View Clinical Trial (Medical Research Study)

A Long-term Monitoring Study to Evaluate the Persistence of Direct Antiviral (DAA) Treatment Resistant Mutations or the Durability of Sustained Virological Response (SVR) in Patients Treated With DAA Containing Regimens for Chronic Hepatitis C Infections

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Conditions:		Hepatitis C, Chronic
Purpose:		This observational long-term follow-up study will assess the persistence of direct acting antiviral (DAA) resistant mutations and the durability of sustained virological response in patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol. Up to 5 scheduled monitoring visits for blood sampling during an observational period of up to 36 months.
Study Summary:
Criteria:		Inclusion Criteria: - adult patients, >/=18 years of age - chronic hepatitis C - participation in Roche DAA treatment protocol for CHC infection - DAA-associated resistant mutations persisting through to last evaluation in donor protocol , or partial viral response or viral load rebound while on RO5024048 treatment, or sustained virological response >/= 20 weeks after last dose of study medication in donor study Exclusion Criteria: - For patients participating in DAA resistance monitoring: Initiation of treatment after participation in the donor protocol for which there is evidence of cross-resistance to donor protocol DAA - For patients participating in DAA SVR durability: Treatment with any anti-HVC therapy since establishing SVR in the donor study
NCT ID:		NCT01168856
Primary Contact:		Study Director Clinical Trials Hoffmann-La Roche Please reference Study ID Number: NV22688 Phone: 888-662-6728 (U.S. Only) Email: genentechclinicaltrials@druginfo.com
Backup Contact:		N/A
Location Contact:		Marietta, Georgia 30060 United States There is no listed contact information for this specific location. Site Status: Recruiting

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