Observational study with no interventions: This is an observational study and there will be no clinical interventions.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
Patients are eligible for inclusion in the study only if they meet all of the following criteria:
1. Patient has received at least 1 dose of an RPx product and has completed or discontinued participation in the parent study.
2. 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.
Exclusion Criteria:
Patients are excluded from the study if the following criterion applies:
1\. Cannot comply with the requirements of the study.
Primary outcome measure(s)
Evaluate the long-term safety of patients treated with an RPx product — Every 3 months (Q3M) (± 30 days) for 5 years from enrollment on this study to assess potential delayed risks
Identify any delayed adverse event(s) related to treatment with an RPx product — Every 3 months (Q3M) (± 30 days) for 5 years from enrollment on this study to assess potential delayed risks
Identify systemic HSV-1 infection related to treatment with an RPx product — Every 3 months (Q3M) (± 30 days) for 5 years from enrollment on this study to assess potential delayed risks
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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