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Efficacy and Safety of Subcutaneous Injection of XH-02 in the Treatment of Adult Hypoparathyroidism

StatusSuspended
PhasePhase 1/2
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. Primary completion pushed from May 31, 2026 to May 30, 2027 · Completion pushed from Jun 30, 2026 to Aug 30, 2027 · Eligibility criteria expanded, about 29 words Show 3 more changesShow less
    • Primary completion pushed from May 31, 2026 to May 30, 2027
    • Completion pushed from Jun 30, 2026 to Aug 30, 2027
    • Eligibility criteria expanded, about 29 words
  2. Trial status: Recruiting to Suspended Sponsor's reason: Enrollment temporarily suspended in accordance with a newly implemented regulation, State Council Decree No. 818, on clinical research and… Primary completion date: May 31, 2026 to May 30, 2027 · Completion date: Jun 30, 2026 to Aug 30, 2027 · Eligibility criteria expanded, about 7 words · 2 more Show 5 more changesShow less
    • Primary completion date: May 31, 2026 to May 30, 2027
    • Completion date: Jun 30, 2026 to Aug 30, 2027
    • Eligibility criteria expanded, about 7 words
    • Site details revised
    • Publications: details revised at 11 of 11 entries
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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. Animal studies have shown pharmacodynamic effects of XH-02, with a favorable safety profile. A clinical study of intravenously administered XH-02 has been completed in patients with hypoparathyroidism, yielding clear pharmacodynamic results and demonstrating good safety. This study aims to evaluate the safety and efficacy of subcutaneously injected XH-02 in patients with hypoparathyroidism.
Trial Details
NCT Number NCT07530705
Lead Sponsor Peking Union Medical College Hospital
Conditions Hypoparathyroidism
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov