Status:
UNKNOWN
Study Of Efficacy,Safety of Combined Deferasirox and Deferiprone Versus Combined Deferiprone and Desferal In Conditions of Iron Overload
Lead Sponsor:
Ain Shams University
Conditions:
Beta-thalassemia Major
Sickle Cell Disease
Eligibility:
All Genders
6-18 years
Phase:
PHASE2
PHASE3
Brief Summary
Interventional Allocation: Randomized Endpoint Classification: Safety/Efficacy Study of combined chelation therapy Masking: Open Label Primary Purpose: Treatment of transfusional iron overload Primar...
Detailed Description
Study population: 1. Beta-thalassemia major patients; Patients with high iron stores Serum ferritin consistently \> 2500 mcg/l and or increasing trend over previous 12 months Liver iron \>14 mg/g dry...
Eligibility Criteria
Inclusion
- Subjects with transfusional iron overload secondary to thalassemia major , sickle cell disease showing up-trend in SF aged 6 Years or older, may participate after Approval of Ethical committee giving written informed consent.
- Subjects must have a serum ferritin greater than \>2500 ng/mL, a platelet count greater than 100,000/mm3, and a serum creatinine within the normal range.
- A woman of childbearing potential must have a negative serum pregnancy test at screening. She must use a medically acceptable form of birth control during the study and for 1 month afterward.
- The subjects must also have a level of understanding and willingness to cooperate with the confinement and procedures described in the consent form and scheduled by the study site. In addition, he/she must be able to provide voluntary written informed consent.
Exclusion
- Subjects with a past history of agranulocytosis, history of clinically significant gastrointestinal, renal, hepatic ALT \> 10 times high normal, OR \> 50% increase of serum creatinine from basal value, pulmonary or cardiovascular disease. Patients with a history of tuberculosis, epilepsy, psychosis, glaucoma or any other condition, which in the opinion of the investigators, would jeopardize the safety of the subject or impact the validity of the study results.
- Subjects with HIV positive or have active HCV.
- A history of serious immunologic hypersensitivity to any medication, such as anaphylaxis or angioedema.
- Participation in a previous investigational drug study within the 30 days preceding screening..
- Women who are pregnant, or breast-feeding.
- Current alcohol or drug abuse.
- An inability to adhere to the designated procedures and restrictions of this protocol.
- Subjects receiving warfarin, digoxin, or anti-arrhythmic or anti-seizure medications.
- Subjects with a known allergy to Exjade or DFP that prevents chronic administration.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01511848
Start Date
February 1 2012
End Date
February 1 2013
Last Update
February 6 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pediatric Hematology clinic, Ain Shams University
Cairo, Egypt