Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)
- Conditions
- Hepatitis C Infection
- Interventions
- Registration Number
- NCT00874770
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in combination with pegylated interferon alpha and ribavirin, are safe and demonstrate sufficient anti-hepatitis C virus activity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
- Patients chronically infected with hepatitis C virus (HCV) genotype 1
- HCV RNA viral load of ≥10*5* IU/mL (100,000 IU/mL) at screening
- Treatment naive
Key
- Women of child-bearing potential
- Cirrhosis
- Coinfection with HIV or hepatitis B virus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo, Peginterferon alpha-2a, ribavirin (D) Placebo - Placebo, Peginterferon alpha-2a, ribavirin (D) Peginterferon alpha-2a - Daclatasvir, Peginterferon alpha-2a, ribavirin (B) Peginterferon alpha-2a Active Comparator Daclatasvir, Peginterferon alpha-2a, ribavirin (C) Daclatasvir Active Comparator Daclatasvir, Peginterferon alpha-2a, ribavirin (C) Peginterferon alpha-2a Active Comparator Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A) Peginterferon alpha-2a Active Comparator Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A) ribavirin Active Comparator Daclatasvir, Peginterferon alpha-2a, ribavirin (C) ribavirin Active Comparator Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A) Daclatasvir Active Comparator Daclatasvir, Peginterferon alpha-2a, ribavirin (B) Daclatasvir Active Comparator Daclatasvir, Peginterferon alpha-2a, ribavirin (B) ribavirin Active Comparator Placebo, Peginterferon alpha-2a, ribavirin (D) ribavirin -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12 A Weeks 4 and 12 eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12 At Week 12 cEVR was defined as hepatitis C virus RNA \<10 IU/mL at Week 12
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 At Week 4 RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA less than the lower limit of detection (10 IU/mL) at Week 4.
Percentage of Participants With Early Virologic Response (EVR) at Week 12 At Week 12 EVR was defined as a ≥2 log10 decrease in hepatitis C virus (HCV) RNA from baseline at Week 12 , or HCV RNA \<10 IU/mL for participants with baseline HCV RNA \<1000 IU/mL.
Trial Locations
- Locations (12)
Alabama Liver & Digestive Specialists (Alds)
🇺🇸Montgomery, Alabama, United States
Llc Dba The Research Institute
🇺🇸Springfield, Massachusetts, United States
Veterans Affairs Medical Center
🇺🇸Bronx, New York, United States
Options Health Research, Llc
🇺🇸Tulsa, Oklahoma, United States
Healthcare Research Consultants
🇺🇸Tulsa, Oklahoma, United States
North Texas Research Institute
🇺🇸Arlington, Texas, United States
Local Institution
🇫🇷Vandoeuvre Les Nancy, France
Metropolitan Research
🇺🇸Fairfax, Virginia, United States
University Of Colorado Denver & Hospital
🇺🇸Aurora, Colorado, United States
Yale University School Of Medicine
🇺🇸New Haven, Connecticut, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
Carolinas Center For Liver Disease
🇺🇸Statesville, North Carolina, United States