NCT01168856

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

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 (CHC)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 734 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Hepatitis C, Chronic

Timeline

• Start date: 2010-09-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2010-07-23
• Last updated: 2016-03-11
• Results posted: 2016-03-11

Locations

126 sites across 15 countries: United States, Australia, Austria, Brazil, Canada, France, Germany, Italy, Mexico, New Zealand, Poland, Puerto Rico, Slovakia, Spain, United Kingdom