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

NCT ID: NCT03099135

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-10
• Study Completion Date: 2018-02-13

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Odalasvir and AL-335 With or Without Simeprevir

Participants who completed the LPVPS (Phase 2 or Phase 3 study), in which they received a regimen containing Odalasvir and AL-335 With or Without Simeprevir for the treatment of HCV infection, and who agree to participate in this follow-up study will be assessed for durability of SVR, incidence of late viral relapse, presence and long term-persistence of resistance associated substitutions (RAS) and liver disease status.

Group Type: OTHER

No Treatment

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participant was randomized to a regimen containing Odalasvir (ODV) with AL-335 with or without Simeprevir in a preceding Phase 2 or Phase 3 study (parent study)
• Participant received at least 1 dose of ODV with AL-335 with or without SMV in the parent study
• Participant has completed the last post-therapy follow-up visit of the parent study ( LPVPS) and has not passed the screening period of 6 + 3 months after the LPVPS
• Participant has signed an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study

Exclusion Criteria

• Participant 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 (36 months (+/-) 4 weeks after the LPVPS of the parent study)
• Participant 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
• Participant is not able to adhere to the requirements of the follow-up study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

LAIR Centre

Vancouver, British Columbia, Canada

Vancouver Prostate Centre, Gordon and Leslie Diamond Health Care Centre

Vancouver, British Columbia, Canada

GI Research Institute (G.I.R.I.)

Vancouver, British Columbia, Canada

Vancouver ID Research and Care Centre Society

Vancouver, British Columbia, Canada

PerCuro Clinical Research Ltd.

Victoria, British Columbia, Canada

Auckland District Health Board

Auckland, , New Zealand

Christchurch Clinical Studies Trust

Christchurch, , New Zealand

Wojewodzki Szpital Specjalistyczny im. dr Wl. Bieganskiego

Lodz, , Poland

Hepid Diagnostyka I Terapia Tomasiewicz Kiciak Lekarze Spolka Partnerska

Lublin, , Poland

ID Clinic

Mysłowice, , Poland

National University Hospital

Singapore, , Singapore

Countries

Canada; New Zealand; Poland; Singapore

Related Links

https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-002608-19/results

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

Other Identifiers

2016-002608-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

64294178HPC3001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108301

Identifier Type: -

Identifier Source: org_study_id