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An Observational Study of Carbaglu® for the Treatment of MMA and PA in Adults and Pediatrics

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Site contacts updated at 5 of 5 sitesv6
  2. Study sites: 3 to 5v5
  3. Study sites: 2 to 3v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    v3
  5. Enrollment target: 10 to 20v2 Show 8 more changesShow less
    • Start date: Mar 2022 to Jun 30, 2022
    • Primary endpoints: 1 to 2
    • Primary completion date: Mar 2032 to Jun 30, 2032
    • Study completion date: Mar 2033 to Jun 30, 2032
    • Secondary endpoint revised
    • Study description expanded, about 23 words
    • Study title expanded, about 6 words
    • Collaborators expanded, about 3 words
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To obtain short-term and long-term clinical safety information, in pediatric and adult patients with PA and MMA treated with Carbaglu®.
Trial Details
NCT Number NCT05040178
Lead Sponsor RECORDATI GROUP
Collaborators: Target PharmaSolutions, Inc.
Conditions
(from sponsor)		 Hyperammonemia, Methylmalonic Acidemia, Propionic Acidemia
Related terms Hyperammonemia, Methylmalonic acidemia, Propionic Acidemia
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov