Safety and Effect of HbF Inducers in Beta Thalassemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares two groups of beta thalassemia patients. The experimental group receives low-dose thalidomide plus hydroxyurea daily for 12 months, with monitoring for safety and efficacy. Outcomes include hemoglobin levels, number of blood transfusions, and quality of life, with adverse events recorded at each follow-up. The control group receives standard care focused on transfusion requirements. Adults and children with confirmed beta thalassemia are eligible, with exclusions including pregnancy and certain comorbid conditions. The trial is led by Riphah International University in Rawalpindi, Pakistan.

Why it matters

Who can join: the full rules

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

Where it's running

• Riphah International University
  Rawalpindi, Punjab Province, Pakistan Recruiting

Study contacts

• Principal investigator: Fariha Sardar, MBBS, FCPS — Riphah International University, Rwp
• Study coordinator: Fariha Sardar, MBBS, FCPS
• Email: doc.fariha@yahoo.com
• Phone: +923335517877

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.