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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Recruitment Status : Withdrawn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

Study Description
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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

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Peginterferon alfa 2a Drug: Ribavirin Drug: Placebo matching Daclatasvir Drug: Daclatasvir Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2014
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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

 Drug: Peginterferon alfa 2a
Other Name: Pegasys®

Drug: Ribavirin
Other Names:
  • Copegus® (Taiwan, Korea and Singapore)
  • Wei Lining (China)

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

 Drug: Peginterferon alfa 2a
Other Name: Pegasys®

Drug: Ribavirin
Other Names:
  • Copegus® (Taiwan, Korea and Singapore)
  • Wei Lining (China)

Drug: Daclatasvir
Other Name: BMS-790052-05


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Proportion of Genotype (GT) 4 subjects with SVR24 [ Time Frame: Week 24 post treatment follow up visit ]
  2. 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) ]
  3. Frequency of Serious Adverse Events (SAEs)/discontinuations due to Adverse Events (AEs) [ Time Frame: Up to 48 weeks plus 30 days ]
  4. Discontinuations due to Adverse Events (AEs) [ Time Frame: Up to 48 weeks plus 7 days ]
  5. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797848


Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01797848    
Other Study ID Numbers: AI444-047
First Posted: February 25, 2013    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
RNA Virus Infections
Blood-Borne Infections
 Communicable Diseases
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents