IRCT2014122920051N1
Completed
Phase 3
A prospective single arm study to assess the efficacy and safety of deferasirox 20 mg/kg BID in transfusion dependent beta-thalassemia patients unresponsive to current treatment with doses > 35 mg/kg QD or with intolerance to single dose therapy
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Thalassemia.
- Sponsor
- ovartis
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion: Aged 2 years; Serum ferritin \>2000 ng/ml and unresponsive to current treatment with doses \> 35 mg/kg QD (decrease in ferritin level less than 10%); patients who did not tolerate single dose therapy due to adverse effects
- •Exclusion: Patients will be excluded from this trial if they have one of the following criteria: positive serology for HBS Ag , HCV Ab, HIV Ab. Abnormal liver or kidney function tests;An alanine aminotranferase (ALT) level greater than 250 U/L;serum creatinine level above the upper limit of normal, and a urinary protein\-creatinine ratio of greater than 0\.5 mg/mg); a history of ocular toxicity related to iron chelation therapy;uncontrolled systemic hypertention, a prolonged corrected QT interval; systemic infection within 10days prior to enrollment; gastrointestinal absorption problem ;Patients who found complication of chelation therapy during trial as well as breast feeding and pregnant women.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
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