A Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate in Pediatric Subjects Under 2 Years of Age With Urea Cycle Disorders
An Open Label Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate (GPB; RAVICTI®) in Pediatric Subjects Under Two Years of Age With Urea Cycle Disorders (UCDs)
Sponsor: Amgen
A PHASE4 clinical study on Urea Cycle Disorder, this trial is completed. The trial is conducted by Amgen and has accumulated 10 data snapshots since 2014. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Status Flow
Change History
10 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE4
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE4
-
Aug 2024 — Sep 2024 [monthly]
Completed PHASE4
-
Jul 2024 — Aug 2024 [monthly]
Completed PHASE4
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE4
▶ Show 5 earlier versions
-
Apr 2019 — Jan 2021 [monthly]
Completed PHASE4
-
Jun 2018 — Apr 2019 [monthly]
Completed PHASE4
-
Sep 2017 — Jun 2018 [monthly]
Completed PHASE4
Status: Active Not Recruiting → Completed
-
Feb 2017 — Sep 2017 [monthly]
Active Not Recruiting PHASE4
Status: Recruiting → Active Not Recruiting
-
Jan 2017 — Feb 2017 [monthly]
Recruiting PHASE4
First recorded
Dec 2014
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Amgen
For direct contact, visit the study record on ClinicalTrials.gov .