A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis
- Registration Number
- NCT04171765
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to placebo in participants with non-alcoholic steatohepatitis (NASH).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 46
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive a fixed dose of placebo matched to BFKB8488A. Fixed Dose: BFKB8488A Dose A BFKB8488A Participants will receive BFKB8488A. Fixed Dose: BFKB8488A Dose B BFKB8488A Participants will receive BFKB8488A. Fixed Dose: BFKB8488A Dose C BFKB8488A Participants will receive BFKB8488A.
- Primary Outcome Measures
Name Time Method Proportion of Participants With NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at Week 52 Week 52 Resolution of non-alcoholic steatohepatitis (NASH) is defined as a non-alcoholic fatty liver disease activity score (NAS) of 0-1 for inflammation, 0 for ballooning, and any value for steatosis as determined by a central reader. Worsening of fibrosis is defined as any increase in NASH Clinical Research Network (CRN) fibrosis stage as determined by a central reader.
- Secondary Outcome Measures
Name Time Method Proportion of Participants With Improvement in Liver Fibrosis of at Least One Stage, as Defined by NASH Clinical Research Network (CRN), and no Worsening of NASH at Week 52 Week 52 Change From Baseline in Hepatic Fat Fraction as Assessed by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at Week 52 Baseline, Week 16, Week 52 Proportion of Participants With Improvement in Liver Histology From Baseline and no Worsening of Fibrosis at Week 52 Week 52
Trial Locations
- Locations (53)
National Research Inst.
🇺🇸Los Angeles, California, United States
South Denver Gastroenterology
🇺🇸Englewood, Colorado, United States
Gastrointestinal Specialists of Georgia, PC
🇺🇸Marietta, Georgia, United States
Wexner Medical Center; Ohio State University; Investigational Drug Services; Pharmacy Department
🇺🇸Columbus, Ohio, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Liver Associates of Texas - Houston
🇺🇸Houston, Texas, United States
UC San Diego Airway Research and Clinical Trials Center
🇺🇸San Diego, California, United States
Hospices Civils de Lyon
🇫🇷Lyon, France
Duke Medical Center; Gen Clinic Research Ctr
🇺🇸Durham, North Carolina, United States
Clinical Trials of Texas, Inc
🇺🇸San Antonio, Texas, United States
Pinnacle Clinical Research - San Antonio
🇺🇸San Antonio, Texas, United States
Consorcio Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Cullman Clinical Trials
🇺🇸Cullman, Alabama, United States
Arizona Liver Health - Chandler
🇺🇸Chandler, Arizona, United States
Arizona Liver Health - Tucson
🇺🇸Tucson, Arizona, United States
Orange Grove Family Practice
🇺🇸Tucson, Arizona, United States
Arkansas Gastroenterology
🇺🇸North Little Rock, Arkansas, United States
Conquest Clinical Research
🇺🇸Orange, California, United States
Community Cancer Institute (CCI)
🇺🇸Fresno, California, United States
National Research Institute - Panorama City
🇺🇸Santa Monica, California, United States
Premier Research Associate, Inc
🇺🇸Miami, Florida, United States
Covenant Research
🇺🇸Sarasota, Florida, United States
Grand Teton Research Group, PLLC
🇺🇸Idaho Falls, Idaho, United States
Huron Gastroenterology Associates
🇺🇸Ypsilanti, Michigan, United States
Amici Clinical Research
🇺🇸Raritan, New Jersey, United States
Liver Institute at Renaissance
🇺🇸Edinburg, Texas, United States
Texas Digestive Disease Consultant - Ft Worth (TDDC - Ft Worth)
🇺🇸Fort Worth, Texas, United States
American Research Corporation Inc.
🇺🇸San Antonio, Texas, United States
Quality Research Inc
🇺🇸San Antonio, Texas, United States
Texas Digestive Disease Consultants - San Marcos
🇺🇸San Marcos, Texas, United States
Hospital Erasme
🇧🇪Bruxelles, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Antwerp University Hospital
🇧🇪Edegem, Belgium
CHU de Nice
🇫🇷Nice, France
CHU Hopitaux de Bordeaux
🇫🇷CHU Hopitaux De Bordeaux, France
Fundacion de Investigacion de Diego
🇵🇷San Juan, Puerto Rico
Hôpital d'Enfants, Service d?onco-hématologie pédiatrique
🇫🇷Vandoeuvre, France
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Clinico Universitario de Valencia; Servicio de Anatomia Patologica
🇪🇸Valencia, Spain
Hospital Universtiario Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Universitari i Politecnic La Fe; Servicio de Neurología
🇪🇸Valencia, Spain
Pinnacle Clinical Research - Austin
🇺🇸Austin, Texas, United States
Gregory Wiener, MD
🇺🇸Chula Vista, California, United States
Excel Medical Research
🇺🇸Boca Raton, Florida, United States
Avant Research Associates, LLC
🇺🇸Crowley, Louisiana, United States
Texas Digetive Disease Consultants - Austin
🇺🇸Cedar Park, Texas, United States
South Texas Research Institute
🇺🇸Edinburg, Texas, United States
Hopital Pitie-Salpetriere APHP
🇫🇷Paris, France
Gastroenterology Associates, LLC
🇺🇸Baton Rouge, Louisiana, United States
Walter Reed Army Medical Center
🇺🇸Bethesda, Maryland, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Hunter Holmes McGuire V.A. Medical Center
🇺🇸Richmond, Virginia, United States
Kansas City Research Institute, LLC
🇺🇸Kansas City, Missouri, United States