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NCT00084084 · ClinicalTrials.gov registry record · Phase 2
Replagal Enzyme Replacement Therapy for Children With Fabry Disease
A Phase 2 study, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT00084084: Completed Phase 2 study, sponsored by Shire.
NCT00084084 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00084084, a Phase 2 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
Primary Objective(s): * To assess the safety of Replagal at a dose of 0.2 mg/kg administered over 40 (+/-10) minutes in children with Fabry disease * To assess the effect of Replagal on heart rate variability in patients 7 to 17 years of age Secondary Objective(s): * To determine the pharmacokinetics of Replagal at baseline and after the initiation of enzyme replacement therapy (ERT) * To determine exploratory measurements of efficacy including renal function (ie, estimated glomerular filtration rate \[eGFR\] and creatinine clearance), clinical outcomes (in Cohorts 1 and 2), and sweating and left ventricular mass index (LVMI) (Cohort 1, Phase 1 only)
Interventions
- DRUG Agalsidase alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2004-06-10 |
| Est. Completion | 2011-06-15 |
| Phase | Phase 2 |
What the finished NCT00084084 record still lists
NCT00084084 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Agalsidase alfa is the first listed.
NCT00084084 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00084084 about?
NCT00084084 is a clinical study titled "Replagal Enzyme Replacement Therapy for Children With Fabry Disease". Primary Objective(s): * To assess the safety of Replagal at a dose of 0.2 mg/kg administered over 40 (+/-10) minutes in children with Fabry disease * To assess the effect of Replagal on heart rate variability in patients 7 to 17 years of age Secondary Objective(s): * To determine the pharmacokine...
What is the current status of trial NCT00084084?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2004-06-10. Estimated completion is 2011-06-15.
What interventions are being tested in trial NCT00084084?
The interventions under investigation include: Agalsidase alfa (DRUG).
Who is sponsoring clinical trial NCT00084084?
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 NCT00084084's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 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
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