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Recruiting NCT07673302

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

Conditions: Thalassemia

Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 240
Sponsor: Riphah International University

Location: Riphah International University Rawalpindi Punjab Province

Summary

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

Eligibility Criteria

Inclusion criteria: * 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 Exclusion criteria: * 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07673302). StuddyBuddy aggregates publicly available trial information.