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A Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin

Study acronym: SkyPASS
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Study sites: 23 to 27v8
  2. Re-verified, no change to tracked fieldsv7
  3. Study sites: 1 to 23v6
  4. 2 versions Re-verified since Jan 9, 2024, no change to tracked fieldsv4-v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 2023 to Mar 20, 2023
    v3
  6. Primary endpoints revised (2)
    • Secondary endpoints: 5 to 6
    • Study title shortened, about 4 words
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this study is to further characterise the potential long-term safety risks of lonapegsomatropin in patients treated with lonapegsomatropin under real-world conditions in the post-marketing setting.
Trial Details
NCT Number NCT05775523
Lead Sponsor Ascendis Pharma Endocrinology Division A/S
Conditions
(from sponsor)		 Growth Hormone Deficiency
Related terms Dwarfism, Pituitary, Failure to Thrive
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov