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Clinical Trials/EUCTR2011-005446-35-ES
EUCTR2011-005446-35-ES
Active, not recruiting
Not Applicable

A Phase 3 Study with Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-Naive Subjects with Chronic Hepatitis C Genotype 1b Infection.+ Pharmacogenetics Blood Sample Amendment Number 01-Site Specific (version 1.0, dated 13-Mar-2012) - Hallmark DUA

Bristol-Myers Squibb International Corporation0 sites1,100 target enrollmentMay 29, 2012
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DrugsPegasysCopegus

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Bristol-Myers Squibb International Corporation
Enrollment
1100
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 29, 2012
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •? Males and females, ? 18 years of age;
  • •? HCV Genotype 1b who previously failed treatment with peginterferon alfa and ribavirin, classified as previous null or partial responders based on previous therapy, OR intolerant or ineligible to P/R due to neutropenia, anemia, depression or thrombocytopenia with cirrhosis, OR treatment naive;
  • •? HCV RNA ? 104 IU/mL (10,000 IU/mL);
  • •? Seronegative for HIV and HBsAg;
  • •? Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population).
  • •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 900
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •? Prior treatment of HCV with HCV direct acting antiviral (DAA);
  • •? Evidence of a medical condition contributing to chronic liver disease other than HCV;
  • •? Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy;
  • •? Diagnosed or suspected hepatocellular carcinoma or other malignancies;
  • •? Uncontrolled diabetes or hypertension;

Outcomes

Primary Outcomes

Not specified

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