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An Anti-viral Combination Study With Japanese Hepatitis C Infection (HCV) Subject
This study is ongoing, but not recruiting participants.

First Received on January 15, 2010.   Last Updated on February 2, 2012   History of Changes
Sponsor: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01051414
  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 II

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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C
U.S. FDA Resources

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 ]

Estimated Enrollment: 40
Study Start Date: April 2010
Estimated 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
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:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01051414     History of Changes
Other Study ID Numbers: AI447-017
Study First Received: January 15, 2010
Last Updated: February 2, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
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 February 09, 2012



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