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Thalidomide and Hydroxyurea Combination in β-Thalassemia Patients

NCT06153784 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 603

Last updated 2023-12-01

No results posted yet for this study

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. Participants were monitored for six months on Hydroxyurea alone and then the combination therapy of hydroxyurea and thalidomide was started. Findings of physical examination, vital signs, laboratory, and ultrasound findings were recorded at baseline, during, and end of the study.

The assessment of treatment outcomes was conducted at the 1-year, 2-year, and 3-year follow-up points during the combination therapy period, categorizing patients as either "good responders," "responders," or "non-responders."

Conditions

  • Thalassemia, Beta

Interventions

DRUG

Hydroxyurea and Thalidomide

Evaluation of hydroxyurea and thalidomide combination use in beta-thalassemia patients

Sponsors & Collaborators

  • Children's Hospital Karachi

    lead OTHER

Principal Investigators

  • Saqib H Ansari, Phd · Children's Hospital Karachi Sindh, Pakistan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-07
Primary Completion
2023-07-30
Completion
2023-07-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06153784 on ClinicalTrials.gov