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OpenTrials
Completed

NCT Number: NCT01193361

Ph IIA Study (SOC +/- NS5B)

At least 1 dose of BMS-791325 can be identified which is safe, well tolerated, and efficacious when combined with peg-interferon alfa-2a (pegIFNα-2a)/ribavirin (RBV) for the treatment of treatment-naïve, chronically-infected hepatitis C virus (HCV) genotype 1 subjects

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Advanced Clinical Research Institute, Anaheim, California, United States

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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 as documented by: positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to Screening, and positive for HCV RNA and anti-HCV antibody at Screening
  • HCV RNA ≥ 10*5* IU/mL at Screening
  • Less than 4 weeks total prior therapy with an IFN formulation (ie, IFNα, pegIFNα-2a), or RBV and no exposure to IFN or RBV within 24 weeks of Randomization
  • Results of a biopsy obtained ≤ 24 months prior to Randomization showing no evidence of cirrhosis
  • Body Mass Index (BMI) of 18 to 35 kg/m², inclusive. BMI = weight (kg)/ [height (m)]² at Screening

Exclusion criteria

  • Liver transplant recipients
  • Documented or suspected HCC by imaging or liver biopsy
  • Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
  • History of chronic hepatitis B virus (HBV) as documented by HBV serologies (eg. HBsAg-seropositive). Patients with resolved HBV infection may participate (eg. HBsAb-seropositive)
  • Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment

Treatment and study plan

BMS-791325

Drug

Tablets, Oral, 75 mg, twice daily, 4-48 weeks depending on response

Placebo

Drug

Tablets, Oral, 0 mg, twice daily, 4-48 weeks depending on response

PEG-interferon alfa-2a

Drug

Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response

Other names: Pegasys

Ribavirin

Drug

Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response

Other names: Copegus

Primary outcomes

  1. Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)

    Time frame: Formal analysis at week 4 (and upon occurrence)

  2. Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)

    Time frame: Formal analysis at week 12 (and upon occurrence)

  3. Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)

    Time frame: Formal analysis at week 24 post treatment (and upon occurrence)

  4. Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)

    Time frame: Formal analysis at week 48 post treatment (and upon occurrence)

  5. Antiviral activity, as determined by the proportion subjects with eRVR

    Time frame: Week 4

  6. Antiviral activity, as determined by the proportion subjects with eRVR

    Time frame: Week 12

Secondary outcomes

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

    Time frame: Week 4

  2. Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA

    Time frame: Week 12

  3. Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up

    Time frame: Week 12

  4. Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up

    Time frame: Week 24

  5. Resistant HCV variants associated with virologic failure

    Time frame: End of treatment (Week 48) or upon early discontinuation

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 2A Study of BMS-791325 in Combination With Peg Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve Subjects With Chronic Hepatitis C Virus Genotype 1 Infection

Acronym: HEPCAT

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Sep 1, 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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