One-year follow up of Thalassemia patients with Deferiprone (GPO-L-ONE) Chelation Therapy
Phase 4
Completed
- Conditions
- Adult thalassemia patients with iron overload.thalassemia,iron overload
- Registration Number
- TCTR20110000020
- Lead Sponsor
- none
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 87
Inclusion Criteria
Adult thalassemia patients with serum ferritin level was above 1,000 ug/L. None of the patients were pregnant, without elevated aspartate transaminase (AST) or alanine transaminase (ALT) (exceeding 250 IU/L), and an absolute neutrophil count (ANC) of less than 1,500 cells/mm3. Bone marrow disease including malignancy, aplastic anemia and myelodysplastic syndrome were also excluded. No patients used other iron chelating agents. All patients had normal ophthalmic examinations and audiometry tests.
Exclusion Criteria
transaminase levels were elevated more than three times or exceeding 250 IU/L, ANC less than 1,500 cells/mm3, severe infection, drug allergy.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method serum ferritin reduction 12 months serum ferritin level
- Secondary Outcome Measures
Name Time Method adverse effects 12 months history taking and physical examination