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NCT00235391 · ClinicalTrials.gov registry record · Phase 3
Expanded Access of Deferasirox to Patients With Congenital Disorders of Red Blood Cells and Chronic Iron Overload
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,683
- Enrollment target
NCT00235391: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00235391 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,683 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (118% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00235391, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,683 participants
- Enrollment target
Study Summary
This is an open-label, non-randomized, multi-center trial designed to provide expanded access of deferasirox to patients with congenital disorders of red blood cells and chronic iron overload from blood transfusions who cannot adequately be treated with locally approved iron chelators.
Primary Outcome
Safety as assessed by the number of participants with death, serious adverse events (SAE), and/or Adverse Events (AEs) leading to study drug interruption or discontinuation. Note: only treatment emergent AEs are summarized.
Interventions
- DRUG Deferasirox
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,683 participants |
| Start Date | 2005-10 |
| Est. Completion | 2008-10 |
| Phase | Phase 3 |
What the finished NCT00235391 record still lists
NCT00235391 is an interventional study that assigns participants to a tested intervention. Its 1,683 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (118% higher).
The record links to 0 conditions, and to 1 intervention - of which Deferasirox is the first listed.
NCT00235391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00235391 about?
NCT00235391 is a clinical study titled "Expanded Access of Deferasirox to Patients With Congenital Disorders of Red Blood Cells and Chronic Iron Overload". This is an open-label, non-randomized, multi-center trial designed to provide expanded access of deferasirox to patients with congenital disorders of red blood cells and chronic iron overload from blood transfusions who cannot adequately be treated with locally approved iron chelators.
What is the current status of trial NCT00235391?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,683 participants. The study started on 2005-10. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00235391?
The interventions under investigation include: Deferasirox (DRUG).
Who is sponsoring clinical trial NCT00235391?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00235391's enrollment target sits among peer trials
1,683 134th of 2000 higher than 1,866 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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