Last updated on February 2018

A Long Term Follow-up Study in Participants Treated in a Preceding Phase 2 or 3 Study With a Regimen Containing Odalasvir and AL-335 With or Without Simeprevir for the Treatment of Hepatitis C Virus (HCV) Infection


Brief description of study

The main purpose of this study is to evaluate the durability of Sustained virologic response (SVR) in participants who achieved SVR at last post-therapy visit of parent studies (LPVPS) with NCT Numbers NCT02569710 and NCT02765490.

Detailed Study Description

This multicentre study will not provide any study treatment but collect follow-up data for up to 3 years to assess the long term durability of SVR achieved in one of the parent studies [phase 2 or 3 with AL-335 and Odalasvir (ODV) with or without Simeprevir (SMV]. In addition participants who failed to achieve an SVR in the parent study can be enrolled to assess the presence of resistance associated substitutions (RAS) and their persistance over time. It is expected that the vast majority of approximately 250 participants will enrolled in the study. Safety parameters and Liver disease status will be assessed in all participants over time.

Clinical Study Identifier: NCT03099135

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LAIR Centre
Vancouver, BC Canada
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Vancouver Prostate Centre, Gordon and Leslie Diamond Health Care Centre
Vancouver, BC Canada
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GI Research Institute (G.I.R.I.)
Vancouver, BC Canada
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Vancouver ID Research and Care Centre Society
Vancouver, BC Canada
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PerCuro Clinical Research Ltd.
Victoria, BC Canada
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Toronto Liver Centre
Toronto, ON Canada
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Toronto Digestive Disease Associates Inc
Vaughan, ON Canada
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Clinique OPUS Inc
Monteral, QC Canada
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Chronic Viral Illness Service - McGill University Health Centre
Montreal, QC Canada
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Auckland District Health Board
Auckland, New Zealand
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Christchurch Clinical Studies Trust
Christchurch, New Zealand
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Wojewodzki Szpital Specjalistyczny im. dr Wl. Bieganskiego
Lodz, Poland
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Hepid Diagnostyka I Terapia Tomasiewicz, Kiciak - Lekarze Sp ka Partnerska
Lublin, Poland
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