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Combination Therapy With Danazol, Prednisolone, and Thalidomide for Thalidomide-Refractory Transfusion-Dependent β-Thalassemia
Sponsor: Khyber Medical University Peshawar
Summary
This study will compare two treatments for children with beta-thalassemia who need regular blood transfusions and have not responded well to thalidomide. One group will continue thalidomide alone. The other group will receive thalidomide plus danazol and prednisolone. The study will check whether the combination treatment reduces the need for blood transfusions, raises hemoglobin levels, and is safe. About 172 children aged 5 to 15 will be assigned by chance to one of the two groups. They will be followed for 9 to 12 months.
Official title: Safety and Efficacy of Combination Therapy (Danazol + Prednisolone + Thalidomide) in Thalidomide-Refractory Transfusion-Dependent β-Thalassemia Patients: A Prospective Randomized Controlled Clinical Trial
Key Details
Gender
All
Age Range
5 Years - 15 Years
Study Type
INTERVENTIONAL
Enrollment
172
Start Date
2026-10-12
Completion Date
2027-05-20
Last Updated
2026-10-21
Healthy Volunteers
No
Conditions
Interventions
Thalidomide
Initial oral capsule dose is 1 to 5 mg/kg taken once daily at night, with adjustments made every 2 to 4 weeks based on response and tolerance. The treatment is administered in both arms for a duration of 9 to 12 months.
Danazol
Oral capsule of 100 mg taken three times daily, continuously for 30 days per cycle. This medication is administered only in the combination arm.
Prednisolone
Oral tablet of 5 mg twice daily for 10 days each month, only administered in the combination arm.
Locations (1)
Pak International Medical College
Peshawar, Khyber Pakhtunkhwa, Pakistan