Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hepatitis C
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2017-04-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Percentage of Participants Maintaining Sustained Virologic Response (SVR) Until the End of the Long-Term Follow-Up
timeFrame: Up to 3 years
Secondary outcomes:
measure: Percentage of Participants With Late Viral Relapse Among Participants who Achieved SVR at Last Post-Therapy Visit of Parent Study (LPVPS)
timeFrame: Up to 3 years
measure: Liver Disease Status in All Participants who Achieved or did not Achieve SVR at LPVPS
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: LAIR Centre
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver Prostate Centre, Gordon and Leslie Diamond Health Care Centre
state: British Columbia
city: Vancouver
country: Canada
facility: GI Research Institute (G.I.R.I.)
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver ID Research and Care Centre Society
state: British Columbia
city: Victoria
country: Canada
facility: PerCuro Clinical Research Ltd.
state: British Columbia
city: Auckland
country: New Zealand
facility: Auckland District Health Board
city: Christchurch
country: New Zealand
facility: Christchurch Clinical Studies Trust
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. dr Wl. Bieganskiego
city: Lublin
country: Poland
facility: Hepid Diagnostyka I Terapia Tomasiewicz Kiciak Lekarze Spolka Partnerska
city: Myslowice
country: Poland
facility: ID Clinic
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: