Status:
ENROLLING_BY_INVITATION
Long Term Follow-Up for RGX-111
Lead Sponsor:
REGENXBIO Inc.
Conditions:
Mucopolysaccharidosis I
Eligibility:
All Genders
Brief Summary
RGX-111-5101 is a long-term follow up study that evaluates the long term safety of RGX-111 in participants who have received RGX-111 (a gene therapy intended to deliver a functional copy of the alpha-...
Detailed Description
This is a prospective, multicenter, observational, follow-up study to evaluate the long-term safety of RGX-111 after a single administration. Eligible participants are those who previously participate...
Eligibility Criteria
Inclusion
- To be eligible, a participant must have previously received RGX-111 in a separate parent trial.
- Participant or participant's legal guardian(s) is/(are) willing and able to provide written, signed informed consent.
Exclusion
- None.
Key Trial Info
Start Date :
July 24 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT06103487
Start Date
July 24 2023
End Date
September 1 2027
Last Update
July 3 2024
Active Locations (2)
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1
Children's Hospital of Orange County
Orange, California, United States, 92868
2
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903