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Longitudinal Study of the Porphyrias

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Sponsor changed: Icahn School of Medicine at Mount Sinai to The American Porphyrias Expert Collaborative
    • Study sites: 15 to 16
    v23
  2. Primary and study completion dates: Jun 30, 2025 to Jun 30, 2030
    • Publications: details revised at 3 of 4 entries
    v22
  3. Primary and study completion dates: Jun 2025 to Jun 30, 2025
    • Site contacts updated at 2 of 15 sites
    • Collaborators expanded, about 10 words
    • Publications: 1 to 4
    v21
  4. Primary completion date: Sep 2024 to Jun 2025
    • Study completion date: Dec 2024 to Jun 2025
    • Site contacts updated at 1 of 15 sites
    v20
  5. Site contacts updated at 1 of 15 sitesv19
Show 17 earlier versionsHide 17 earlier versions
  1. Site details revised at 7 of 15 sitesv18
  2. Start date: Nov 2010 to Nov 1, 2010
    • Site details revised at 3 of 15 sites
    v17
  3. Enrollment target: 800 to 1500v16 Show 4 more changesShow less
    • Study sites: 10 to 15
    • Study description revised
    • Study arms: 9 to 10
    • Eligibility criteria shortened, about 2 words
  4. Primary completion date: Sep 2019 to Sep 2024
    • Study completion date: Dec 2019 to Dec 2024
    v15
  5. Site contacts updated at 2 of 10 sitesv14
  6. Site contacts updated at 3 of 10 sitesv13
  7. Site contacts updated at 3 of 10 sitesv12
  8. Re-verified, no change to tracked fieldsv11
  9. Site details revised at 2 of 10 sitesv10
  10. Re-verified, no change to tracked fieldsv9
  11. Study sites: 8 to 10v8
  12. Enrollment target: 600 to 800
    • Study sites: 6 to 8
    v7
  13. 2 versions Re-verified since May 5, 2015, no change to tracked fieldsv5-v6
  14. Primary completion date: Dec 2014 to Sep 2019v4 Show 4 more changesShow less
    • Primary endpoints: 10 to 2
    • Study completion date: Dec 2014 to Dec 2019
    • Secondary endpoints: 10 to 2
    • Site contacts updated at 2 of 6 sites
  15. Re-verified, no change to tracked fieldsv3
  16. Study sites revised (6)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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The objective of this protocol is to conduct a longitudinal multidisciplinary investigation of the human porphyrias including the natural history, morbidity, pregnancy outcomes, and mortality in people with these disorders.
Trial Details
NCT Number NCT01561157
Lead Sponsor The American Porphyrias Expert Collaborative
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)		 Acute Porphyrias, Cutaneous Porphyrias
Related terms Coproporphyria, Porphyria, Acute Intermittent, Porphyrias, Protoporphyria, Erythropoietic
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov