Long Term Follow-up Study to Assess Durability of Sustained Virologic Response in Alisporivir-treated Hepatitis C Patients

Debiopharm logo

Debiopharm

Status and phase

Completed
Phase 3

Conditions

Hepatitis C

Treatments

Drug: Alisporivir

Study type

Interventional

Funder types

Industry

Identifiers

NCT02753699
2011-006131-38 (EudraCT Number)
CDEB025A2312

Details and patient eligibility

About

The purpose of this study is to follow-up with participants from feeder studies who achieved sustained virologic response (SVR) over 24 hours posttreatment (SVR24), to assess durability of SVR, and to assess the changes in liver disease, development of hepatocellular carcinoma and post-treatment safety over time. Participants enter this study from feeder studies CDEB025A2210 (NCT01183169), CDEB025A2301 (NCT01318694), and CDEB025A2211 (NCT01215643). They return to the site for up to 48 weeks with a maximum of 3 visits. No treatment is involved.

Enrollment

723 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Provides written informed consent before any assessment is performed
  • Is male or female aged ≥18
  • Has previously completed a Novartis-sponsored hepatitis C study and received alisporivir
  • Has achieved SVR24
  • Is able to comply with the visit schedule

Exclusion criteria

  • Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer.
  • Use or planned use to start a new course of hepatitis C therapy.
  • No additional exclusions are to be applied by the Investigator, in order to ensure that the study population is representative of all eligible patients.

Trial design

723 participants in 3 patient groups

From Study 2210
Experimental group
Description:
All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study.
Treatment:
Drug: Alisporivir
From Study 2301
Experimental group
Description:
All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study.
Treatment:
Drug: Alisporivir
From Study 2211
Experimental group
Description:
All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study.
Treatment:
Drug: Alisporivir

Trial contacts and locations

119

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems