Chronic Hepatitis C virus infection. MedDRA version: 19.1 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Pharmaceutical Form:
INN or Proposed INN: Simeprevir
CAS Number: 923604-59-5
Other descriptive name: SIMEPREVIR
Pharmaceutical Form:
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
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 237 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 13
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the durability of SVR in subjects who achieved SVR at last post-therapy visit of parent study (LPVPS).; Secondary Objective: • The incidence of late viral relapse for subjects who achieved SVR at LPVPS. • Liver disease status for all enrolled subjects. ;Primary end point(s): The primary efficacy endpoint is the proportion (%) of subjects maintaining SVR until the end of the long-term follow-up;Timepoint(s) of evaluation of this end point: until the end of the long-term follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -The proportion of subjects with late viral relapse among subjects who achieved SVR at LPVPS. -Liver disease status in all subjects who achieved or who did not achieve SVR at LPVPS. ;Timepoint(s) of evaluation of this end point: until the end of the long-term follow-up | — |
Countries
Belgium, Canada, Germany, Italy, New Zealand, Poland, Singapore, Spain
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV (Janssen Biologics)
Outcome results
None listed