deltatrials
Completed PHASE4 INTERVENTIONAL 1-arm NCT00607386

Safety and Clinical Outcomes in Hunter Syndrome Patients 5 Years of Age and Younger Receiving Idursulfase Therapy

A Multi-Center, Open-Label Study Evaluating Safety and Clinical Outcomes in Hunter Syndrome Patients 5 Years of Age and Younger Receiving Idursulfase Enzyme Replacement Therapy

Sponsor: Covance

Interventions Idursulfase
Updated 7 times since 2017 Last updated: May 14, 2021 Started: Dec 31, 2007 Primary completion: Jul 8, 2011 Completion: Jul 8, 2011
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE4 trial investigates Hunter Syndrome and MPS II and is currently completed. Covance leads this study, which shows 7 recorded versions since 2007 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

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 – ~Sep 2021 · 8 months · monthly snapshotCompleted~Sep 2021 – ~Jul 2024 · 34 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 21 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE4

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  3. Sep 2021 — Jul 2024 [monthly]

    Completed PHASE4

  4. Jan 2021 — Sep 2021 [monthly]

    Completed PHASE4

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE4

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE4

  2. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE4

    First recorded

Dec 2007

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Covance
  • PRA Health Sciences
  • PharmaNet
  • Shire
Data source: Takeda

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