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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 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 17 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00084084
The ClinicalTrials.gov registry entry for NCT00084084 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Agalsidase alfa is the first listed.
NCT00084084 reports 0 study locations.
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.
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