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PROPEL - A Prospective Observational Patient Registry to Evaluate ENPP1 and ABCC6 Deficiency

StatusTerminated
PhaseNot specified
Started
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Record History

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  1. Trial terminated Sponsor's reason: The study was terminated by the sponsor prior to planned completion based on a review of the data across indications and overall program considerations. Study termination was not related to participant safety. Show 4 more changesShow less
    • Primary endpoints: details revised at 1 of 4 entries
    • Eligibility criteria expanded, about 8 words
    • Study description revised
    • Site details revised at 3 of 14 sites
  2. Final enrollment: 54 participants — 5% of the 1000 planned
    • Primary and study completion moved earlier from May 2034 to Aug 28, 2026
    • Enrollment closed, study ongoing
    • Site details revised at 14 of 14 sites
    v10
  3. Study sites: 13 to 14v9
  4. Site contacts updated at 1 of 13 sitesv8
  5. Study sites: 9 to 13v7
Show 5 earlier versionsHide 5 earlier versions
  1. Site contacts updated at 1 of 9 sitesv6
  2. Study sites: 1 to 9v5
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2024 to Jul 25, 2024
    • Site details revised
    v4
  4. Start date: May 2024 to Aug 2024
    • Study sites: 0 to 1
    v3
  5. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this prospective registry is to characterize the natural history of ectonucleotide pyrophosphatase/phosphodiesterase1(ENPP1) Deficiency and the infantile-onset form of adenosine triphosphate (ATP) binding cassette transporter protein subfamily C member 6 (ABCC6) Deficiency longitudinally. The registry will prospectively gather information about the genetic, biochemical, physiological, anatomic, radiographic, and functional manifestations (including patient reported outcomes \[PROs\]) of each disease during routine, standard-of-care visits, with the aim of developing a comprehensive understanding of the burden of illness and progressive nature of the disease.
Trial Details
NCT Number NCT06302439
Lead Sponsor Inozyme Pharma
Collaborators: GACI Global
Conditions
(from sponsor)		 Ectonucleotide Pyrophosphatase/Phosphodiesterase 1 Deficiency, ATP-Binding Cassette Subfamily C Member 6 Deficiency
Related terms Arterial calcification of infancy
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov