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)

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• Recruitment Status: Withdrawn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

Tracking Information

• First Submitted Date: February 21, 2013
• First Posted Date: February 25, 2013
• Last Update Posted Date: November 25, 2013
• Study Start Date: June 2014
• Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Hepatitis C

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: November 21, 2013): 0
• Original Estimated Enrollment (submitted: February 21, 2013): 885
• Estimated Study Completion Date: November 2016
• Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

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:

  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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT01797848
• Other Study ID Numbers: AI444-047
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Bristol-Myers Squibb
• Original Responsible Party: Same as current
• Current Study Sponsor: Bristol-Myers Squibb
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Bristol-Myers Squibb
• Verification Date: November 2013