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Clinical Trials/EUCTR2009-016560-36-DE
EUCTR2009-016560-36-DE
Active, not recruiting
Phase 1

A long-term monitoring study to evaluate the persistence of direct acting antiviral (DAA) treatment-resistant mutations or the durability of sustained virological response (SVR) in patients treated with DAA-containing regimens for chronic hepatitis C infection (CHC)

F. Hoffmann-La Roche Ltd0 sites650 target enrollmentJune 18, 2010
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ConditionsChronic Hepatitis CMedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsPegasysCopegus

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Chronic Hepatitis C
Sponsor
F. Hoffmann-La Roche Ltd
Enrollment
650
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 18, 2010
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients who have participated in Roche DAA treatment protocol(s) for the treatment of CHC infection and have: • Developed DAA\-associated resistance mutation(s) which persisted through to the last evaluation of drug resistance in the donor protocols, or achieved only a partial viral response or experienced viral breakthrough while on mericitabine treatment (see definitions in Appendix 1\) not associated with selection of S282T resistance mutations or any newly identified mericitabine resistance mutation(s), or • Achieved SVR\-24, as defined by each donor study protocol, measured by the Roche COBAS TaqMan HCV Test \= 20 weeks after the last dose of study medication 2\. Willingness to give written informed consent and willingness to participate in and comply with the study requirements
  • •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 640
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 10

Exclusion Criteria

  • •Patients with any of the following will not be eligible for participation:
  • •1\. Patients participating in DAA resistance monitoring: initiation of treatment for
  • •CHC after participation in the donor protocol (except prescribed PEG\-IFN/RBV
  • •and/or registered DAAs without evidence of cross\-resistance to donor protocol
  • •2\. Patients participating in DAA SVR durability: treatment with any anti HCV therapy (perceived or known anti\-HCV activity) since establishing SVR in the donor study

Outcomes

Primary Outcomes

Not specified

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