Clinical Experience of Thalidomide in Thalassemic Patients

• Status: Completed
• Trial end date: 2021-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Karachi
• Treatments: Hydroxyurea; Thalidomide

Criteria

Inclusion Criteria:

1. Patients with clinical and genetic diagnosis of β-thalassemia major and intermedia

2. Patients who showed partial response or a decline in response to hydroxyurea

3. Patients who are not the candidates for the bone marrow transplant procedure.

Exclusion Criteria:

1. Married Patients

2. Patients with comorbidities such as liver, cerebrovascular, cardiovascular, or kidney diseases

3. Patients allergic to the drug ingredients

4. Patients with mental disorders

5. Patients who are enrolled in other clinical trials

6. Patients with a history of venous or arterial thrombosis