NCT07884773 Combination Therapy With Danazol, Prednisolone, and Thalidomide for Thalidomide-Refractory Transfusion-Dependent β-Thalassemia
| NCT ID | NCT07884773 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Khyber Medical University Peshawar |
| Condition | Beta-Thalassemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 172 participants |
| Start Date | 2026-10-12 |
| Primary Completion | 2027-04-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 172 participants in total. It began in 2026-10-12 with a primary completion date of 2027-04-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will compare two treatments for children with beta-thalassemia who need regular blood transfusions and have not responded well to thalidomide. One group will continue thalidomide alone. The other group will receive thalidomide plus danazol and prednisolone. The study will check whether the combination treatment reduces the need for blood transfusions, raises hemoglobin levels, and is safe. About 172 children aged 5 to 15 will be assigned by chance to one of the two groups. They will be followed for 9 to 12 months.
Eligibility Criteria
Inclusion Criteria: * Age 5 to 15 years with confirmed transfusion-dependent beta-thalassemia major. * Documented non-response to adequately dosed thalidomide therapy for at least 6 months. * Pre-transfusion hemoglobin less than 9.0 g/dL with continued transfusion dependence (more than 2 units per month). * Adequate baseline clinical and laboratory assessment for safe study treatment. * Stable transfusion and iron-chelation regimen according to the protocol. * Written informed consent from parent/legal guardian and age-appropriate assent from the participant, with willingness to comply with study procedures and follow-up. Exclusion Criteria: * Previous allogeneic hematopoietic stem cell or bone marrow transplantation. * Diabetes mellitus or clinically significant uncontrolled metabolic disease. * Active severe infection or uncontrolled hepatic, renal, or cardiovascular disease. * Significant pre-existing peripheral neuropathy or history of clinically significant thromboembolic disease. * Known hypersensitivity to any study medication.
Contact & Investigator
Syeda Nayab Imtiaz, MBBS
PRINCIPAL INVESTIGATOR
Institute of Pathology and Diagnostic Medicine, Khyber Medical University, Peshawar
Frequently Asked Questions
Who can join the NCT07884773 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 15 Years, studying Beta-Thalassemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07884773 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 172 participants.
Is NCT07884773 currently recruiting?
Yes, NCT07884773 is actively recruiting participants. Contact the research team at dr.nayabimtiaz@hotmail.com for enrollment information.
Where is the NCT07884773 trial being conducted?
This trial is being conducted at Peshawar, Pakistan.
Who is sponsoring the NCT07884773 clinical trial?
NCT07884773 is sponsored by Khyber Medical University Peshawar. The principal investigator is Syeda Nayab Imtiaz, MBBS at Institute of Pathology and Diagnostic Medicine, Khyber Medical University, Peshawar. The trial plans to enroll 172 participants.