Status:
COMPLETED
Thalidomide and Hydroxyurea Combination in β-Thalassemia Patients
Lead Sponsor:
Children's Hospital Karachi
Conditions:
Thalassemia, Beta
Eligibility:
All Genders
2-50 years
Phase:
PHASE2
PHASE3
Brief Summary
Objectives Primary objective: • To determine the efficacy and safety of the combination therapy of Hydroxyurea and thalidomide in beta-thalassemia patients. Secondary objective: • To determine the...
Detailed Description
This study is conducted to evaluate the long-term efficacy and safety of the combination therapy of hydroxyurea and thalidomide in beta-thalassemia patients. Monotherapy of Hydroxyurea was sustained ...
Eligibility Criteria
Inclusion
- Patients with clinical and genetic diagnoses of β-thalassemia major and intermedia
- Patients who showed partial response or a decline in response to hydroxyurea
- Patients who are not candidates for the bone marrow transplant procedure
Exclusion
- Married Patients
- Patients with comorbidities such as liver, cerebrovascular, cardiovascular, or kidney diseases
- Patients allergic to the drug ingredients
- Patients with mental disorders
- Patients who are enrolled in other clinical trials
- Patients with a history of venous or arterial thrombosis
Key Trial Info
Start Date :
July 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2023
Estimated Enrollment :
603 Patients enrolled
Trial Details
Trial ID
NCT06153784
Start Date
July 7 2020
End Date
July 30 2023
Last Update
December 1 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital Karachi
Karachi, Sindh, Pakistan