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

Stopped early

Conditions studied: Hepatitis C, Chronic

In brief

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.

Key facts

Study ID

NCT01168856

Run by

Hoffmann-La Roche

People needed

734

Starts

2010-09-01

Expected to finish

2015-04-01

Last updated by the study team

2016-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Long Beach, California, United States
• Study site — Sacramento, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Englewood, Colorado, United States
• Study site — Bradenton, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Decatur, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Kansas City, Kansas, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Detroit, Michigan, United States
• Study site — Kansas City, Missouri, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — Hillsborough, New Jersey, United States
• Study site — Newark, New Jersey, United States
• Study site — Manhasset, New York, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — La Jolla, California, United States

Full record on ClinicalTrials.gov

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