deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT01599286

Short-Term Outcome of N-Carbamylglutamate in the Treatment of Acute Hyperammonemia (STO)

Sponsor: Boston Children's Hospital

Conditions Carbamoyl-Phosphate Synthase I Deficiency Disease Methylmalonic Acidemia Ornithine Carbamoyltransferase Deficiency Propionic Acidemia, Type I and/or Type II
Interventions Carbaglu Placebo
Updated 17 times since 2017 Last updated: Jan 25, 2021 Started: Sep 1, 2012 Primary completion: Apr 30, 2019 Completion: Apr 30, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Carbamoyl-Phosphate Synthase I Deficiency Disease and Methylmalonic Acidemia, this trial is completed. The trial is conducted by Boston Children's Hospital and has accumulated 17 data snapshots since 2012. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~May 2017 · 3 months · monthly snapshot~May 2017 – ~Oct 2017 · 5 months · monthly snapshot~Oct 2017 – ~Jun 2018 · 8 months · monthly snapshot~Jun 2018 – ~Apr 2019 · 10 months · monthly snapshot~Apr 2019 – ~Jun 2019 · 2 months · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Mar 2020 · 8 months · monthly snapshot~Mar 2020 – ~Sep 2020 · 6 months · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Dec 2022 · 21 months · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

17 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE2

  5. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE2

▶ Show 12 earlier versions

  1. Mar 2021 — Dec 2022 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  2. Jan 2021 — Mar 2021 [monthly]

    Active Not Recruiting PHASE2

  3. Sep 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2

  4. Mar 2020 — Sep 2020 [monthly]

    Active Not Recruiting PHASE2

  5. Jul 2019 — Mar 2020 [monthly]

    Active Not Recruiting PHASE2

  6. Jun 2019 — Jul 2019 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  7. Apr 2019 — Jun 2019 [monthly]

    Recruiting PHASE2

  8. Jun 2018 — Apr 2019 [monthly]

    Recruiting PHASE2

  9. Oct 2017 — Jun 2018 [monthly]

    Recruiting PHASE2

  10. May 2017 — Oct 2017 [monthly]

    Recruiting PHASE2

  11. Feb 2017 — May 2017 [monthly]

    Recruiting PHASE2

  12. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2

    First recorded

Sep 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Boston Children's Hospital
  • Children's Hospital Colorado
  • Children's Hospital of Philadelphia
  • Children's National Research Institute
  • Icahn School of Medicine at Mount Sinai
  • Mendel Tuchman
  • Stanford University
  • University Hospitals Cleveland Medical Center
  • University of California, Los Angeles
  • University of Pittsburgh
Data source: Children's National Research Institute

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations