A 3-Year Follow-up Study in Subjects previously treated with Odalasvir and AL-335 With or Without Simeprevir for Hepatitis C Virus (HCV) Infection.

Phase 1

• Conditions: Chronic Hepatitis C virus infection.; MedDRA version: 20.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-002608-19-PL
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-18
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1. Subject was randomized to a regimen containing ODV + AL-335 ± SMV in a preceding Phase 2 or Phase 3 study (ie, parent study).
2. Subject received at least 1 dose of ODV + AL-335 ± SMV in the parent study.
3. Subject has completed the LPVPS (ie, the last post-therapy follow-up visit of the parent study) and has not passed 6 ±3 months after the LPVPS, as outlined in the TIME AND EVENTS SCHEDULE outlined in the study protocol
4. Subject has signed an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 52
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

1. Subject is currently enrolled or plans to enroll in another study with an investigational drug (including investigational vaccines) or an invasive investigational medical device between the LPVPS and Visit 6 of the present study (ie, 36 ±4 weeks after the LPVPS of the parent study).
2. Subject received antiviral or immunomodulating treatment, including therapeutic vaccines, for HCV infection between the LPVPS and the screening visit of the present study, or is planned to receive such treatment during the period of this follow-up study.
3.Subject is not able to adhere to the requirements of the follow-up study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified