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Long Term Follow-Up for RGX-111

StatusEnrolling by Invitation
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Enrollment target: 7 to 21 Secondary endpoints: 1 to 9 · Study description shortened, about 2 wordsv3 Show 2 more changesShow less
    • Secondary endpoints: 1 to 9
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Minor Enrollment target: 8 to 7 Study sites: 3 to 2 · Secondary endpoints: 9 to 1 · Study description shortened, about 2 wordsv2 Show 3 more changesShow less
    • Study sites: 3 to 2
    • Secondary endpoints: 9 to 1
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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-111-5101 is a long-term follow up study that evaluates the long-term safety and efficacy of RGX-111 in participants who have received RGX-111 (a gene therapy intended to deliver a functional copy of the alpha-L-iduronidase gene (IDUA) to the central nervous system) in a separate parent study.
Trial Details
NCT Number NCT06103487
Lead Sponsor REGENXBIO Inc.
Conditions Mucopolysaccharidosis I
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov