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Completed

NCT Number: NCT01497834

A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients

The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subjects.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis 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 3

Primary location

Local Institution, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chronic HCV-1b infected patient
  • HCV RNA viral load of ≥ 100,000 IU/mL at screening
  • Ages 20 to 75 years
  • Non-responder to Interferon plus Ribavirin therapy
  • Patient who has been excluded from interferon/ribavirin therapy or intolerant for Interferon/Ribavirin therapy

Exclusion criteria

Patients who have -

  • Hepatocellular carcinoma
  • Co-infection with Hepatitis B virus (HBV) or Human Immunodeficiency Virus (HIV)
  • Severe or uncontrollable complication

Treatment and study plan

BMS-790052 (Daclatasvir)

Drug

Tablets, Oral, 60mg, Once daily, 24 weeks

BMS-650032 (Asunaprevir)

Drug

Capsules, Oral, 100mg, Twice daily, 24 weeks

Primary outcomes

  1. Antiviral activity, as determined by the proportion of subjects with SVR24

    Time frame: After 24 weeks of the last dose

    SVR24 - sustained virologic response at follow-up Week 24 (after end of treatment)

Secondary outcomes

  1. Antiviral activity, as determined by the proportion of subjects who achieve Hepatitis C virus (HCV) ribonucleic acid (RNA) below lower limit of quantitation (LLOQ) target detected or not detected

    Time frame: Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; End of treatment (EOT), or post treatment Week 12

  2. Antiviral activity, as determined by the proportion of subjects who achieve HCV RNA below LLOQ, target not detected

    Time frame: Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; EOT, or post treatment Week 12, post treatment Week 24

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

    Time frame: End of treatment plus 7 days

  4. Proportion of subjects with SVR24 by IL28B status [CC, CT, or TT genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNP)]

    Time frame: Follow-up Week 24

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 3 Japanese Study of BMS-790052 Plus BMS-650032 Combination Therapy in Chronic Hepatitis C Genotype 1b Infected Subjects Who Are Non Response to Interferon Plus Ribavirin and Interferon Based Therapy Ineligible Naive/Intolerant

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 23, 2011
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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