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

Phase 3

Completed

• Conditions: Hepatitis C Virus Infection
• Interventions: Drug: Daclatasvir; Drug: Ribavirin; Biological: pegIFNα-2b; Drug: Asunaprevir; Drug: Telaprevir

• Registration Number: NCT01718145
• 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 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

Detailed Description

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

Study Timeline

• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2012-10-29
• Study First Posted: 2012-10-31
• Study Start: 2012-11
• Primary Completion: 2013-12
• Study Completion: 2014-12
• 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: 258

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

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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: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: Telaprevir + pegIFNα-2b + Ribavirin	pegIFNα-2b	Telaprevir 750 mg tablets by mouth three times daily, pegIFNα-2b 1.5 μg/kg solution by Subcutaneous weekly \& Ribavirin 600- 1000 mg Capsules by mouth twice daily for 24 Weeks - Naive cohort
Arm 1: Daclatasvir + Asunaprevir	Asunaprevir	Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks - Naive cohort
Arm 1: Daclatasvir + Asunaprevir	Daclatasvir	Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks - Naive cohort
Arm 2: Telaprevir + pegIFNα-2b + Ribavirin	Ribavirin	Telaprevir 750 mg tablets by mouth three times daily, pegIFNα-2b 1.5 μg/kg solution by Subcutaneous weekly \& Ribavirin 600- 1000 mg Capsules by mouth twice daily for 24 Weeks - Naive cohort
Arm 2: Telaprevir + pegIFNα-2b + Ribavirin	Telaprevir	Telaprevir 750 mg tablets by mouth three times daily, pegIFNα-2b 1.5 μg/kg solution by Subcutaneous weekly \& Ribavirin 600- 1000 mg Capsules by mouth twice daily for 24 Weeks - Naive cohort
Arm 3: Daclatasvir + Asunaprevir	Daclatasvir	Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks - Relapser cohort
Arm 3: Daclatasvir + Asunaprevir	Asunaprevir	Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks - Relapser cohort

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the naive cohort	After 12 weeks of the last dose	* SVR12 = Sustained virologic response at post-treatment Week 12; * LLOQ = Lower Limit of quantitation

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the naive cohort	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	EOT = End of treatment
Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the relapser cohort	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
Proportion of subjects with HCV RNA target not detected in the relapser cohort	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
On treatment safety, as measured by the frequency of Severe adverse events (SAEs), discontinuation and dose modification/interruption due to Adverse events (AEs), Grade 3-4 abnormalities observed from clinical laboratory tests for each treatment group	End of treatment (24 weeks) plus 7days
Proportion of subjects with hemoglobin < 10g/dL	First 12 weeks of treatment
Proportion of subjects with rash-related dermatologic events	First 12 weeks of treatment
Proportion of subjects with HCV RNA target not detected in the naive cohort	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	eRVR = Extended rapid virologic response
Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the relapser cohort	At post-treatment Week 12

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Saitama, Japan