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

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

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01497834

Enrollment

224

Registered

2011-12-23

Start date

2012-01-31

Completion date

2013-06-30

Last updated

2015-10-09

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

Conditions

Hepatitis C

Keywords

Hepatitis C Virus Infection

Brief summary

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

Interventions

DRUGBMS-790052 (Daclatasvir)

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

DRUGBMS-650032 (Asunaprevir)

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Antiviral activity, as determined by the proportion of subjects with SVR24	After 24 weeks of the last dose	SVR24 - sustained virologic response at follow-up Week 24 (after end of treatment)

Secondary

Measure	Time frame
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	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	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	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)]	Follow-up Week 24

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026