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Completed

NCT Number: NCT01718145

A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects

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

The purpose of this study is to compare the anti-viral activity of the co-administration of Asunaprevir (ASV) and Daclatasvir (DCV) to Telaprevir (TVR) included therapy in Japanese Hepatitis C virus (HCV) subjects

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Key information

Conditions

Hepatitis C Virus 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 3

Primary location

Local Institution, Nagoya, Aichi-ken, Japan

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About this study

Intervention Model: Parallel in the Naive cohort and Single group in the Relapser cohort

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 Ribonucleic acid (RNA) > 100,000 IU/mL at screening
  • Ages 20 to 70 years (for the Naive cohort), ages 20 to 75 years (for the Relapser cohort)
  • Treatment naive subjects to Interferon (IFN) based therapy
  • Subjects who had undetectable HCV RNA at end of treatment with prior exposure to an IFN-containing regimen, but HCV RNA detectable within 24 weeks of treatment follow-up

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

Daclatasvir

Drug

Asunaprevir

Drug

Ribavirin

Drug

pegIFNα-2b

Biological

Telaprevir

Drug

Primary outcomes

  1. Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the naive cohort

    Time frame: After 12 weeks of the last dose

    • SVR12 = Sustained virologic response at post-treatment Week 12
    • LLOQ = Lower Limit of quantitation

Secondary outcomes

  1. Proportion of subjects with hemoglobin < 10g/dL

    Time frame: First 12 weeks of treatment

  2. Proportion of subjects with rash-related dermatologic events

    Time frame: First 12 weeks of treatment

  3. Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the naive cohort

    Time frame: At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12; EOT (up to 24 weeks), post-treatment Week 4 and post-treatment Week 24

    EOT = End of treatment

  4. Proportion of subjects with HCV RNA target not detected in the naive cohort

    Time frame: At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 4, post-treatment Week 12 and post-treatment Week 24

    eRVR = Extended rapid virologic response

  5. Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the relapser cohort

    Time frame: At post-treatment Week 12

  6. Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the relapser cohort

    Time frame: At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12; EOT (up to 24 weeks), post-treatment Week 4 and Week 24

  7. Proportion of subjects with HCV RNA target not detected in the relapser cohort

    Time frame: At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 4, post-treatment Week 12 and post-treatment Week 24

  8. On treatment safety, as measured by the frequency of Severe adverse events (SAEs), discontinuation and dose modification/interruption due to Adverse events (AEs), Grade 3-4 abnormalities observed from clinical laboratory tests for each treatment group

    Time frame: End of treatment (24 weeks) plus 7days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 3, Comparative Study of Asunaprevir and Daclatasvir (DUAL) Combination Therapy Versus Telaprevir Therapy in Japanese Genotype 1b Chronic Hepatitis C IFN Eligible-naive Subjects With a Single Arm Assessment of DUAL Therapy in IFN-therapy Relapsers

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Oct 31, 2012
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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