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Clinical Trials/EUCTR2011-004237-14-IT
EUCTR2011-004237-14-IT
Active, not recruiting
Not Applicable

A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared withTelaprevir in Combination with Peg-Interferon Alfa-2a and Ribavirin inTreatment-Naive Patients with Chronic Hepatitis-C - COMMAND-3

BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO0 sites900 target enrollmentFebruary 21, 2012
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO
Enrollment
900
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 21, 2012
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Subjects chronically infected with HCV genotype 1
  • •\- 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: 0

Exclusion Criteria

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

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Study comparing BMS-790052 (daclatasvir) to telaprevir combined with peginterferon-alfa-2a and ribavirin in untreated hepatitis C patientsChronic Hepatitis CMedDRA version: 14.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
EUCTR2011-004237-14-GBBristol-Myers Squibb International Corporation793
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Study comparing BMS-790052 (daclatasvir) to telaprevir combined with peginterferon-alfa-2a and ribavirin in untreated hepatitis C patientsChronic Hepatitis CMedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
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EUCTR2011-004237-14-ESBristol-Myers Squibb International Corporation900
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Study comparing BMS-790052 (daclatasvir) to telaprevir combined with peginterferon-alfa-2a and ribavirin in untreated hepatitis C patientsChronic Hepatitis CMedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
EUCTR2011-004237-14-DEBristol-Myers Squibb International Corporation900
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Study comparing BMS-790052 (daclatasvir) to telaprevir combined with peginterferon-alfa-2a and ribavirin in untreated hepatitis C patients
EUCTR2011-004237-14-ATBristol-Myers Squibb International Corporation900