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: July 9, 2014
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: December 2014
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Fukuoka, Japan, 8300011
Local Institution
Ogaki-shi, Gifu, Japan, 5038502
Local Institution
Takasaki City, Gunma, Japan, 3700829
Local Institution
Hiroshima-shi, Hiroshima, Japan, 7340037
Local Institution
Obihiro-shi, Hokkaido, Japan, 080-0016
Local Institution
Sapporo-shi, Hokkaido, Japan, 0608648
Local Institution
Sapporo-shi, Hokkaido, Japan, 0600033
Local Institution
Takamatsu-shi, Kagawa, Japan, 760-8557
Local Institution
Kagoshima-shi, Kagoshima, Japan, 8908520
Local Institution
Kawasaki-shi, Kanagawa, Japan, 2138587
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, Nagano, Japan, 3908621
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, 5458586
Local Institution
Osaka-shi, Osaka, Japan, 5438555
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, 9909585
Local Institution
Chuo-shi, Yamanashi, Japan, 4093898
Local Institution
Fukui, Japan, 9188503
Local Institution
Fukuoka, Japan, 8158555
Local Institution
Fukuoka, Japan, 8140180
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: July 9, 2014
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 July 20, 2014