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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: Clinical Trial Phase 2 study, sponsored by Shire.
NCT01363908 is a Phase 2 study that was terminated before completion, run by Shire. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The pharmacokinetic (PK) parameters of SPD602 were measured in plasma of all patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. PK blood samples were collected as follows: Pre-dose on Day 1 (within 60 minutes prior to investigational product administration) and at 0.5, 1, 2, 3, 4, 8 hours (±3 minutes) and 24 hours (±30 minutes) post-dose. Plasma concentrations of SPD602 were determined using a validated liquid chromatog
Interventions
- DRUG SPD602
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-08-10 |
| Est. Completion | 2014-05-13 |
| Phase | Phase 2 |
Why NCT01363908 stopped before completion
NCT01363908 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which SPD602 is the first listed.
NCT01363908 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01363908's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 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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