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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Virus Infection

Treatments: Drug: Daclatasvir; Drug: Asunaprevir; Drug: Ribavirin; Drug: Telaprevir; Biological: pegIFNα-2b

Study type: Interventional

Funder types: Industry

Identifiers

NCT01718145

AI447-031

Details and patient eligibility

About

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

Full description

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

Enrollment: 258 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Patients who have;

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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258 participants in 3 patient groups

Arm 1: Daclatasvir + Asunaprevir

Experimental group

Description:

Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks - Naive cohort

Treatment:

Drug: Asunaprevir

Drug: Daclatasvir

Arm 2: Telaprevir + pegIFNα-2b + Ribavirin

Active Comparator group

Description:

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

Treatment:

Drug: Telaprevir

Drug: Ribavirin

Biological: pegIFNα-2b

Arm 3: Daclatasvir + Asunaprevir

Experimental group

Description:

Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks - Relapser cohort

Treatment:

Drug: Asunaprevir

Drug: Daclatasvir