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Long-term Follow-Up for RGX-121
Long-term Follow-Up for RGX-121

NCT04597385

Active Not RecruitingN/A

Sponsor: REGENXBIO Inc.

Conditions: Mucopolysaccharidosis II

Interventions: Long-term Follow-Up

Countries: United States, Brazil

RGX-121-5101 is an observational long-term follow-up study to the RGX-121-101 or RGX-121-1102 studies where participants received RGX-121, a gene therapy intended to deliver a functional copy of the iduronate-2-sulfatase gene (IDS) to the central nervous system. This study will evaluate the long-term safety and efficacy of RGX-121.

Eligibility overview

Sex: MALE

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

* To be eligible, a participant must have previously received RGX-121 in a separate parent trial.
* Participant or participant's legal guardian(s) is/(are) willing and able to provide written, signed informed consent

Exclusion Criteria:

* Participant has not received RGX-121 previously in a separate parent trial.
Locations (4)
  • San Francisco, California, United States
  • New Brunswich, New Jersey, United States
  • Philadelphia, Pennsylvania, United States
  • Porto Alegre, Brazil