UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Hepatitis C

In brief

To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.

Key facts

Study ID

NCT01973049

Run by

Bristol-Myers Squibb

People needed

202

Starts

2013-12-01

Expected to finish

2014-11-01

Last updated by the study team

2015-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects chronically infected with HCV genotype 1
• Subjects with compensated cirrhosis
• HCV RNA ≥ 10,000 IU/mL at screening
• Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), Ribavirin (RBV), or HCV Direct Acting Antivirals (DAA) (protease, polymerase inhibitor, etc.)
• Treatment-experienced subjects are eligible including exposure to anti-HCV agents of a mechanistic class other than those contained in the Daclatasvir (DCV) / Asunaprevir (ASV) /BMS-791325 triple regimen is permitted. Examples of permitted agents include, but are not limited to nucleoside/nucleotide inhibitors of nonstructural protein 5B (NS5B) polymerase, inhibitors of cyclophilin, or inhibitors of microRNA.

You may not qualify if…

• Subjects without cirrhosis
• Liver or any other organ transplant
• Current or known history of cancer within 5 years prior to screening
• Documented or suspected hepatocellular carcinoma(HCC)
• Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy

Where it is running

• Scripps Clinic — La Jolla, California, United States
• 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 — Chicago, Illinois, United States
• Indiana University Health — Indianapolis, Indiana, United States
• Kansas City Care Clinic — Kansas City, Missouri, United States
• Kansas City Research Institute — Kansas City, Missouri, United States
• Binghamton Gastroenterology Associates — Binghamton, New York, United States
• Weill Cornell Medical College — New York, 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
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Lehigh Valley Health Network — Allentown, Pennsylvania, United States
• Quality Medical Research Pllc — Nashville, Tennessee, United States
• Advanced Liver Therapies — Houston, Texas, United States
• Texas Liver Institute — San Antonio, Texas, United States
• Mt Vernon Endoscopy Center — Alexandria, Virginia, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States
• Digestive And Liver Disease Specialists — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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