A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorReplimune, Inc.
About this trial
This is a noninterventional, observational, long-term follow-up (LTFU) study. Patients in this study will be followed for 5 years from enrollment on this study to assess potential delayed risks of RPx products. Eligible participants for this LTFU study include patients who received at least 1 dose of an RPx product under the interventional parent study. Patients will be rolled over into this LTFU study after completion of the Replimune-sponsored parent study (ie, either completion of the LTFU in the parent study or withdrawal from the parent study). All patients in ongoing RPx studies will be asked to participate in this LTFU study so that the Sponsor can evaluate potential delayed risks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient has received at least 1 dose of an RPx product and has completed or discontinued participation in the parent study.
Patient or patient's legal guardian has provided signed informed consent (or assent) as , which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Disqualifiers
None
Trial population
Patients are eligible for inclusion in the study only if they meet all of the inclusion criteria. Deviations from the entry criteria that would be considered a protocol waiver or exemption are not permitted.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observational study with no interventions
Other interventionThis is an observational study and there will be no clinical interventions.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Patients who received at least 1 dose of an RPx [RP1, RP2, RP3]1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the long-term safety of patients treated with an RPx product
Time frame
Every 3 months (Q3M) (± 30 days) for 5 years from enrollment on this study to assess potential delayed risks2
Identify any delayed adverse event(s) related to treatment with an RPx product
Time frame
Every 3 months (Q3M) (± 30 days) for 5 years from enrollment on this study to assess potential delayed risks3
Identify systemic HSV-1 infection related to treatment with an RPx product
Time frame
Every 3 months (Q3M) (± 30 days) for 5 years from enrollment on this study to assess potential delayed risksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov