deltatrials
Completed PHASE4 INTERVENTIONAL 2-arm NCT03335488

Study of Glycerol Phenylbutyrate & Sodium Phenylbutyrate in Phenylbutyrate Naïve Patients With Urea Cycle Disorders (UCDs)

A Randomised, Controlled, Open-Label Parallel Arm Study of Safety, PK and Ammonia Control of RAVICTI® (Glycerol Phenylbutyrate) Oral Liquid and Sodium Phenylbutyrate in Phenylbutyrate Treatment Naïve Patients With Urea Cycle Disorders

Sponsor: Amgen

Conditions Urea Cycle Disorder
Interventions NaPBA RAVICTI
Updated 18 times since 2017 Last updated: Jun 18, 2024 Started: Feb 20, 2018 Primary completion: Jul 5, 2022 Completion: Dec 20, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE4 clinical study on Urea Cycle Disorder, this trial is completed. The trial is conducted by Amgen and has accumulated 18 data snapshots since 2018. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Dec 2017 – ~Jan 2018 · 31 days · monthly snapshot~Jan 2018 – ~Mar 2018 · 59 days · monthly snapshot~Mar 2018 – ~May 2018 · 2 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Nov 2018 · 5 months · monthly snapshot~Nov 2018 – ~Apr 2019 · 5 months · monthly snapshot~Apr 2019 – ~Nov 2019 · 7 months · monthly snapshot~Nov 2019 – ~Mar 2020 · 4 months · monthly snapshot~Mar 2020 – ~Jan 2021 · 10 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2022 · 13 months · monthly snapshot~Mar 2022 – ~May 2022 · 2 months · monthly snapshot~May 2022 – ~Apr 2023 · 11 months · monthly snapshot~Apr 2023 – ~Aug 2023 · 4 months · monthly snapshot~Aug 2023 – ~Jul 2024 · 11 months · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – present · 24 months · monthly snapshot

Change History

18 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE4

  2. Aug 2024 — Sep 2024 [monthly]

    Completed PHASE4

  3. Jul 2024 — Aug 2024 [monthly]

    Completed PHASE4

  4. Aug 2023 — Jul 2024 [monthly]

    Completed PHASE4

  5. Apr 2023 — Aug 2023 [monthly]

    Completed PHASE4

    Status: Recruiting → Completed

▶ Show 13 earlier versions

  1. May 2022 — Apr 2023 [monthly]

    Recruiting PHASE4

  2. Mar 2022 — May 2022 [monthly]

    Recruiting PHASE4

  3. Feb 2021 — Mar 2022 [monthly]

    Recruiting PHASE4

  4. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE4

  5. Mar 2020 — Jan 2021 [monthly]

    Recruiting PHASE4

  6. Nov 2019 — Mar 2020 [monthly]

    Recruiting PHASE4

  7. Apr 2019 — Nov 2019 [monthly]

    Recruiting PHASE4

  8. Nov 2018 — Apr 2019 [monthly]

    Recruiting PHASE4

  9. Jun 2018 — Nov 2018 [monthly]

    Recruiting PHASE4

  10. May 2018 — Jun 2018 [monthly]

    Recruiting PHASE4

  11. Mar 2018 — May 2018 [monthly]

    Recruiting PHASE4

  12. Jan 2018 — Mar 2018 [monthly]

    Recruiting PHASE4

    Status: Not Yet Recruiting → Recruiting

  13. Dec 2017 — Jan 2018 [monthly]

    Not Yet Recruiting PHASE4

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Amgen
Data source: Amgen

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

Study Locations

Barakaldo, Spain , Bern, Switzerland , Cleveland, United States , Dallas, United States , Gainesville, United States , Málaga, Spain , New York, United States , Padua, Italy , Pittsburgh, United States , Rome, Italy and 1 more location