A phase 3 Study of BMS-790052 plus BMS-650032 combination Therapy in Chronic Hepatitis C Genotype 1b Infected Subjects

A Phase 3 Japanese Study of BMS-790052 plus BMS-650032 Combination Therapy in Chronic Hepatitis C Genotype 1b Infected Subjects Who are Non Response to Interferon plus Ribavirin and Interferon Based Therapy Ineligible naive/intolerant

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221687

Enrollment

200

Registered

2012-01-10

Start date

2012-01-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Interventions

investigational material(s) Generic name etc : BMS-650032 INN of investigational material : Therapeutic category code : 625 Anti-virus agents Dosage and Administration for Investigational material :

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - chronic HCV-1b infected patient - HCV RNA >= 100,000 IU/mL at screening - non-responder to interferon plus ribavirin therapy - patient who has been excluded from interferon/ribavirin therapy or intolerant for interferon/ribavirin therapy

Exclusion criteria

Exclusion criteria: Patients who have; - hepatocellular carcinoma - co-infection with HBV or HIV - severe or uncontrollable complication

Design outcomes

Primary

Measure	Time frame
To assess antiviral activity, as determined by the proportion of subjects with SVR.	—

Secondary

Measure	Time frame
- To assess safety - To assess the antiviral activity, as determined by the proportion of subjects who acheive undetectable (or below LOQ) HCV RNA at each scheduled visit. - To assess the relationship between efficacy and the single nucleotide polymorphisms (SNPs) in the IL28B gene	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026