Efficacy and Safety of HPN-100 for the Treatment of Adults With Urea Cycle Disorders
A Phase 3, Randomized, Double-Blind, Cross-Over, Active-Controlled Study of the Efficacy and Safety of HPN-100, Glyceryl Tri-(4-phenylbutyrate), for the Treatment of Adults With Urea Cycle Disorders (Help UCD)
Sponsor: Amgen
Listed as NCT00992459, this PHASE3 trial focuses on Urea Cycle Disorders and remains completed. Sponsored by Amgen, it has been updated 8 times since 2009, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
8 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
-
Aug 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jul 2024 — Aug 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE3
▶ Show 3 earlier versions
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
-
Feb 2017 — Jun 2018 [monthly]
Completed PHASE3
-
Jan 2017 — Feb 2017 [monthly]
Completed PHASE3
First recorded
Oct 2009
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 .