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

Phase 3

Completed

• Conditions: Hepatitis C
• Interventions: Drug: BMS-790052 (Daclatasvir); Drug: BMS-650032 (Asunaprevir)

• Registration Number: NCT01497834
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-02
• Study First Submitted QC: 2011-12-20
• Study First Posted: 2011-12-23
• Study Start: 2012-01
• Primary Completion: 2013-04
• Study Completion: 2013-06
• Status Verified: 2015-09
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Disposition First Posted: 2015-10-09
• Last Update Posted: 2015-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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

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Exclusion Criteria

Patients who have -

• Hepatocellular carcinoma
• Co-infection with Hepatitis B virus (HBV) or Human Immunodeficiency Virus (HIV)
• Severe or uncontrollable complication

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Daclatasvir + Asunaprevir	BMS-790052 (Daclatasvir)	-
Daclatasvir + Asunaprevir	BMS-650032 (Asunaprevir)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Chuo-shi, Yamanashi, Japan