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NotablePrimary and study completion dates: Sep 2025 to Oct 2028Primary endpoints: 2 to 1 · Trial status: Enrolling by Invitation to Active, Not Recruiting · Enrollment target: estimated 12 to confirmed 27 · 4 morev7Show 7 more changesShow less
Primary endpoints: 2 to 1
Trial status: Enrolling by Invitation to Active, Not Recruiting
MinorStart date changed from estimate of Mar 2021 to Mar 14, 2021v5
MinorStart date: Jan 2021 to Mar 2021v4
MinorRe-verified, no change to tracked fieldsv3
NotableTrial status: Not Yet Recruiting to Enrolling by InvitationStart date: Nov 2020 to Jan 2021 · Study sites: 0 to 1 · Secondary endpoints: 7 to 4v2Show 3 more changesShow less
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.