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
Completed · Phase 3
Conditions studied: Hepatitis C
In brief
To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects
Key facts
- Study ID
- NCT01979939
- Run by
- Bristol-Myers Squibb
- People needed
- 416
- Starts
- 2013-12-01
- Expected to finish
- 2014-11-01
- Last updated by the study team
- 2015-11-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Medical Associates Research Group — San Diego, California, United States
- Quest Clinical Research — San Francisco, California, United States
- University Of Colorado Denver & Hospital — Aurora, Colorado, United States
- Borland-Groover Clinic — Jacksonville, Florida, United States
- Orlando Immunology Center — Orlando, Florida, United States
- Miami Research Associates — South Miami, Florida, United States
- Gastrointestinal Specialists Of Georgia — Marietta, Georgia, United States
- University Of Chicago Medical Center — Chicago, Illinois, United States
- Indiana University Med Center — Indianapolis, Indiana, United States
- Digestive Disease Associates, P.A. — Catonsville, Maryland, United States
- Johns Hopkins Medical Institutions — Lutherville, Maryland, United States
- Henry Ford Health System — Novi, Michigan, United States
- Kansas City Care Clinic — Kansas City, Missouri, United States
- Kansas City Research Institute — Kansas City, Missouri, United States
- Washington University School Of Medicine — St Louis, Missouri, United States
- The Gastroenterology Group Of South Jersey — Vineland, New Jersey, United States
- Binghamton Gastroenterology Associates — Binghamton, New York, United States
- Weill Cornell Medical College — New York, New York, United States
- Premier Medical Group Of The Hudson Valley, Pc — Poughkeepsie, New York, United States
- James J Peters Vamc — The Bronx, New York, United States
- Asheville Gastroenterology Associates, Pa — Asheville, North Carolina, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Carolinas Center For Liver Disease — Statesville, North Carolina, United States
- Trial Management Associates, Llc — Wilmington, North Carolina, United States
- Scripps Clinic — La Jolla, California, United States
Full record on ClinicalTrials.gov
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