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NCT01363908 · ClinicalTrials.gov registry record · Phase 2
Safety, Efficacy and Pharmacokinetics of an Oral Iron Chelator Given for a Year to Pediatric Patients With Iron Overload
A Phase 2 study, sponsored by Shire.
- Terminated
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT01363908 is a Phase 2 study that was terminated before completion, run by Shire. The registered enrollment target is 30 participants.
The verdict
NCT01363908, a Phase 2 study, was terminated before completion, sponsored by Shire.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is an open-label study to assess the pharmacokinetics, safety, efficacy and tolerability of SSP-004184AQ. The study consists of two phases: the pharmacokinetic phase, using a single 16 mg/kg dose of SSP-004184AQ; and the chronic dosing phase, during which patients will receive an additional 48 weeks of SSP-004184AQ dosing. Two age groups will be studied: 6-\<12, and 12-\<18 years old. The study is designed to initially assess the pharmacokinetics and safety of SSP-004184AQ in older children (adolescents, 12-\<18 years old) and then if deemed safe, in younger children (6-\<12 years old).
Interventions
- DRUG SPD602
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-08-10 |
| Est. Completion | 2014-05-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01363908
The ClinicalTrials.gov registry entry for NCT01363908 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 30 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 SPD602 is the first listed.
NCT01363908 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01363908 about?
NCT01363908 is a clinical study titled "Safety, Efficacy and Pharmacokinetics of an Oral Iron Chelator Given for a Year to Pediatric Patients With Iron Overload". This is an open-label study to assess the pharmacokinetics, safety, efficacy and tolerability of SSP-004184AQ. The study consists of two phases: the pharmacokinetic phase, using a single 16 mg/kg dose of SSP-004184AQ; and the chronic dosing phase, during which patients will receive an additional 48 ...
What is the current status of trial NCT01363908?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2011-08-10. Estimated completion is 2014-05-13.
What interventions are being tested in trial NCT01363908?
The interventions under investigation include: SPD602 (DRUG).
Who is sponsoring clinical trial NCT01363908?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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