Safety and Efficacy of Hemoglobin F Inducers in Patients With Beta Thalassemia

Recruiting now · Not applicable

Conditions studied: Thalassemia

In brief

The aim of this study is to determine the safety and therapeutic effect of HbF inducers (combination therapy: thalidomide and hydroxyurea) on beta thalassemia patients. The main objectives of this study are: * To determine the therapeutic efficacy of HbF inducers (combination therapy: thalidomide and hydroxyurea) on hemoglobin level and blood transfusion in beta thalassemia patients. * To determine the safety of HbF inducers (combination therapy: thalidomide and hydroxyurea) in beta thalassemia patients * To determine effect of HbF inducers (combination therapy: thalidomide and hydroxyurea) on quality of life of beta thalassemia patients

Key facts

Study ID: NCT07673302
Run by: Riphah International University
People needed: 240
Starts: 2026-06-20
Expected to finish: 2027-06-19
Last updated by the study team: 2026-08-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Confirmed diagnosis of Beta thalassemia Major (BTM) ascertained by Hemoglobin Electrophoresis or HPLC report performed pre-transfusion or genetic testing profile (comprising PCR or HBB gene sequencing) suggestive of β-thalassemia syndrome.
All ages and both genders will be included
Written informed consent

You may not qualify if…

Pregnancy or unwilling to follow contraception or planning conception (Enrolled female patients will be strictly advised to avoid pregnancy during the study period and until 6 months after thalidomide withdrawal.
Hemoglobinopathies other than beta thalassemia
History of neurological problems
Inability to regularly follow up

Where it is running

Riphah International University — Rawalpindi, Punjab Province, Pakistan (enrolling)

Full record on ClinicalTrials.gov

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