Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients

Bristol-Myers Squibb51 enrolled

Overview

The purpose of this study is to identify at least 1 dose of daclatasvir that is safe, well tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the treatment of hepatitis C virus genotype 1 in chronically infected patients who are treatment-naïve and nonresponsive to the standard of care

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hepatitis C Infection

Interventions

BMS-790052DRUG

Tablets, Oral, 10 mg, daily, 24-48 weeks

BMS-790052DRUG

Tablets, Oral, 60 mg, daily, 24-48 weeks

PlaceboDRUG

Tablets, Oral, 0 mg, daily, 48 weeks

Peginterferon alfa-2b

Eligibility

Sex: ALLMin age: 20 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 ≥10\*5\* IU/mL at screening * Naïve or nonresponsive to the current standard of care Key Exclusion Criteria: * Cirrhosis * Hepatocellular carcinoma * Coinfection with hepatitis B virus, HIV-1 or HIV-2

Locations (6)

Local Institution

Hiroshima, Hiroshima, Japan

Local Institution

Sapporo, Hokkaido, Japan

Local Institution

Kawasaki-Shi, Kanagawa, Japan

Local Institution

Suita-Shi, Osaka, Japan

Outcomes

Primary Outcomes

Percentage of Participants With Extended Rapid Virologic Response (eRVR)

eRVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \<15 IU/mL, the lower limit of detection, target not detected) at both Weeks 4 and 12. HCV RNA levels were measured by Tobas TaqMan HCV Auto from the central laboratory.

Time frame: At Weeks 4 and 12 on treatment

Secondary Outcomes

Percentage of Participants With Rapid Virologic Response (RVR)

RVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \<15 IU/mL, the lower limit of detection, target not detected) at Week 4. HCV RNA levels were measured by CobasTaqMan HCV Auto from the central laboratory .

Time frame: At Week 4 on treatment

Percentage of Participants With Complete Early Virologic Response (cEVR)

cEVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \<15 IU/mL, the lower limit of detection, target not detected) at Week 12 on treatment. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory

Time frame: At Week 12 on treatment

Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24

SVR at follow-up Week 4 (SVR4), follow-up Week 12 (SVR12), and follow-up Week 24 (SVR24) is defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \<15 IU/mL, the lower limit of detection, target not detected) at each of these timepoints. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory .

Time frame: Follow-up Weeks 4, 12, and 24

Percentage of Participants With Virologic Failure

Virologic failure is defined by the following 6 categories: 1.Virologic breakthrough, defined as confirmed \>1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed HCV RNA ≥limit of quantitation (LOQ) after confirmed undetectable HCV RNA while on treatment. 2. \<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment. 3. Failure to achieve early virologic response, defined as \<2 log10 decrease in HCV RNA from baseline at Week 12 of treatment. 4. Detectable HCV RNA at Week 12, and HCV RNA ≥LOQ at Week 24 of treatment. 5. Detectable HCV RNA at end of treatment (including early discontinuation). 6 Relapse, defined as detectable HCV RNA during follow-up after undetectable HCV RNA levels at end of treatment.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.