Phase 2
N=22
Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload
Thalassemia · Iron Overload
Bottom Line
View on ClinicalTrials.gov: NCT00901199 ↗Enrolled (actual)
22
Serious AEs
9.1%
Results posted
Aug 2021
Primary outcome: Primary: Efficacy of Combined Treatment With Deferasirox and Deferoxamine Over 12 Months — -6.2 mg/g
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Combo Chelation with Deferasirox (Exjade) and Deferoxamine (DFO) (Drug)
- Age
- Pediatric, Adult, Older Adult · 8+ yrs
- Sex
- All
- Sponsor
- Elliott Vichinsky
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Combined Treatment With Deferasirox and Deferoxamine Over 12 Months |
-6.2 | — |
| PRIMARY Change in Serum Creatinine During 12 Months Combined Chelation Therapy |
0.09 | — |
Summary
This is a pilot study looking at the safety and efficacy of giving combination chelation with deferasirox and deferoxamine. The hypothesis is that combination chelation is safe in decreasing overall iron in patients with thalassemia.
Eligibility Criteria
Inclusion Criteria
- Transfusion Dependent Thalassemia
- If iron between 5-15 mg/g dry liver by SQUID, subject must have a documented endocrinopathy or cardiac finding
- Older than 8 years
Exclusion Criteria
- Participating on another interventional clinical trial
Data sourced from ClinicalTrials.gov (NCT00901199). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.