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

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alisporivir

Drug

Intervention of interest; follow-up after ALV-active study

Other names: DEB025, Debio 025, ALV

Primary outcomes

Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48

Time frame: up to 120 Weeks

Secondary outcomes

Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48.

Time frame: at Week 48

Note that the 24-week period between end of feeder study (SVR24) and first visit in this follow-up study is not counted in the 48 weeks, so this timepoint corresponds to 96 weeks (=24+24+48) after the last dose of alisporivir.

Sponsors and collaborators

Lead sponsor

Debiopharm International SA

Industry

Registry information

Official study title

A Multi-centre Long Term Follow-up Study to Assess the Durability of Sustained Virologic Response in Alisporivir-treated Chronic Hepatitis C Patients

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Apr 28, 2016
Registry last updated: Aug 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed