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

• Register: EUCTR
• Last refreshed on: 2 October 2017
• Main ID: EUCTR2016-002069-77-HU
• Date of registration: 18/10/2016
• Prospective Registration: No
• Primary sponsor: Regulus Therapeutics Inc.
• Public title: Follow-Up clinical trial in patients who have previously received test product RG-101 for assessment of long term safety and efficacy
• Scientific title: An Observational Long-Term Safety and Efficacy Follow-Up Study of Subjects Who Have Previously Received RG-101
• Date of first enrolment: 06/10/2016
• Target sample size: 200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002069-77
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Follow up trial without the administration of study drug If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Follow up trial without the administration of study drug Number of treatment arms in the trial: 0
• Phase: Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Greece, Hungary, Netherlands, Serbia

Contacts

• Name: Clinical Trials Info
• Affiliation: Accelsiors CRO and Consultancy Services Ltd

• Name: Clinical Trials Info
• Affiliation: Accelsiors CRO and Consultancy Services Ltd

Key inclusion & exclusion criteria

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Hepatitis C Patients
MedDRA version: 19.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations
MedDRA version: 19.0 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
MedDRA version: 19.0 Level: LLT Classification code 10019761 Term: Hepatitis cytomegalovirus System Organ Class: 10021881 - Infections and infestations
MedDRA version: 19.0 Level: LLT Classification code 10057394 Term: Hepatitis C positive System Organ Class: 100000004848
MedDRA version: 19.0 Level: LLT Classification code 10019760 Term: Hepatitis CMV System Organ Class: 10021881 - Infections and infestations
MedDRA version: 19.0 Level: LLT Classification code 10047457 Term: Viral hepatitis C System Organ Class: 10021881 - Infections and infestations

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Intervention(s)

Product Code: RG-101
Pharmaceutical Form: Solution for injection
Current Sponsor code: RG2459
Other descriptive name: RG2459
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-

Primary Outcome(s)

Main Objective: To assess long-term safety in subjects who previously received at least one dose of RG 101

Primary end point(s): Incidence of adverse events (AEs)

Secondary Objective: In subjects who previously participated in a parent study as a chronic hepatitis C (CHC) subject:
•To assess HCV viral load
•To assess viral resistance

Timepoint(s) of evaluation of this end point: Over a period of 24 months

Secondary Outcome(s)

Secondary end point(s): All Subjects:
•Clinical laboratory measures, vital signs, electrocardiograms, and physical examinations
Subjects who Participated in a Parent Study as a CHC Subject
•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)
•Proportion of subjects who relapse across visits
•Change in HCV viral load across visits
•Proportion of subjects with viral resistance among subjects who experienced relapse
•Duration of response and time to relapse
•Change in fibroscan and biomarkers (including microRNAs)
•Liver ultrasound and alpha-fetoprotein (AFP) screening for hepatic abnormalities

Timepoint(s) of evaluation of this end point: At 6 month intervals over a period of 24 months

Secondary ID(s)

2016-002069-77-GR

RG101-05

Source(s) of Monetary Support

Regulus Therapeutics Inc.