deltatrials
Completed PHASE3 INTERVENTIONAL 1-arm NCT01347073

Study of the Safety, Pharmacokinetics and Efficacy of HPN-100, in Pediatric Subjects With Urea Cycle Disorders (UCDs)

A Switch-Over, Open-Label Study of the Safety, Pharmacokinetics, and Efficacy of HPN-100, Followed by Long-Term Treatment With HPN-100, in Pediatric Subjects Under 6 Years of Age With Urea Cycle Disorders (UCDs)

Sponsor: Amgen

Conditions Urea Cycle Disorders
Interventions HPN-100
Updated 9 times since 2017 Last updated: Jun 18, 2024 Started: Jul 31, 2011 Primary completion: Feb 28, 2013 Completion: Mar 31, 2013
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Urea Cycle Disorders, this trial is completed. The trial is conducted by Amgen and has accumulated 9 data snapshots since 2011. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotCompleted~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotCompleted~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshotCompleted~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 12 months · monthly snapshotCompleted

Change History

9 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Aug 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jul 2024 — Aug 2024 [monthly]

    Completed PHASE3

  5. Dec 2021 — Jul 2024 [monthly]

    Completed PHASE3

▶ Show 4 earlier versions

  1. Jan 2021 — Dec 2021 [monthly]

    Completed PHASE3

  2. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

  3. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE3

  4. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE3

    First recorded

Jul 2011

Trial started

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

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