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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: September 18, 2014
Last verified: September 2014
  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 lower limit of quantitation (LLOQ) target detected or not detected [ 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 HCV RNA below LLOQ, target not detected [ 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 serious 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: June 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
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: 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: September 18, 2014
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
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014