A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01497834
First received: December 2, 2011
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subjects.


Condition Intervention Phase
Hepatitis C
Drug: BMS-790052 (Daclatasvir)
Drug: BMS-650032 (Asunaprevir)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3 Japanese Study of BMS-790052 Plus BMS-650032 Combination Therapy in Chronic Hepatitis C Genotype 1b Infected Subjects Who Are Non Response to Interferon Plus Ribavirin and Interferon Based Therapy Ineligible Naive/Intolerant

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Antiviral activity, as determined by the proportion of subjects with SVR24 [ Time Frame: After 24 weeks of the last dose ] [ Designated as safety issue: No ]
    SVR24 - sustained virologic response at follow-up Week 24 (after end of treatment)


Secondary Outcome Measures:
  • Antiviral activity, as determined by the proportion of subjects who achieve Hepatitis C virus (HCV) ribonucleic acid (RNA) below limit of quantitation (LOQ) [ Time Frame: Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; End of treatment (EOT), or post treatment Week 12 ] [ Designated as safety issue: No ]
  • Antiviral activity, as determined by the proportion of subjects who achieve undetectable HCV RNA [ Time Frame: Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; EOT, or post treatment Week 12, post treatment Week 24 ] [ Designated as safety issue: No ]
  • Safety, as measured by the frequency of severe adverse events (SAEs), discontinuations due to adverse events (AEs), AEs by intensity and laboratory abnormalities by toxicity grade [ Time Frame: End of treatment plus 7 days ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with SVR24 by IL28B status [CC, CT, or TT genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNP)] [ Time Frame: Follow-up Week 24 ] [ Designated as safety issue: No ]

Enrollment: 224
Study Start Date: January 2012
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Daclatasvir + Asunaprevir Drug: BMS-790052 (Daclatasvir)
Tablets, Oral, 60mg, Once daily, 24 weeks
Drug: BMS-650032 (Asunaprevir)
Capsules, Oral, 100mg, Twice daily, 24 weeks

  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 RNA viral load of ≥ 100,000 IU/mL at screening
  • Ages 20 to 75 years
  • Non-responder to Interferon plus Ribavirin therapy
  • Patient who has been excluded from interferon/ribavirin therapy or intolerant for Interferon/Ribavirin therapy

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: NCT01497834

Locations
Japan
Local Institution
Nagoya-shi, Aichi, Japan, 4668560
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
Hiroshima-shi, Hiroshima, Japan, 7340037
Local Institution
Sapporo-Shi, Hokkaido, Japan, 0600033
Local Institution
Amagasaki-shi, Hyogo, Japan, 6608511
Local Institution
Kanazawa-shi, Ishikawa, Japan, 9208641
Local Institution
Takamatsu-shi, Kagawa, Japan, 7608557
Local Institution
Kagoshima-shi, Kagoshima, Japan, 8908520
Local Institution
Kawasaki-Shi, Kanagawa, Japan, 2138587
Local Institution
Sendai-Shi, Miyagi, Japan, 9808574
Local Institution
Okayama-shi, Okayama, Japan, 7008558
Local Institution
Osaka-sayama-shi, Osaka, Japan, 5898511
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, 350-0495
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
Chuo-shi, Yamanashi, Japan, 4093898
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: NCT01497834     History of Changes
Other Study ID Numbers: AI447-026
Study First Received: December 2, 2011
Last Updated: May 31, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bristol-Myers Squibb:
Hepatitis C Virus Infection

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 17, 2014