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NCT00873041 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Deferasirox in Non-transfusion Dependent Thalassemia Patients With Iron Overload and a One Year Open-label Extension Study
A Phase 2 study of Non-transfusion Dependent Thalassemia, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 166
- Enrollment target
- 20
- Study locations
NCT00873041: Completed Phase 2 study of Non-transfusion Dependent Thalassemia, sponsored by Novartis Pharmaceuticals.
NCT00873041 is a Phase 2 study of Non-transfusion Dependent Thalassemia that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 166 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00873041, a Phase 2 study of Non-transfusion Dependent Thalassemia, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 166 participants
- Enrollment target
- 20
- Study locations
Study Summary
CICL670A2209: This study will evaluate the safety and efficacy of deferasirox in non-transfusion dependent thalassemia patients with iron overload. Patients will be treated either with active treatment (deferasirox) or placebo for 12 months (core study phase). Patients who complete the core study phase will be offered to continue their study with the active treatment (deferasirox) in a 12 months extension phase. During the core and extension, the effects of treatment on iron overload in the liver will be evaluated using magnetic resonance imaging (MRI) assessments. CICL670A2209E1: A one-year open-label extension to a randomized, double-blind, placebo-controlled, phase II study to evaluate efficacy and safety of deferasirox in non-transfusion dependent thalassemia patients with iron overload (Thalassa).
Primary Outcome
LIC was measured by magnetic resonance imaging technique at baseline and Week 52. Estimates were obtained from an Analysis of Covariance (ANCOVA) model for change in LIC between baseline and Week 52 with treatment as factor and baseline LIC as covariate.
Conditions Studied
Interventions
- DRUG placebo
- DRUG deferasirox
Study Locations (20)
Other
- Novartis Investigative Site - Athens
- Novartis Investigative Site - Pátrai
- Novartis Investigative Site - Thessaloniki
- Novartis Investigative Site - Cagliari
- Novartis Investigative Site - Genova
- Novartis Investigative Site - Milan
- Novartis Investigative Site - Naples
- Novartis Investigative Site - Rome
- Novartis Investigative Site - Beirut
- Novartis Investigative Site - Ampang Selangor
- Novartis Investigative Site - Kuala Lumpur
- Novartis Investigative Site - Taipei
- Novartis Investigative Site - Bangkok
- Novartis Investigative Site - Adana
- Novartis Investigative Site - Ankara
- Novartis Investigative Site - Istanbul
- Novartis Investigative Site - Izmir
California
- Children's Hospital & Research Center Oakland - Oakland
Illinois
- Children's Memorial Hospital/Division of Hematology/Oncology - Chicago
New York
- New York Presbyterian Hospital/Weill Medical College of Cornell University - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2008-11 |
| Est. Completion | 2012-06 |
| Phase | Phase 2 |
What the finished NCT00873041 record still lists
NCT00873041 is an interventional study that assigns participants to a tested intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% higher).
The record links to 1 condition, with Non-transfusion Dependent Thalassemia appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00873041 names 20 study sites across 4 states, led by Other, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT00873041 about?
NCT00873041 is a clinical study titled "Efficacy and Safety of Deferasirox in Non-transfusion Dependent Thalassemia Patients With Iron Overload and a One Year Open-label Extension Study". CICL670A2209: This study will evaluate the safety and efficacy of deferasirox in non-transfusion dependent thalassemia patients with iron overload. Patients will be treated either with active treatment (deferasirox) or placebo for 12 months (core study phase). Patients who complete the core study ph...
What is the current status of trial NCT00873041?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 166 participants. The study started on 2008-11. Estimated completion is 2012-06.
What conditions does trial NCT00873041 study?
This clinical trial studies the following conditions: Non-transfusion Dependent Thalassemia.
What interventions are being tested in trial NCT00873041?
The interventions under investigation include: placebo (DRUG), deferasirox (DRUG).
Who is sponsoring clinical trial NCT00873041?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00873041 being conducted?
This trial has 20 study locations across California, Illinois, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00873041's enrollment target sits among peer trials
166 406th of 2000 higher than 1,591 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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