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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 is a Phase 2 study of Non-transfusion Dependent Thalassemia that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 166 participants. The trial reports 20 study locations across 4 states.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00873041
The ClinicalTrials.gov registry entry for NCT00873041 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 166 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.
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