UNITY 1: A Study of an Investigational Treatment Regimen of Daclatasvir (DCV) + Asunaprevir (ASV) + BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) for 12 Weeks for the Treatment of Chronic Hepatitis C Virus (HCV) Genotype 1 Infection in Non-cirrhotic Subjects
- Conditions
- Hepatitis C
- Interventions
- Drug: DCV/ASV/BMS-791325
- Registration Number
- NCT01979939
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 416
- Subjects chronically infected with HCV genotype 1
- HCV RNA ≥ 10,000 IU/mL at screening
- Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), RBV, or HCV DAA (protease, polymerase inhibitor, etc.)
- Treatment-experienced subjects are eligible
- Evidence of cirrhosis
- Liver or any other organ transplant
- Current or known history of cancer within 5 years prior to enrollment
- Documented or suspected HCC
- Evidence of decompensated liver
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A 1: DCV/ASV/BMS-791325 in treatment-naive subjects DCV/ASV/BMS-791325 Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks A 2: DCV/ASV/BMS-791325 in treatment-experienced subjects DCV/ASV/BMS-791325 Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks
- Primary Outcome Measures
Name Time Method Proportion of treated subjects in the naive cohort with sustained virologic response (SVR) 12 Post-Treatment Week 12 SVR12 is defined as HCV ribonucleic acid (RNA) \< limit of quantitation (LOQ) target detected or target not detected (LOQ TD/TND) at post treatment Week 12
- Secondary Outcome Measures
Name Time Method Proportion of subjects in the experienced cohort with SVR12 Follow up Week 12 Proportion of subjects in each cohort who achieve HCV RNA <LOQ TD/TND On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24) Proportion of subjects in each cohort who achieve HCV RNA <LOQ TND On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment weeks 4, 8, 12 and 24 Safety measured by frequency of serious AEs (SAEs) and discontinuations due to adverse events (AEs) through the end of treatment in each cohort Up to post treatment week 4 (±7 days) Proportion of anemia defined as Hg <10 g/dL on-treatment and Hg ≥10 g/dL at baseline , in each cohort Up to post treatment week 4 (±7 days) Rates of selected grade 3-4 lab abnormalities (hematologic and liver function) in each cohort Up to post treatment week 4 (±7 days) Proportion of subjects in each cohort achieving SVR12 associated with HCV geno subtype 1a vs 1b Post treatment week 12 Proportion of subjects in each cohort achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism (SNP) status (CC genotype or non-CC genotype) Post treatment week 12 Proportion of subjects in each cohort achieving SVR12 associated with stage of liver fibrosis Post treatment week 12
Trial Locations
- Locations (44)
Carolinas Center For Liver Disease
🇺🇸Statesville, North Carolina, United States
Healthcare Research Consultants
🇺🇸Tulsa, Oklahoma, United States
Johns Hopkins Medical Institutions
🇺🇸Lutherville, Maryland, United States
James J Peters Vamc
🇺🇸Bronx, New York, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
Borland-Groover Clinic
🇺🇸Jacksonville, Florida, United States
Miami Research Associates
🇺🇸South Miami, Florida, United States
Digestive Disease Associates, P.A.
🇺🇸Catonsville, Maryland, United States
Gastrointestinal Specialists Of Georgia
🇺🇸Marietta, Georgia, United States
The Gastroenterology Group Of South Jersey
🇺🇸Vineland, New Jersey, United States
Henry Ford Health System
🇺🇸Novi, Michigan, United States
Binghamton Gastroenterology Associates
🇺🇸Binghamton, New York, United States
Trial Management Associates, Llc
🇺🇸Wilmington, North Carolina, United States
Premier Medical Group Of The Hudson Valley, Pc
🇺🇸Poughkeepsie, New York, United States
Asheville Gastroenterology Associates, Pa
🇺🇸Asheville, North Carolina, United States
Options Health Research, Llc
🇺🇸Tulsa, Oklahoma, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Mt Vernon Endoscopy Center
🇺🇸Alexandria, Virginia, United States
Bon Secours St. Mary'S Hospital Of Richmond, Inc.
🇺🇸Newport News, Virginia, United States
Local Institution
🇫🇷Vandoeuvre Les Nancy, France
Fundacion De Investigacion De Diego
🇵🇷San Juan, Puerto Rico
Washington University School Of Medicine
🇺🇸Saint Louis, Missouri, United States
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
University Gastroenterology
🇺🇸Providence, Rhode Island, United States
Digestive And Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
Dean Clinic
🇺🇸Madison, Wisconsin, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Medical Associates Research Group
🇺🇸San Diego, California, United States
Quest Clinical Research
🇺🇸San Francisco, California, United States
Kansas City Research Institute
🇺🇸Kansas City, Missouri, United States
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
University Of Colorado Denver & Hospital
🇺🇸Aurora, Colorado, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
Indiana University Med Center
🇺🇸Indianapolis, Indiana, United States
Kansas City Care Clinic
🇺🇸Kansas City, Missouri, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Digestive Health Specialists, Pa
🇺🇸Winston-salem, North Carolina, United States
Texas Liver Institute
🇺🇸San Antonio, Texas, United States
University Of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
University Of Pittsburgh Medical Center, Ctr For Liver Diseases
🇺🇸Pittsburg, Pennsylvania, United States
Baylor St. Luke'S Medical Center
🇺🇸Houston, Texas, United States
Hospital Of The University Of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Quality Medical Research Pllc
🇺🇸Nashville, Tennessee, United States