NCT03099135

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

A Prospective 3-Year Follow-up Study in Subjects 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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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 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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	No Treatment	No treatment will be given tp participants during this follow-up study of previous phase II and Phase III in which they have received Odalavir and AL-335 with or without Simeprevir.

Timeline

• Start date: 2017-04-10
• Primary completion: 2018-02-01
• Completion: 2018-02-13
• First posted: 2017-04-04
• Last updated: 2025-02-03

Locations

11 sites across 4 countries: Canada, New Zealand, Poland, Singapore