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
  Purpose

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


Condition Intervention Phase
Hepatitis C Infection
Drug: BMS-790052
Drug: BMS-650032
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 43
Study Start Date: April 2010
Study Completion Date: May 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01051414

Locations
Japan
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
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01051414     History of Changes
Other Study ID Numbers: AI447-017
Study First Received: January 15, 2010
Last Updated: May 21, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Infection
Communicable Diseases
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 September 18, 2014