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Completed

NCT Number: NCT01051414

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

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

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Key information

Conditions

Hepatitis C Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Hiroshima, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-790052

Drug

Tablets, Oral, 60 mg, daily, 24 weeks

BMS-650032

Drug

Tablets, Oral, 1200 mg, daily, 24 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jan 18, 2010
Registry last updated
Oct 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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