Status:
TERMINATED
An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Brief Summary
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 chro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
734 Patients enrolled
Trial Details
Trial ID
NCT01168856
Start Date
September 1 2010
End Date
April 1 2015
Last Update
March 11 2016
Active Locations (126)
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1
La Jolla, California, United States, 92037-1030
2
Long Beach, California, United States, 90822
3
Sacramento, California, United States, 95817
4
Sacramento, California, United States, 95825