Trials / Completed
CompletedNCT00061763
Study of Deferasirox in Iron Overload From Beta-thalassemia Unable to be Treated With Deferoxamine or Chronic Anemias
Phase II Study of Safety & Efficacy of Deferasirox Given for 1 Year in Patients With Chronic Anemias and Transfusional Hemosiderosis Unable to be Treated With Deferoxamine
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 175 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the effects of the oral iron chelator Deferasirox on liver iron content after one year of treatment in patients with iron overload from repeated blood transfusions. Beta-thalassemia patients unable to be treated with deferoxamine or patients with rare chronic anemias such as Myelodysplastic Syndrome, Fanconi's Syndrome, Blackfan-Diamond Syndrome, and Pure Red Blood Cell Anemia are eligible for this study. Liver iron content will be measured by liver biopsy at the beginning of the study and after one year of treatment. However, those patients living in the San Francisco/Oakland area may have a SQUID in place of the liver biopsy if the biopsy is not medically possible for them. The SQUID is a non-invasive magnetic means to measure liver iron content.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Deferasirox |
Timeline
- Start date
- 2003-05-01
- Primary completion
- 2004-11-01
- First posted
- 2003-06-04
- Last updated
- 2017-08-22
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00061763. Inclusion in this directory is not an endorsement.