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Efficacy and Safety Evaluation of a Treatment Consisting of Peg Interferon Alfa + Ribavirin + Daclatasvir in HCV Genotype 1 and 4 Treatment naïve Patients (COMMAND-Asia)

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ClinicalTrials.gov Identifier: NCT01797848
Recruitment Status : Withdrawn
First Posted : February 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE February 21, 2013
First Posted Date  ICMJE February 25, 2013
Last Update Posted Date November 25, 2013
Study Start Date  ICMJE June 2014
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2013)
Proportion of Genotype 1 subjects with SVR24, defined as HCV RNA < Limit of quantification (LOQ) at follow-up Week 24 for each cohort [ Time Frame: Week 24 post treatment follow up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2013)
  • Proportion of Genotype (GT) 4 subjects with SVR24 [ Time Frame: Week 24 post treatment follow up visit ]
  • Proportion of GT 1 & 4 subjects who achieve HCV RNA < LOQ or undetectable [ Time Frame: Week 24 post treatment follow up visit and Week 48 post treatment follow up visit for subjects who achieve Virologic response [VR] (4&12) ]
  • Frequency of Serious Adverse Events (SAEs)/discontinuations due to Adverse Events (AEs) [ Time Frame: Up to 48 weeks plus 30 days ]
  • Discontinuations due to Adverse Events (AEs) [ Time Frame: Up to 48 weeks plus 7 days ]
  • Proportion of subjects with Sustained Virologic Response at follow up week 12 (SVR12) or SVR24 by rs12979860 Single nucleotide polymorphism (SNP) in the IL28B gene [ Time Frame: Up to 72 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Evaluation of a Treatment Consisting of Peg Interferon Alfa + Ribavirin + Daclatasvir in HCV Genotype 1 and 4 Treatment naïve Patients
Official Title  ICMJE A Phase 3 Randomized, Double Blind, Multi-National Evaluation of Daclatasvir in Combination With Peg Interferon Alfa-2a and Ribavirin in Treatment-Naive Subjects With Chronic Hepatitis C Genotypes 1 and 4
Brief Summary The purpose of this study is to determine whether 24 week treatment with the Daclatasvir (DCV) in combination with Pegylated-interferon alfa 2a (pegIFNα-2a) and Ribavirin (RBV) is safe and demonstrates rate of Sustained Virologic Response at follow up week 24 (SVR24) (defined as undetectable HCV RNA at post-treatment Week 24) that are non-inferior to 48 weeks of the dual combination therapy of pegIFNα-2a/RBV in a majority of study subjects
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • Drug: Peginterferon alfa 2a
    Other Name: Pegasys®
  • Drug: Ribavirin
    Other Names:
    • Copegus® (Taiwan, Korea and Singapore)
    • Wei Lining (China)
  • Drug: Placebo matching Daclatasvir
  • Drug: Daclatasvir
    Other Name: BMS-790052-05
Study Arms  ICMJE
  • Experimental: pegIFNα 2a + Ribavirin + Placebo

    pegIFNα 2a 180 µg, Solution for injection, Subcutaneous, Once weekly, 48 weeks

    Ribavirin 200 mg Tablets, by mouth, 400-600mg AM, 600 mg PM, 48 weeks

    Placebo 0 mg Tablets, by mouth, Once daily, 24 weeks

    Interventions:
    • Drug: Peginterferon alfa 2a
    • Drug: Ribavirin
    • Drug: Placebo matching Daclatasvir
  • Experimental: pegIFNα 2a + Ribavirin + Daclatasvir

    pegIFNα 2a 180 µg, Solution for injection, Subcutaneous, Once weekly, 24 or 48 weeks depending on response

    Ribavirin 1000-1200 mg Tablets, by mouth, 400-600mg AM, 600 mg PM, 24 or 48 weeks depending on response

    Daclatasvir 60 mg Tablets, by mouth, Once daily, 24 weeks

    Interventions:
    • Drug: Peginterferon alfa 2a
    • Drug: Ribavirin
    • Drug: Daclatasvir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 21, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2013)
885
Estimated Study Completion Date  ICMJE November 2016
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients chronically infected with Hepatitis C virus (HCV) GT 1 or 4
  • HCV RNA viral load ≥ 10,000 IU/mL
  • Naïve to prior treatment with any interferon formulation, Ribavirin (RBV) or HCV direct antiviral agent
  • Patients with compensated cirrhosis are permitted

Exclusion Criteria:

  • Infected with HCV other than GT 1 or 4
  • Evidence of decompensated liver disease
  • Documented or suspected Hepatocellular carcinoma (HCC) as evidenced by previously obtained imaging studies or liver biopsy
  • Evidence of a medical condition contributing to chronic liver disease other than HCV
  • History of chronic Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV)
  • Current or know history of cancer (except in situ carcinoma of cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
  • Laboratory values:

    1. Hemoglobin < 12 g/dL (females) or < 13 g/dL (males)
    2. Platelets < 90 x 1000000000 cells/L
    3. Absolute neutrophil count (ANC) < 1.5 × 1000000000 cells/L
    4. Total bilirubin ≥ 34 µmol/L (unless due to Gilbert's disease)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Taiwan
 
Administrative Information
NCT Number  ICMJE NCT01797848
Other Study ID Numbers  ICMJE AI444-047
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bristol-Myers Squibb
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bristol-Myers Squibb
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date November 2013

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