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Natural History and Advanced Genetic Study of Pyruvate Dehydrogenase Complex Deficiencies

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 years 11 months later Sep 2026 → Sep 2030
See other at-risk trials from University of Pittsburgh

Record History

  1. Primary completion pushed from Sep 2026 to Sep 2030 Completion pushed from Sep 2026 to Dec 2030 · Secondary endpoints: details revised at 1 of 1 entry · Publications: details revised at 7 of 7 entries · 2 more Show 5 more changesShow less
    • Completion pushed from Sep 2026 to Dec 2030
    • Secondary endpoints: details revised at 1 of 1 entry
    • Publications: details revised at 7 of 7 entries
    • Eligibility criteria expanded, about 5 words
    • Study description expanded, about 2 words
  2. Re-verified, no change to tracked fieldsv13
  3. Primary and study completion dates: Aug 2025 to Sep 2026v12
  4. Site contact updatedv11
  5. Primary and study completion dates: Aug 2024 to Aug 2025 Site contact updatedv10 Show 1 more changeShow less
    • Site contact updated
Show 8 earlier versionsHide 8 earlier versions
  1. 3 versions Re-verified since Mar 21, 2022, no change to tracked fieldsv7-v9
  2. Lead sponsor: University Hospitals Cleveland Medical Center to University of Pittsburgh Enrollment target: 75 to 150 · Study site revisedv6 Show 2 more changesShow less
    • Enrollment target: 75 to 150
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  3. Enrollment target: 150 to 75 Primary and study completion dates: Aug 2019 to Aug 2024 · Study description shortened, about 113 words · Site contact updated · 1 morev5 Show 4 more changesShow less
    • Primary and study completion dates: Aug 2019 to Aug 2024
    • Study description shortened, about 113 words
    • Site contact updated
    • Publications: 2 to 7

    See this version in full on ClinicalTrials.gov ↗

  4. 2 versions Re-verified since Apr 30, 2018, no change to tracked fieldsv3-v4
  5. Secondary endpoints: details revised at 1 of 1 entryv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Children and adults with pyruvate dehydrogenase complex deficiency (PDCD) are participating in a research study seeking to better understand the genetic causes, symptoms, usefulness of current treatments, and outcomes for these disorders. The research project involves completing a questionnaire about the individual or family's medical history and experiences with PDCD, review of medical records by the researchers, and in some cases, advanced genetic testing.
Trial Details
NCT Number NCT03056794
Lead Sponsor University of Pittsburgh
Collaborators: Rare Diseases Clinical Research Network, National Institute of Neurological Disorders and Stroke (NINDS)
Conditions Pyruvate Dehydrogenase Complex Deficiency Disease
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov