BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C

Completed · Phase 3

Conditions studied: Hepatitis C

In brief

The purpose of this study is to compare the rates of sustained virologic response in each cohort (Black-African Americans, Latinos) in this study to historical rate.

Key facts

Study ID

NCT01389323

Run by

Bristol-Myers Squibb

People needed

448

Starts

2011-09-01

Expected to finish

2014-01-01

Last updated by the study team

2015-10-12

Who can join

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

You may qualify if…

• Participants chronically infected with Hepatitis C virus (HCV) genotype 1
• HCV RNA viral load of ≥10,000 IU/mL at screening
• No previous exposure to interferon formulation, ribavirin or HCV direct antiviral agent
• Self-described as Black-African American, Latino or White-Caucasian
• Results of a liver biopsy obtained ≤36 months prior to first treatment compensated cirrhotics with HCV liver biopsy from any time prior to first treatment.
• Compensated cirrhotics were capped at approximately 25%

You may not qualify if…

• Evidence of decompensated liver disease
• Documented or suspected Hepatocellular carcinoma (HCC)
• Positive for Hepatitis B or HIV 1/HIV 2 antibody at screening

Where it is running

• Alabama Liver & Digestive Specialists (Alds) — Montgomery, Alabama, United States
• Va Long Beach Healthcare System - 11 — Long Beach, California, United States
• Axis Clinical Trials — Los Angeles, California, United States
• Greater Los Angeles Healthcare System — Los Angeles, California, United States
• University Of California, Davis Medical Center — Sacramento, California, United States
• Ucsd Antiviral Research Center (Avrc) — San Diego, California, United States
• Precision Research Institute, Llc — San Diego, California, United States
• Medical Associates Research Group, Inc — San Diego, California, United States
• Miami V.A. Healthcare System — Maimi, Florida, United States
• University Of Miami — Miami, Florida, United States
• Florida Hospital Transplant Center — Orlando, Florida, United States
• Infectious Disease Research Institute, Inc — Tampa, Florida, United States
• South Florida Center Of Gastroenterology, P.A. — Wellington, Florida, United States
• Triple O Research Institute, P.A. — West Palm Beach, Florida, United States
• Atlanta Medical Center — Atlanta, Georgia, United States
• The Emory Clinic — Atlanta, Georgia, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• Mercy Medical Center — Baltimore, Maryland, United States
• Digestive Disease Associates, P.A. — Baltimore, Maryland, United States
• The Research Institute — Springfield, Massachusetts, United States
• Digestive Health Center — Ocean Springs, Mississippi, United States
• Montefiore Medical Center — The Bronx, New York, United States
• University Of North Carolina At Chapel Hill School Of Med — Chapel Hill, North Carolina, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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