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

NCT03099135 | Terminated Phase 3

• 3 other identifiers: CR1083012016-002608-1964294178HPC3001
• Study Type: interventional
• Target: 24
• Locations: 4 countries
• Sites: 11

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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Maintaining Sustained Virologic Response (SVR) Until the End of the Long-Term Follow-Up

  Participants maintained SVR if HCV RNA less than (\<) lower limit of quantification (LLOQ) (Detected or Not Detected) per timepoint in this study.

  Up to 3 years

Secondary Outcomes (2)

• Percentage of Participants With Late Viral Relapse Among Participants who Achieved SVR at Last Post-Therapy Visit of Parent Study (LPVPS)

  Up to 3 years

• Liver Disease Status in All Participants who Achieved or did not Achieve SVR at LPVPS

  Up to 3 years

Study Arms (1)

Odalasvir and AL-335 With or Without Simeprevir

OTHER

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.

Drug: No Treatment

Interventions

No Treatment 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.

Odalasvir and AL-335 With or Without Simeprevir

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (11)

LAIR Centre

Vancouver, British Columbia, V5Z 1H2, Canada

Location

Vancouver Prostate Centre, Gordon and Leslie Diamond Health Care Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

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

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Vancouver ID Research and Care Centre Society

Vancouver, British Columbia, V6Z2C7, Canada

Location

PerCuro Clinical Research Ltd.

Victoria, British Columbia, V8V 3P9, Canada

Location

Auckland District Health Board

Auckland, 1142, New Zealand

Location

Christchurch Clinical Studies Trust

Christchurch, 8011, New Zealand

Location

Wojewodzki Szpital Specjalistyczny im. dr Wl. Bieganskiego

Lodz, 91-347, Poland

Location

Hepid Diagnostyka I Terapia Tomasiewicz Kiciak Lekarze Spolka Partnerska

Lublin, 20 884, Poland

Location

ID Clinic

Mysłowice, 41-400, Poland

Location

National University Hospital

Singapore, 119074, Singapore

Location

Related Links

• 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

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 4, 2017
• Study Start: April 10, 2017
• Primary Completion: February 1, 2018
• Study Completion: February 13, 2018
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

CA (5); PL (3); NZ (2); SG (1)