Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04176523 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Understanding the Long-Term Management of Organic Acidemia Patients With CARBAGLU®: A Mixed Methods Approach

Study acronym: PROTECT
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 5, 2024 (before its estimated December 30, 2024 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Jul 30, 2026 to Dec 30, 2024
    • Enrollment target: 75 to 95
    • Study sites: 23 to 32
    • Study completion date: Dec 30, 2026 to Jul 30, 2029
    v7
  2. Publications: details revised at 1 of 7 entriesv6
  3. Re-verified, no change to tracked fieldsv5
  4. Primary completion date: Jun 15, 2020 to Jul 30, 2026v4 Show 5 more changesShow less
    • Study sites: 21 to 23
    • Study completion date: Dec 15, 2021 to Dec 30, 2026
    • Secondary endpoints: details revised at 1 of 4 entries
    • Study description expanded, about 6 words
    • Publications: 1 to 7
  5. Site contacts updated at 15 of 21 sitesv3
  6. Study sites: 1 to 21v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a prospective mixed-design study focused on the long-term management of propionic aciduria (PA) and methylmalonic aciduria (MMA) with N-carbamylglutamate (NCG) maintenance therapy. Treatment characteristics, clinical outcomes, and healthcare utilization data of patients diagnosed PA or MMA treated \>6 months therapy with NCG are collected at baseline, 12 months, 18 months, 36 months and 54 months. Qualitative interviews with adult patients and caregivers are conducted \>6 months after study enrollment to gain a better understanding of the disease burden and the treatment burden of patients and their families.
Trial Details
NCT Number NCT04176523
Lead Sponsor RECORDATI GROUP
Conditions
(from sponsor)		 Methylmalonic Acidemia, Propionic Acidemia
Related terms Methylmalonic acidemia, Propionic Acidemia
Enrollment 95 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov