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

NCT ID: NCT01718145

Last Updated: 2015-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-12-31

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

Conditions

Hepatitis C Virus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1: Daclatasvir + Asunaprevir

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

• Naive cohort

Group Type: EXPERIMENTAL

Daclatasvir

Intervention Type: DRUG

Asunaprevir

Intervention Type: DRUG

Arm 2: Telaprevir + pegIFNα-2b + 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

Group Type: ACTIVE_COMPARATOR

Ribavirin

Intervention Type: DRUG

pegIFNα-2b

Intervention Type: BIOLOGICAL

Telaprevir

Intervention Type: DRUG

Arm 3: Daclatasvir + Asunaprevir

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

• Relapser cohort

Group Type: EXPERIMENTAL

Daclatasvir

Intervention Type: DRUG

Asunaprevir

Intervention Type: DRUG

Interventions

Daclatasvir

Intervention Type: DRUG

Asunaprevir

Intervention Type: DRUG

Ribavirin

Intervention Type: DRUG

pegIFNα-2b

Intervention Type: BIOLOGICAL

Telaprevir

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution

Nagoya, Aichi-ken, Japan

Local Institution

Toyoake Shi, Aichi-ken, Japan

Local Institution

Chiba, Chiba, Japan

Local Institution

Fukui-shi, Fukui, Japan

Local Institution

Fukuoka, Fukuoka, Japan

Local Institution

Fukuoka, Fukuoka, Japan

Local Institution

Fukuoka, Fukuoka, Japan

Local Institution

Kurume, Fukuoka, Japan

Local Institution

Gifu, Gifu, Japan

Local Institution

Ogaki-shi, Gifu, Japan

Local Institution

Takasaki, Gunma, Japan

Local Institution

Hiroshima, Hiroshima, Japan

Local Institution

Obihiro-shi, Hokkaido, Japan

Local Institution

Sapporo, Hokkaido, Japan

Local Institution

Sapporo, Hokkaido, Japan

Local Institution

Takamatsu, Kagawa-ken, Japan

Local Institution

Kagoshima, Kagoshima-ken, Japan

Local Institution

Kawasaki-shi, Kanagawa, Japan

Local Institution

Yokohama, Kanagawa, Japan

Local Institution

Kumamoto, Kumamoto, Japan

Local Institution

Kumamoto, Kumamoto, Japan

Local Institution

Kyoto, Kyoto, Japan

Local Institution

Sendai, Miyagi, Japan

Local Institution

Matsumoto, Nagano, Japan

Local Institution

Nagasaki, Nagasaki, Japan

Local Institution

Ōmura, Nagasaki, Japan

Local Institution

Kashihara, Nara, Japan

Local Institution

Yufu, Oita Prefecture, Japan

Local Institution

Okayama, Okayama-ken, Japan

Local Institution

Osaka, Osaka, Japan

Local Institution

Osaka, Osaka, Japan

Local Institution

Osaka, Osaka, Japan

Local Institution

Osaka-sayama-shi, Osaka, Japan

Local Institution

Suita, Osaka, Japan

Local Institution

Suita-shi, Osaka, Japan

Local Institution

Iruma-gun, Saitama, Japan

Local Institution

Saitama, Saitama, Japan

Local Institution

Izunokuni, Shizuoka, Japan

Local Institution

Shimotsuke-shi, Tochigi, Japan

Local Institution

Bunkyo-ku, Tokyo, Japan

Local Institution

Bunkyo-ku, Tokyo, Japan

Local Institution

Minato-ku, Tokyo, Japan

Local Institution

Musashino-shi, Tokyo, Japan

Local Institution

Shinagawa-ku, Tokyo, Japan

Local Institution

Yamagata, Yamagata, Japan

Local Institution

Chuo-shi, Yamanashi, Japan

Local Institution

Nagoya, , Japan

Local Institution

Nishinomiya-shi, , Japan

Countries

Japan

Related Links

http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

AI447-031

Identifier Type: -

Identifier Source: org_study_id