Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00069641 · ClinicalTrials.gov registry record · Phase 2
Iduronate-2-sulfatase Enzyme Replacement Therapy in Mucopolysaccharidosis II (MPS II)
A Phase 2 study, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 96
- Enrollment target
NCT00069641: Completed Phase 2 study, sponsored by Shire.
NCT00069641 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 96 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00069641, a Phase 2 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 96 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether the administration of iduronate-2-sulfatase enzyme in a weekly or every other week therapy frequency is safe and efficacious in patients with MPS II.
Primary Outcome
The 2-component composite variable consists of the sum of the ranked changes from baseline to Week 53 for percent predicted Forced Vital Capacity (FVC) and 6-Minute Walking Test (6MWT) total distance walked. For the 2 treatment groups being compared, ranking occurred within the comparison treatment groups combined (idursulfase weekly and placebo treatment groups). These comparison groups were pooled and ranked for each component separately. Within each component (% predicted FVC, 6MWT), the chan
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Iduronate-2-sulfatase enzyme replacement therapy
- BIOLOGICAL iduronate-2-sulfatase enzyme replacement therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2003-09-18 |
| Est. Completion | 2005-03-16 |
| Phase | Phase 2 |
What the finished NCT00069641 record still lists
NCT00069641 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00069641 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00069641 about?
NCT00069641 is a clinical study titled "Iduronate-2-sulfatase Enzyme Replacement Therapy in Mucopolysaccharidosis II (MPS II)". The purpose of this study is to determine whether the administration of iduronate-2-sulfatase enzyme in a weekly or every other week therapy frequency is safe and efficacious in patients with MPS II.
What is the current status of trial NCT00069641?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2003-09-18. Estimated completion is 2005-03-16.
What interventions are being tested in trial NCT00069641?
The interventions under investigation include: Placebo (BIOLOGICAL), Iduronate-2-sulfatase enzyme replacement therapy (BIOLOGICAL), iduronate-2-sulfatase enzyme replacement therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT00069641?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00069641's enrollment target sits among peer trials
96 747th of 2000 higher than 1,242 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03401762 · 96 participants · NA
Wearable MCI to Reduce Muscle Co-activation in Acute and Chronic Stroke
- NCT03471260 · 96 participants · Phase 1
Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies
- NCT03549559 · 96 participants · NA
Imaging Histone Deacetylase in the Heart
- NCT03841058 · 96 participants · Phase 2
Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI