An Anti-viral Combination Study With Japanese Hepatitis C Infection (HCV) Subject

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. Identifier: NCT01051414
Recruitment Status : Completed
First Posted : January 18, 2010
Last Update Posted : October 9, 2015
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
To assess the efficacy and safety profile of co-administration of BMS-790052 and BMS-650032 for 24 weeks treatment.

Condition or disease Intervention/treatment Phase
Hepatitis C Infection Drug: BMS-790052 Drug: BMS-650032 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2a Study of BMS-790052 and BMS-650032 in Combination Therapy With Japanese Subjects With Genotype 1 Chronic Hepatitis C (HCV) Virus Infection
Study Start Date : April 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Daclatasvir

Arm Intervention/treatment
Experimental: BMS-790052 + BMS-650032 Drug: BMS-790052
Tablets, Oral, 60 mg, daily, 24 weeks

Drug: BMS-650032
Tablets, Oral, 1200 mg, daily, 24 weeks

Primary Outcome Measures :
  1. Part 1: To assess safety and tolerability based on 4 weeks safety data, as measured by related serious adverse events (SAEs) and discontinuations due to related AEs [ Time Frame: Week 4 ]
  2. Part 2: To determine the proportion of subjects who achieve SVR12 (i.e., HCV RNA < 15 IU/mL at follow-up Week 12) [ Time Frame: Post-treatment Week 12 ]

Secondary Outcome Measures :
  1. The safety of co-administration of BMS-790052 + BMS-650032 as measured by the frequency of SAEs, discontinuations due to AEs, and Grade 3 - 4 laboratory abnormalities [ Time Frame: Weeks 4, 12, end of treatment and post-treatment Week 24 ]
  2. The proportion of subjects who achieve RVR (defined as HCV RNA < 15 IU/mL [ Time Frame: Week 4 ]
  3. The proportion of subjects with extended rapid virologic response (eRVR), defined as HCV RNA < 15 IU/mL [ Time Frame: at both Weeks 4 and 12 ]
  4. The proportion of subjects who achieve SVR24 (defined as HCV RNA < 15 IU/mL [ Time Frame: at follow-up Week 24 ]
  5. Resistant variants associated with clinical failure [ Time Frame: Weeks 4, 12, end of treatment and post-treatment Week 24 ]

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

Inclusion Criteria:

  • Subjects chronically infected with HCV Genotype 1
  • HCV RNA viral load of ≥ 10*5* IU/mL (100,000 IU/mL) at screening

Exclusion Criteria:

  • Subjects with evidence of liver cirrhosis
  • Evidence of HCC
  • Co-infection with hepatitis B virus, HIV

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 identifier (NCT number): NCT01051414

Local Institution
Hiroshima City, Hiroshima, Japan, 734-0037
Local Institution
Sapporo-Shi, Hokkaido, Japan, 060-0033
Local Institution
Kawasaki-Shi, Kanagawa, Japan, 2138587
Local Institution
Minato-Ku, Tokyo, Japan, 105-0001
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb Identifier: NCT01051414     History of Changes
Other Study ID Numbers: AI447-017
First Posted: January 18, 2010    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: September 2015

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