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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01718145
First received: October 29, 2012
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Hepatitis C Virus Infection
Drug: Daclatasvir
Drug: Asunaprevir
Drug: Ribavirin
Biological: pegIFNα-2b
Drug: Telaprevir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Comparative Study of Asunaprevir and Daclatasvir (DUAL) Combination Therapy Versus Telaprevir Therapy in Japanese Genotype 1b Chronic Hepatitis C IFN Eligible-naive Subjects With a Single Arm Assessment of DUAL Therapy in IFN-therapy Relapsers

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the naive cohort [ Time Frame: After 12 weeks of the last dose ] [ Designated as safety issue: No ]
    • SVR12 = Sustained virologic response at post-treatment Week 12
    • LLOQ = Lower Limit of quantitation


Secondary Outcome Measures:
  • Proportion of subjects with hemoglobin < 10g/dL [ Time Frame: First 12 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with rash-related dermatologic events [ Time Frame: First 12 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the naive cohort [ Time Frame: 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 ] [ Designated as safety issue: No ]
    EOT = End of treatment

  • Proportion of subjects with HCV RNA target not detected in the naive cohort [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: At post-treatment Week 12 ] [ Designated as safety issue: No ]
  • Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the relapser cohort [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Proportion of subjects with HCV RNA target not detected in the relapser cohort [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: End of treatment (24 weeks) plus 7days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 224
Study Start Date: November 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

Drug: Daclatasvir Drug: Asunaprevir
Active Comparator: 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

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

Drug: Daclatasvir Drug: Asunaprevir

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718145

Locations
Japan
Local Institution
Nagoya-shi, Aichi, Japan, 4668560
Local Institution
Toyoake-shi, Aichi, Japan, 4701192
Local Institution
Chiba-Shi, Chiba, Japan, 2608677
Local Institution
Fukuoka-shi, Fukuoka, Japan, 8108563
Local Institution
Kurume-shi, Fukuoka, Japan, 8390863
Local Institution
Ogaki-shi, Gifu, Japan, 5038502
Local Institution
Takasaki City, Gunma, Japan, 3700829
Local Institution
Hiroshima-shi, Hiroshima, Japan, 7348511
Local Institution
Obihiro-Shi, Hokkaido, Japan, 080-0016
Local Institution
Sapporo-Shi, Hokkaido, Japan, 0600033
Local Institution
Sapporo-Shi, Hokkaido, Japan, 0608648
Local Institution
Takamatsu-shi, Kagawa, Japan, 7608557
Local Institution
Kagoshima-shi, Kagoshima, Japan, 8908520
Local Institution
Yokohama-shi, Kanagawa, Japan, 2360004
Local Institution
Kumamoto-Shi, Kumamoto, Japan, 8608556
Local Institution
Kyoto-Shi, Kyoto, Japan, 6028566
Local Institution
Sendai-Shi, Miyagi, Japan, 9808574
Local Institution
Matsumoto City, Nagano, Japan, 390-0802
Local Institution
Nagasaki-shi, Nagasaki, Japan, 8528501
Local Institution
Omura, Nagasaki, Japan, 8568562
Local Institution
Kashihara, Nara, Japan, 6348522
Local Institution
Yufu, Oita, Japan, 8795593
Local Institution
Okayama-shi, Okayama, Japan, 7008558
Local Institution
Osaka-sayama-shi, Osaka, Japan, 5898511
Local Institution
Osaka-shi, Osaka, Japan, 5438555
Local Institution
Osaka-shi, Osaka, Japan, 5458586
Local Institution
Suita, Osaka, Japan, 5640013
Local Institution
Suita-shi, Osaka, Japan, 5650871
Local Institution
Iruma-gun, Saitama, Japan, 3500495
Local Institution
Izunokuni, Shizuoka, Japan, 4102295
Local Institution
Shimotsuke-Shi, Tochigi, Japan, 3290498
Local Institution
Bunkyo-Ku, Tokyo, Japan, 1138519
Local Institution
Bunkyo-Ku, Tokyo, Japan, 1138655
Local Institution
Minato-ku, Tokyo, Japan, 1058470
Local Institution
Musashino-shi, Tokyo, Japan, 1808610
Local Institution
Shinagawa-Ku, Tokyo, Japan, 1428666
Local Institution
Yamagata-shi, Yamagata, Japan, 990-21
Local Institution
Chuo-shi, Yamanashi, Japan, 4093898
Local Institution
Fukui, Japan, 9188503
Local Institution
Fukuoka, Japan, 8140180
Local Institution
Fukuoka, Japan, 8158555
Local Institution
Gifu, Japan, 5008513
Local Institution
Kumamoto, Japan, 8628655
Local Institution
Nagoya-Shi, Japan, 4678602
Local Institution
Nishinomiya-Shi, Japan, 6638501
Local Institution
Osaka, Japan, 5400006
Local Institution
Saitama, Japan, 3380001
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01718145     History of Changes
Other Study ID Numbers: AI447-031
Study First Received: October 29, 2012
Last Updated: April 12, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014