NCT01389323
BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C
PHASE3
COMPLETED
NCT01389323
INTERVENTIONAL
Open-Label, Single Arm Evaluation of BMS-790052 (Daclatasvir) in Combination With Peg-Interferon Alfa-2a and Ribavirin in Black-African Americans, Latinos and White-Caucasians With Chronic Hepatitis C Genotype 1 Infection
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.
Inclusion Criteria:
* 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%
Exclusion Criteria:
* Evidence of decompensated liver disease
* Documented or suspected Hepatocellular carcinoma (HCC)
* Positive for Hepatitis B or HIV 1/HIV 2 antibody at screening
Hepatitis C
- TREATMENT
-
- Type: DRUG
- Name: Daclatasvir
- Description: Tablet, Oral, 60 mg, once daily, 24 weeks
- Arm Group Labels: Arm 1: Daclatasvir + Peg-Interferon Alfa-2a + Ribavirin
-
- Type: DRUG
- Name: Peg-Interferon Alfa-2a
- Description: Syringe, Subcutaneous Injection, 180 μg, Once weekly, 24 or 48 weeks depending on response
- Arm Group Labels: Arm 1: Daclatasvir + Peg-Interferon Alfa-2a + Ribavirin
-
- Type: DRUG
- Name: Ribavirin
- Description: Tablet, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 or 48 weeks depending on response
- Arm Group Labels: Arm 1: Daclatasvir + Peg-Interferon Alfa-2a + Ribavirin
- Bristol-Myers Squibb