujarat, India
Gujarat Hospital - Gastro and Vascular Centre
🇮🇳Surat, Gujarat, India
Global Hospital - Super Speciality & Transplant Centre
🇮🇳Mumbai, Maharashtra, India
Max Smart Super Speciality Hospital
🇮🇳Saket, NEW Delhi, India
S.M.S. Medical College & Hospital
🇮🇳Jaipur, Rajasthan, India
Institute of Post Graduate Medical Education and Research & SSKM Hospital
🇮🇳Kolkata, WEST Bengal, India
Medanta - The Medicity
🇮🇳Gurugram, India
Institute of Liver and Biliary Sciences (ILBS)
🇮🇳New Delhi, India
All India Institute of Medical Sciences (AIIMS)
🇮🇳New Delhi, India
Aichi Medical University Hospital
🇯🇵Nagakute, Aichi, Japan
Ehime University Hospital
🇯🇵Toon, Ehime, Japan
Ogaki Municipal Hospital
🇯🇵Ogaki, Gifu, Japan
Tokyo Medical University Ibaraki Medical Center
🇯🇵Inashiki-gun, Ibaraki, Japan
Kagawa Prefectural Central Hospital
🇯🇵Takamatsu, Kagawa, Japan
Yokohama City University Hospital
🇯🇵Yokohama, Kanagawa, Japan
Shinshu University Hospital
🇯🇵Matsumoto, Nagano, Japan
National Hospital Organization Nagasaki Medical Center
🇯🇵Ohmura, Nagasaki, Japan
Osaka Rosai Hospital
🇯🇵Sakai, Osaka, Japan
Saiseikai Suita Hospital
🇯🇵Suita, Osaka, Japan
Juntendo University Shizuoka Hospital
🇯🇵Izunokuni, Shizuoka, Japan
Chiba University Hospital
🇯🇵Chiba, Japan
Fukui-Ken Saiseikai Hospital
🇯🇵Fukui, Japan
Gifu Municipal Hospital
🇯🇵Gifu, Japan
Kagoshima University Hospital
🇯🇵Kagoshima, Japan
University Hospital, Kyoto Prefectural University of Medicine
🇯🇵Kyoto, Japan
Miyazaki Medical Center Hospital
🇯🇵Miyazaki, Japan
Saga University Hospital
🇯🇵Saga, Japan
Yamagata University Hospital
🇯🇵Yamagata, Japan
SMG-SNU Boramae Medical Center
🇰🇷Dongjak-gu, Seoul, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Yeungnam University Hospital
🇰🇷Daegu, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Szpital Zakonu Bonifratrow
🇵🇱Katowice, Poland
NZOZ Vita Longa Sp. z o.o.
🇵🇱Katowice, Poland
Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego
🇵🇱Katowice, Poland
Orthos Szpital Wielospecjalistyczny Sp. z o.o. (Liver Biopsy)
🇵🇱Komorowice, Poland
SPZOZ Szpital Uniwersytecki w Krakowie
🇵🇱Krakow, Poland
Szpital Zakonu Bonifratrów św. Jana Grandego w Krakowie sp. z o.o. (Liver Biopsy)
🇵🇱Krakow, Poland
Krakowskie Centrum Medyczne
🇵🇱Krakow, Poland
Wojewodzki Specjalistyczny Szpital im. Dr. Wl. Bieganskiego w Lodzi
🇵🇱Lodz, Poland
ID Clinic
🇵🇱Myslowice, Poland
WIP Warsaw IBD Point Profesor Kierkus
🇵🇱Warszawa, Poland
Futuremeds Sp. z o.o.
🇵🇱Wroclaw, Poland
ETG Zamosc
🇵🇱Zamosc, Poland
Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
🇵🇱Zamosc, Poland
Clinical Research Puerto Rico
🇵🇷San Juan, Puerto Rico
Latin Clinical Trial Center
🇵🇷San Juan, Puerto Rico
GCM Medical Group PSC
🇵🇷San Juan, Puerto Rico
FDI Clinical Research
🇵🇷San Juan, Puerto Rico
Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica
🇸🇰Banska Bystrica, Slovakia
SUMMIT CLINICAL RESEARCH, s.r.o.
🇸🇰Bratislava - Mestska Cast Nove Mesto, Slovakia
Lama Medical Care s.r.o.
🇸🇰Bratislava - Mestska Cast Ruzinov, Slovakia
Medispektrum, s.r.o
🇸🇰Bratislava, Slovakia
Univerzitna nemocnica L. Pasteura Kosice
🇸🇰Kosice - Mestska Cast Zapad, Slovakia
KM Management spol. s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
🇸🇰Nitra, Slovakia
Fakultna nemocnica Nitra
🇸🇰Nitra, Slovakia
JAL, s.r.o.
🇸🇰Trnava, Slovakia
Changhua Christian Hospital
🇨🇳Changhua City, Changhua County, Taiwan
Ditmanson Medical Foundation Chia-Yi Christian Hospital
🇨🇳Chia-Yi, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
National Cheng Kung University (NCKU) Hospital
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan