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An Extension Study of JR-141 to Evaluate the Long-term Safety and Efficacy in MPS II (Hunter Syndrome) Subjects

StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv10
  2. Study sites: 9 to 10v9
  3. Eligibility criteria shortened, about 234 words
    • Study title shortened, about 1 word
    v8
  4. Study sites: 6 to 9v7
  5. Study sites: 1 to 6v6
Show 4 earlier versionsHide 4 earlier versions
  1. Eligibility criteria expanded, about 45 wordsv5
  2. Eligibility criteria shortened, about 147 wordsv4
  3. Primary endpoints revised (4)
    • Eligibility criteria expanded, about 58 words
    • Secondary endpoints revised (2)
    • Study title shortened, about 1 word
    v3
  4. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Feb 1, 2023 to Feb 22, 2023
    • Site contact updated
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
An extension of Global Phase III open-label, multicenter designed to evaluate the Long-term safety and efficacy of study drug for the treatment of the MPS II.
Trial Details
NCT Number NCT05594992
Lead Sponsor JCR Pharmaceuticals Co., Ltd.
Conditions
(from sponsor)		 Mucopolysaccharidosis II
Related terms Mucopolysaccharidosis II
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov