Clinical Experience of Thalidomide in Thalassemic Patients
Status:
Completed
Trial end date:
2021-01-31
Target enrollment:
Participant gender:
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 change in liver and spleen size of beta-thalassemia patients on the
combination therapy
A single-arm non-randomized trial to evaluate the efficacy and safety of combination therapy
of hydroxyurea and thalidomide in beta-thalassemia patients. It was a twelve months study.
Participants were monitored for six months on Hydroxyurea alone and then the combination
therapy of hydroxyurea and thalidomide for another six months. Findings of physical
examination, vital signs, laboratory, and ultrasound findings were recorded at baseline,
during and end of the study.
Sample Size and Population This study included 135 Beta-thalassemia patients.