A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects

Bristol-Myers Squibb258 enrolled

Overview

The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subject. The purpose of this study is to compare the anti-viral activity of the co-administration of Asunaprevir (ASV) and Daclatasvir (DCV) to Telaprevir (TVR) included therapy in Japanese Hepatitis C virus (HCV) subjects

Intervention Model: Parallel in the Naive cohort and Single group in the Relapser cohort

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

258

Conditions

Hepatitis C Virus Infection

Interventions

DaclatasvirDRUG

AsunaprevirDRUG

RibavirinDRUG

pegIFNα-2bBIOLOGICAL

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Chronic HCV-1b infected patient * HCV Ribonucleic acid (RNA) \> 100,000 IU/mL at screening * Ages 20 to 70 years (for the Naive cohort), ages 20 to 75 years (for the Relapser cohort) * Treatment naive subjects to Interferon (IFN) based therapy * Subjects who had undetectable HCV RNA at end of treatment with prior exposure to an IFN-containing regimen, but HCV RNA detectable within 24 weeks of treatment follow-up Exclusion Criteria: * Patients who have; * Hepatocellular carcinoma * Co-infection with Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV) * Severe or uncontrollable complication

Locations (48)

Outcomes

Primary Outcomes

Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the naive cohort

* SVR12 = Sustained virologic response at post-treatment Week 12 * LLOQ = Lower Limit of quantitation

Time frame: After 12 weeks of the last dose

Secondary Outcomes

Proportion of subjects with hemoglobin < 10g/dL

Time frame: First 12 weeks of treatment

Proportion of subjects with rash-related dermatologic events

Time frame: First 12 weeks of treatment

Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the naive cohort

EOT = End of treatment

Time frame: At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12; EOT (up to 24 weeks), post-treatment Week 4 and post-treatment Week 24

Proportion of subjects with HCV RNA target not detected in the naive cohort

eRVR = Extended rapid virologic response

Time frame: At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 4, post-treatment Week 12 and post-treatment Week 24

Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the relapser cohort

Time frame: At post-treatment Week 12

Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the relapser cohort

Time frame: At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12; EOT (up to 24 weeks), post-treatment Week 4 and Week 24

Data from ClinicalTrials.gov

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Local Institution

Nagoya, Aichi-ken, Japan

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Toyoake Shi, Aichi-ken, Japan

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Chiba, Chiba, Japan

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Fukui-shi, Fukui, Japan

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Fukuoka, Fukuoka, Japan

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Fukuoka, Fukuoka, Japan

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Fukuoka, Fukuoka, Japan

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Kurume, Fukuoka, Japan

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Gifu, Gifu, Japan

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Ogaki-shi, Gifu, Japan

...and 38 more locations