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Clinical Trials/EUCTR2011-004237-14-GB
EUCTR2011-004237-14-GBActive, not recruitingPhase 1

A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared with Telaprevir in Combination with Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Patients with Chronic Hepatitis-C Revised Protocol 02 incorporating protocol amendment 03 (version 1.0 dated 22-Jan-13). + Pharmacogenetics Blood Sample Amendment 01 (version 1.0 dated 23-Nov-11) + Administrative Letter 01 Site Specific dated 27-Mar-2012 - COMMAND-3

Bristol-Myers Squibb International Corporation0 sites793 target enrollmentStarted: February 14, 2012Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
793
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •- Subjects chronically infected with HCV genotype 1a or 1b
  • •-HCV RNA viral load =10,000 IU/mL
  • •- No prior treatment including but not limited to interferon, ribavirin and direct-acting antivirals
  • •- if no prior history of cirrhosis
  • •liver biopsy within 3 years or Fibroscan® within 1 year
  • •-Body Mass Index (BMI) of 18 to 35 kg/m2
  • •-Negative for HIV and Hepatitis B
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 810
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

  • •- Evidence of decompensated liver disease
  • •- Evidence of medical condition contributing to chronic liver disease other than HCV

Investigators

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