Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)

Bristol-Myers Squibb74 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hepatitis C Infection

Interventions

DaclatasvirDRUG

Tablets, oral, 3 mg, Daily, 48 weeks

DaclatasvirDRUG

Tablets, oral, 10 mg, Daily, 48 weeks

DaclatasvirDRUG

Tablets, oral, 60 mg, Daily, 48 weeks

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * 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 Exclusion Criteria: * Women of child-bearing potential * Cirrhosis * Coinfection with HIV or hepatitis B virus

Locations (14)

Alabama Liver & Digestive Specialists (Alds)

Montgomery, Alabama, United States

University Of Colorado Denver & Hospital

Aurora, Colorado, United States

Yale University School Of Medicine

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Percentage of Participants With Extended Rapid Virologic Response (eRVR) at 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.

Time frame: A Weeks 4 and 12

Secondary Outcomes

Percentage of Participants With Rapid Virologic Response (RVR) 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.

Time frame: At Week 4

Percentage of Participants With Early Virologic Response (EVR) 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.

Time frame: At Week 12

Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12

cEVR was defined as hepatitis C virus RNA \<10 IU/mL at Week 12

Time frame: At Week 12

Data from ClinicalTrials.gov

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