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Clinical Trials/EUCTR2011-004653-31-DE
EUCTR2011-004653-31-DE
Active, not recruiting
Not Applicable

A multicenter, single-arm trial evaluating the safety and efficacy of DEB025/Alisporivir in combination with pegylated interferon-a2a and ribavirin (peg-IFNa2a/RBV) in protease inhibitor treatment failure patients with chronic hepatitis C genotype 1

ovartis Pharma Services AG0 sites173 target enrollmentDecember 27, 2011
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DrugsCopegusPegasys

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
ovartis Pharma Services AG
Enrollment
173
Status
Active, not recruiting
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 27, 2011
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.HCV GT1 patients with previous PI treatment failure.
  • •2\.Timing of the PI treatment: The minimum time from the last dose of previous PI treatment to the first dose of study medication is three months.
  • •3\.Diagnosed Chronic hepatitis C virus infection
  • •4\.Infection with HCV genotype 1
  • •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
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •1\.Use of other investigational drugs at the time of enrollment
  • •2\.History of hypersensitivity to any pegIFN or RBV
  • •3\.Any null non\-responders to prior pegIFN/RBV treatment
  • •Other protocol\-defined inclusion/exclusion criteria may apply.

Outcomes

Primary Outcomes

Not specified

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