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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01051414
First received: January 15, 2010
Last updated: May 21, 2013
Last verified: May 2013

January 15, 2010
May 21, 2013
April 2010
September 2011   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01051414 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • The proportion of subjects who achieve RVR (defined as HCV RNA < 15 IU/mL [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • The proportion of subjects who achieve SVR24 (defined as HCV RNA < 15 IU/mL [ Time Frame: at follow-up Week 24 ] [ Designated as safety issue: Yes ]
  • Resistant variants associated with clinical failure [ Time Frame: Weeks 4, 12, end of treatment and post-treatment Week 24 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
An Anti-viral Combination Study With Japanese Hepatitis C Infection (HCV) Subject
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

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

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C Infection
  • Drug: BMS-790052
    Tablets, Oral, 60 mg, daily, 24 weeks
  • Drug: BMS-650032
    Tablets, Oral, 1200 mg, daily, 24 weeks
Experimental: BMS-790052 + BMS-650032
Interventions:
  • Drug: BMS-790052
  • Drug: BMS-650032

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
May 2012
September 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01051414
AI447-017
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP