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

An Observational Long-Term Safety and Efficacy Follow-Up Study of Subjects Who Have Previously Received RG-101

Status

Active, not recruiting

Phases

Phase 1Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002069-77-GR

Enrollment

200

Registered

2016-10-14

Start date

2016-12-01

Completion date

Unknown

Last updated

2017-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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 Classific

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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: •To assess HCV viral load •To assess viral resistance ;Primary end point(s): Incidence of adverse events (AEs) ;Timepoint(s) of evaluation of this end point: Over a period of 24 months	—

Measure

Time frame

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: •To assess HCV viral load •To assess viral resistance ;Primary end point(s): Incidence of adverse events (AEs) ;Timepoint(s) of evaluation of this end point: Over a period of 24 months

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Greece, Hungary, Netherlands, Serbia, United States

Contacts

Public ContactClinical Trials Info

Accelsiors CRO and Consultancy Services Ltd

clinicaltrials@accelsiors.com+36 1 299 00 91

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026