Follow-Up clinical trial in patients who have previously received test product RG-101 for assessment of long term safety and efficacy

Phase 1

• Conditions: Hepatitis C Patients; MedDRA version: 19.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 19.0Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 19.0Level: LLTClassification code 10019761Term: Hepatitis cytomegalovirusSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 19.0Level: LLTClassification code 10057394Term: Hepatitis C positiveSystem Organ Class: 100000004848; MedDRA version: 19.0Level: LLTClassification code 10019760Term: Hepatitis CMVSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 19.0Level: LLTClassification code 10047457Term: Viral hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-002069-77-HU
• Lead Sponsor: Regulus Therapeutics Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-18
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1.Previously received at least one dose of RG-101 in a Regulus sponsored clinical study
2.Able and willing to adhere to the study visit schedule and comply with all other protocol requirements
3.Capable of and willing to provide written informed consent

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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1.Currently participating in any follow-up period of another RG 101 clinical study.
Note: Participation in other investigational studies after the conclusion of the parent RG 101 study and/or concurrently with this observational study is allowed.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess long-term safety in subjects who previously received at least one dose of RG 101;Secondary Objective: In subjects who previously participated in a parent study as a chronic hepatitis C (CHC) subject:<br>•To assess HCV viral load<br>•To assess viral resistance<br>;Primary end point(s): Incidence of adverse events (AEs)<br>;Timepoint(s) of evaluation of this end point: Over a period of 24 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): All Subjects: <br>•Clinical laboratory measures, vital signs, electrocardiograms, and physical examinations<br>Subjects who Participated in a Parent Study as a CHC Subject<br>•Proportion of subjects with sustained virologic response (SVR) across visits (Timepoint of SVR will be calculated from the end of treatment in the parent study of RG-101)<br>•Proportion of subjects who relapse across visits<br>•Change in HCV viral load across visits<br>•Proportion of subjects with viral resistance among subjects who experienced relapse<br>•Duration of response and time to relapse<br>•Change in fibroscan and biomarkers (including microRNAs)<br>•Liver ultrasound and alpha-fetoprotein (AFP) screening for hepatic abnormalities<br>;Timepoint(s) of evaluation of this end point: At 6 month intervals over a period of 24 months