We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01497834
Recruitment Status : Completed
First Posted : December 23, 2011
Last Update Posted : October 9, 2015
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Antiviral activity, as determined by the proportion of subjects with SVR24 [ Time Frame: After 24 weeks of the last dose ]
    SVR24 - sustained virologic response at follow-up Week 24 (after end of treatment)

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01497834

Layout table for location information
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-shi, Osaka, Japan, 5650871
Local Institution
Suita, Osaka, Japan, 5640013
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
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01497834    
Other Study ID Numbers: AI447-026
First Posted: December 23, 2011    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: September 2015
Keywords provided by Bristol-Myers Squibb:
Hepatitis C Virus Infection
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action