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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01497834
First received: December 2, 2011
Last updated: September 18, 2014
Last verified: September 2014

December 2, 2011
September 18, 2014
January 2012
April 2013   (final data collection date for primary outcome measure)
Antiviral activity, as determined by the proportion of subjects with SVR24 [ Time Frame: After 24 weeks of the last dose ] [ Designated as safety issue: No ]
SVR24 - sustained virologic response at follow-up Week 24 (after end of treatment)
Same as current
Complete list of historical versions of study NCT01497834 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Antiviral activity, as determined by the proportion of subjects who achieve Hepatitis C virus (HCV) ribonucleic acid (RNA) below limit of quantitation (LOQ) [ Time Frame: Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; End of treatment (EOT), or post treatment Week 12 ] [ Designated as safety issue: No ]
  • Antiviral activity, as determined by the proportion of subjects who achieve undetectable HCV RNA [ 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 ] [ Designated as safety issue: No ]
  • Safety, as measured by the frequency of severe 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients
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

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

Not Provided
Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C
  • Drug: BMS-790052 (Daclatasvir)
    Tablets, Oral, 60mg, Once daily, 24 weeks
  • Drug: BMS-650032 (Asunaprevir)
    Capsules, Oral, 100mg, Twice daily, 24 weeks
Experimental: Daclatasvir + Asunaprevir
Interventions:
  • Drug: BMS-790052 (Daclatasvir)
  • Drug: BMS-650032 (Asunaprevir)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
224
June 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01497834
AI447-026
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP