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Completed

NCT Number: NCT01030432

Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin

The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).

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Key information

Conditions

Hepatitis C Virus 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

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Buenos Aires, Argentina

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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 (Phase 2a and Phase 2b)
  • Subjects chronically infected with HCV genotype 4 (Phase 2b only)
  • HCV RNA viral load of ≥ 10*5* IU/mL at screening
  • BMI of 18 - 35 kg/m² at screening

Exclusion criteria

  • Cirrhosis (Phase 2a only)
  • Decompensated cirrhosis (Phase 2b)
  • Co-infection with HBV or HIV
  • Hepatocellular carcinoma
  • Prior treatment with anti-HCV drugs

Treatment and study plan

BMS-650032

Drug

Tablets, Oral, 200 mg, Twice Daily, 48 weeks

Placebo

Drug

Tablets, Oral, 0 mg, twice daily, 48 weeks

Other names: Pegasys

Peginterferon alfa-2a

Drug

Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks

Other names: Pegasys

Ribavirin

Drug

Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks

Other names: Copegus

Primary outcomes

  1. Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs

    Time frame: 12 weeks after first dose

  2. Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA

    Time frame: Week 4

  3. Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA

    Time frame: Week 12

  4. Phase 2b only: Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA

    Time frame: at follow-up Week 24

Secondary outcomes

  1. Proportion of HCV genotype 1 subjects with rapid virologic response (RVR), defined as undetectable HCV RNA at Week 4

    Time frame: Week 4

  2. Proportion of HCV genotype 1 subjects with complete early rapid virologic response (eEVR), defined as undetectable HCV RNA at Week 12 (Stage 2 only)

    Time frame: at Week 12 (Stage 2 only)

  3. Proportion of HCV genotype 1 subjects with early virologic response (EVR) defined as ≥2 log10 decrease in HCV RNA from baseline at Week 12 (Stage 1 only)

    Time frame: Week 12 (Stage 1 only)

  4. Proportion of HCV genotype 1 subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA at follow-up Week 12

    Time frame: follow-up Week 12

  5. Proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24) defined as undetectable HCV RNA at follow-up Week 24 (Stage 1 only)

    Time frame: follow-up Week 24 (Stage 1 only)

  6. Resistant variants associated with virologic failure

    Time frame: 48 weeks after last dose

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 2a/2b Study of BMS-650032 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotypes 1 and 4 Chronic Hepatitis C Infection

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 11, 2009
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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