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

NCT01718145 | Completed Phase 3

• 1 other identifier: AI447-031
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 48

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

Conditions

Hepatitis C Virus Infection

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the naive cohort

  * SVR12 = Sustained virologic response at post-treatment Week 12 * LLOQ = Lower Limit of quantitation

  After 12 weeks of the last dose

Secondary Outcomes (8)

• 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 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

• 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

• 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

Study Arms (3)

Arm 1: Daclatasvir + Asunaprevir

EXPERIMENTAL

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

Drug: Daclatasvir; Drug: Asunaprevir

Arm 2: Telaprevir + pegIFNα-2b + Ribavirin

ACTIVE COMPARATOR

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

Drug: Ribavirin; Biological: pegIFNα-2b; Drug: Telaprevir

Arm 3: Daclatasvir + Asunaprevir

EXPERIMENTAL

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

Drug: Daclatasvir; Drug: Asunaprevir

Interventions

Daclatasvir DRUG

Arm 1: Daclatasvir + Asunaprevir; Arm 3: Daclatasvir + Asunaprevir

Asunaprevir DRUG

Arm 1: Daclatasvir + Asunaprevir; Arm 3: Daclatasvir + Asunaprevir

Ribavirin DRUG

Arm 2: Telaprevir + pegIFNα-2b + Ribavirin

pegIFNα-2b BIOLOGICAL

Arm 2: Telaprevir + pegIFNα-2b + Ribavirin

Telaprevir DRUG

Arm 2: Telaprevir + pegIFNα-2b + Ribavirin

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (48)

Local Institution

Nagoya, Aichi-ken, 4668560, Japan

Location

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Toyoake Shi, Aichi-ken, 4701192, Japan

Location

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Chiba, Chiba, 2608677, Japan

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Fukui-shi, Fukui, 9188503, Japan

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Fukuoka, Fukuoka, 8108563, Japan

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Fukuoka, Fukuoka, 8140180, Japan

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Fukuoka, Fukuoka, 8158555, Japan

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Kurume, Fukuoka, 8300011, Japan

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Gifu, Gifu, 5008513, Japan

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Ogaki-shi, Gifu, 5038502, Japan

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Takasaki, Gunma, 3700829, Japan

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Hiroshima, Hiroshima, 7340037, Japan

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Obihiro-shi, Hokkaido, 080-0016, Japan

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Sapporo, Hokkaido, 0600033, Japan

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Sapporo, Hokkaido, 0608648, Japan

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Takamatsu, Kagawa-ken, 760-8557, Japan

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Kagoshima, Kagoshima-ken, 8908520, Japan

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Kawasaki-shi, Kanagawa, 2138587, Japan

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Yokohama, Kanagawa, 2360004, Japan

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Kumamoto, Kumamoto, 8608556, Japan

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Kumamoto, Kumamoto, 8628655, Japan

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Kyoto, Kyoto, 6028566, Japan

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Sendai, Miyagi, 9808574, Japan

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Matsumoto, Nagano, 3908621, Japan

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Nagasaki, Nagasaki, 8528501, Japan

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Ōmura, Nagasaki, 8568562, Japan

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Kashihara, Nara, 6348522, Japan

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Yufu, Oita Prefecture, 8795593, Japan

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Okayama, Okayama-ken, 7008558, Japan

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Osaka, Osaka, 5400006, Japan

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Osaka, Osaka, 5438555, Japan

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Osaka, Osaka, 5458586, Japan

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Osaka-sayama-shi, Osaka, 5898511, Japan

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Suita, Osaka, 5640013, Japan

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Suita-shi, Osaka, 5650871, Japan

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Iruma-gun, Saitama, 3500495, Japan

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Saitama, Saitama, 3380001, Japan

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Izunokuni, Shizuoka, 4102295, Japan

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Shimotsuke-shi, Tochigi, 3290498, Japan

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Bunkyo-ku, Tokyo, 1138519, Japan

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Bunkyo-ku, Tokyo, 1138655, Japan

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Minato-ku, Tokyo, 1058470, Japan

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Musashino-shi, Tokyo, 1808610, Japan

Location

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Shinagawa-ku, Tokyo, 1428666, Japan

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Yamagata, Yamagata, 9909585, Japan

Location

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Chuo-shi, Yamanashi, 4093898, Japan

Location

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Nagoya, 4678602, Japan

Location

Local Institution

Nishinomiya-shi, 6638501, Japan

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis C

Interventions

daclatasvir; asunaprevir; Ribavirin; telaprevir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: October 31, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: October 9, 2015

Record last verified: 2015-09

Locations

JP (48)