A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients

Bristol-Myers Squibb224 enrolled

Overview

The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subjects.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

224

Conditions

Hepatitis C

Interventions

BMS-790052 (Daclatasvir)DRUG

Tablets, Oral, 60mg, Once daily, 24 weeks

BMS-650032 (Asunaprevir)DRUG

Capsules, Oral, 100mg, Twice daily, 24 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Chronic HCV-1b infected patient * HCV RNA viral load of ≥ 100,000 IU/mL at screening * Ages 20 to 75 years * Non-responder to Interferon plus Ribavirin therapy * Patient who has been excluded from interferon/ribavirin therapy or intolerant for Interferon/Ribavirin therapy Exclusion Criteria: Patients who have - * Hepatocellular carcinoma * Co-infection with Hepatitis B virus (HBV) or Human Immunodeficiency Virus (HIV) * Severe or uncontrollable complication

Locations (24)

Local Institution

Nagoya, Aichi-ken, Japan

Local Institution

Chiba, Chiba, Japan

Outcomes

Primary Outcomes

Antiviral activity, as determined by the proportion of subjects with SVR24

SVR24 - sustained virologic response at follow-up Week 24 (after end of treatment)

Time frame: After 24 weeks of the last dose

Secondary Outcomes

Antiviral activity, as determined by the proportion of subjects who achieve Hepatitis C virus (HCV) ribonucleic acid (RNA) below lower limit of quantitation (LLOQ) target detected or not detected

Time frame: Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; End of treatment (EOT), or post treatment Week 12

Antiviral activity, as determined by the proportion of subjects who achieve HCV RNA below LLOQ, target not detected

Time frame: Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; EOT, or post treatment Week 12, post treatment Week 24

Safety, as measured by the frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), AEs by intensity and laboratory abnormalities by toxicity grade

Time frame: End of treatment plus 7 days

Proportion of subjects with SVR24 by IL28B status [CC, CT, or TT genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNP)]

Time frame: Follow-up Week 24

Data from ClinicalTrials.gov

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