EUCTR2009-016560-36-IT
Active, not recruiting
Not Applicable
A long-term monitoring study to evaluate the persistence of direct acting antiviral (DAA) treatmentresistant mutations or the durability of sustained virological response (SVR) in patients treated with DAAcontaining regimens for chronic hepatitis C infection (CHC). - ND
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Hepatitis C
- Sponsor
- F. Hoffmann-La Roche Ltd
- Enrollment
- 650
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients who have participated in Roche DAA treatment protocol(s) for the treatment of CHC infection and have: \- Developed DAA\-associated resistant mutation(s) which persisted through to the last evaluation of drug resistance in the donor protocol(s); or \- Achieved SVR\-24, defined as undetectable HCV RNA as measured by the Roche COBAS TaqMan HCV Test (detection limit \= 15 IU/mL) \= 20 weeks after the last dose of study medication. Et al.
- •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) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •1\. Enrollment in another study for either research or treatment purposes. Patients may provide blood samples for a diagnostic study. 2\. Initiation of a treatment after participation in the donor protocol to which there is evidence of cross\-resistance to donor protocol DAA.
Outcomes
Primary Outcomes
Not specified
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