Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C Virus

In brief

To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.

Key facts

Study ID

NCT01125189

Run by

Bristol-Myers Squibb

People needed

558

Starts

2010-07-01

Expected to finish

2012-08-01

Last updated by the study team

2015-10-23

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients chronically infected with hepatitis C virus (HCV) genotype 1 or 4
• HCV RNA viral load of ≥100,000 IU/mL
• No previous exposure to interferon, pegIFNα, or RBV
• Results of a liver biopsy demonstrating absence of cirrhosis obtained ≤24 months prior to randomization. Compensated cirrhotics with Hepatitis C virus genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization)
• Findings on ultrasound, computed tomography scan, or magnetic resonance imaging 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma
• Body mass index of 18 to 35 kg/m\^2

You may not qualify if…

• Positive for hepatitis B or HIV-1/HIV-2 antibody at screening
• Evidence of a medical condition associated with chronic liver disease other than HCV
• Evidence of decompensated cirrhosis based on radiologic criteria or biopsy

Where it is running

• Scripps Clinic — La Jolla, California, United States
• Cli — Los Angeles, California, United States
• Desta Digestive Disease Medical Center — San Diego, California, United States
• University Of California, San Francisco/Sf General Hospital — San Francisco, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• Kaiser Permanente Medical Center — San Francisco, California, United States
• Transplant Center And Hepatology Clinic, B-154 — Aurora, Colorado, United States
• Yale University School Of Medicine — New Haven, Connecticut, United States
• University Of Florida Hepatology — Gainesville, Florida, United States
• University Of Miami — Miami, Florida, United States
• Miami Research Associates — South Miami, Florida, United States
• Indiana University — Indianapolis, Indiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Mercy Medical Center — Baltimore, Maryland, United States
• Digestive Disease Associates, P.A. — Baltimore, Maryland, United States
• Johns Hopkins University — Lutherville, Maryland, United States
• Claudia T. Martorell, Md, Llc — Springfield, Massachusetts, United States
• James Sungsik Park, M.D. C.N.S.C. — Great Neck, New York, United States
• Upper Delaware Valley Infectious Diseases, Pc — Monticello, New York, United States
• James J Peters Vamc — The Bronx, New York, United States
• University Of North Carolina At Chapel Hill School Of Med — Chapel Hill, North Carolina, United States
• Carolinas Center For Liver Disease — Statesville, North Carolina, United States
• Options Health Research, Llc — Tulsa, Oklahoma, United States
• Healthcare Research Consultants — Tulsa, Oklahoma, United States
• Alabama Liver & Digestive Specialists (Alds) — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

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