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

A multicenter, single-arm trial evaluating the safety and efficacy of DEB025/Alisporivir in combination with pegylated interferon-?2a and ribavirin (peg-IFN?2a/RBV) in protease inhibitor treatment failure patients with chronic hepatitis C genotype 1

ovartis Farmacéutica S.A0 sites173 target enrollmentFebruary 1, 2012
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ConditionsChronic hepatitis C genotype 1 protease inhibitor (PI) treatment failureMedDRA version: 14.1Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsCopegusPegasys

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic hepatitis C genotype 1 protease inhibitor (PI) treatment failure
Sponsor
ovartis Farmacéutica S.A
Enrollment
173
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 1, 2012
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
ovartis Farmacéutica S.A

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 44
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 44

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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