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A Cohort Study on the Safety and Efficacy of XH-02 in Treating Hypoparathyroidism

StatusSuspended
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment suspended Sponsor's reason: Enrollment temporarily suspended in accordance with a newly implemented regulation, State Council Decree No. 818, on clinical research and clinical translation of new biomedical technologies; pending review and approval. Eligibility criteria shortened, about 8 words · Site details revised · Publications: details revised at 11 of 11 entries Show 3 more changesShow less
    • Eligibility criteria shortened, about 8 words
    • Site details revised
    • Publications: details revised at 11 of 11 entries
  2. Study title revisedv2 See this version in full on ClinicalTrials.gov ↗
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
XH-02 is an mRNA nucleic acid drug that expresses PTH in the body following intravenous or subcutaneous injection, providing PTH replacement therapy for patients with hypoparathyroidism. Previous clinical studies have demonstrated the safety of subcutaneously administered XH-02 in several patients with hypoparathyroidism and have yielded clear efficacy results. This study aims to further validate the safety and efficacy of subcutaneously injected XH-02 in the treatment of hypoparathyroidism in a expanded cohort.
Trial Details
NCT Number NCT07540286
Lead Sponsor Peking Union Medical College Hospital
Conditions Hypoparathyroidism
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov