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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)

Primary Purpose

Hepatitis C

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Peginterferon alfa 2a
Ribavirin
Placebo matching Daclatasvir
Daclatasvir
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    pegIFNα 2a + Ribavirin + Placebo

    pegIFNα 2a + Ribavirin + Daclatasvir

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    Proportion of Genotype 1 subjects with SVR24, defined as HCV RNA < Limit of quantification (LOQ) at follow-up Week 24 for each cohort

    Secondary Outcome Measures

    Proportion of Genotype (GT) 4 subjects with SVR24
    Proportion of GT 1 & 4 subjects who achieve HCV RNA < LOQ or undetectable
    Frequency of Serious Adverse Events (SAEs)/discontinuations due to Adverse Events (AEs)
    Discontinuations due to Adverse Events (AEs)
    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

    Full Information

    First Posted
    February 21, 2013
    Last Updated
    November 21, 2013
    Sponsor
    Bristol-Myers Squibb
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01797848
    Brief Title
    Efficacy and Safety Evaluation of a Treatment Consisting of Peg Interferon Alfa + Ribavirin + Daclatasvir in HCV Genotype 1 and 4 Treatment naïve Patients
    Acronym
    COMMAND-Asia
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2013
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    June 2014 (undefined)
    Primary Completion Date
    November 2016 (Anticipated)
    Study Completion Date
    November 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bristol-Myers Squibb

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    pegIFNα 2a + Ribavirin + Placebo
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    pegIFNα 2a + Ribavirin + Daclatasvir
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Peginterferon alfa 2a
    Other Intervention Name(s)
    Pegasys®
    Intervention Type
    Drug
    Intervention Name(s)
    Ribavirin
    Other Intervention Name(s)
    Copegus® (Taiwan, Korea and Singapore), Wei Lining (China)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo matching Daclatasvir
    Intervention Type
    Drug
    Intervention Name(s)
    Daclatasvir
    Other Intervention Name(s)
    BMS-790052-05
    Primary Outcome Measure Information:
    Title
    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
    Secondary Outcome Measure Information:
    Title
    Proportion of Genotype (GT) 4 subjects with SVR24
    Time Frame
    Week 24 post treatment follow up visit
    Title
    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)
    Title
    Frequency of Serious Adverse Events (SAEs)/discontinuations due to Adverse Events (AEs)
    Time Frame
    Up to 48 weeks plus 30 days
    Title
    Discontinuations due to Adverse Events (AEs)
    Time Frame
    Up to 48 weeks plus 7 days
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: Hemoglobin < 12 g/dL (females) or < 13 g/dL (males) Platelets < 90 x 1000000000 cells/L Absolute neutrophil count (ANC) < 1.5 × 1000000000 cells/L Total bilirubin ≥ 34 µmol/L (unless due to Gilbert's disease)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bristol-Myers Squibb
    Organizational Affiliation
    Bristol-Myers Squibb
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://www.bms.com/studyconnect/Pages/home.aspx
    Description
    BMS clinical trial educational resource

    Learn more about this trial

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

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