drugset / Trial / NCT06490601

Long Term Beta Thalassemia Treatment: Findings From The Extension Period

NCT06490601

RandomizedParallel-groupOpen-labelTreatment

Summary

The project, titled "Long Term Beta Thalassemia Treatment: Findings From The Extension Period Of Phase 2 Clinical Trial," aims to compare the efficacy and safety of combination therapy (thalidomide and hydroxyurea) versus thalidomide alone. The study, lasting three years, is a Phase 2 single-center, open-label interventional study with a sample size of 30 participants aged 8-35 years. It includes specific inclusion and exclusion criteria for participant selection. Data will be collected through clinical interviews and medical records and analyzed using(Statistical Package for the Social Sciences. This project aims to enhance beta thalassemia treatment strategies, focusing on reducing transfusion dependency and improving patient quality of life.

Timeline

Start
2022-04-01
Primary completion
2024-04-01
Completion
2025-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydroxyurea Other / unclassified 500 mg
Comparator Thalidomide Other / unclassified 100 mg

Indications