NCT07884773RecruitingPhase 3
Combination Therapy With Danazol, Prednisolone, and Thalidomide for Thalidomide-Refractory Transfusion-Dependent β-Thalassemia
Safety and Efficacy of Combination Therapy (Danazol + Prednisolone + Thalidomide) in Thalidomide-Refractory Transfusion-Dependent β-Thalassemia Patients: A Prospective Randomized Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 172 (estimated)
- First submitted
- 13 Oct 2026
- Start date
- 12 Oct 2026
- Primary completion date
- 12 Apr 2027
- Lead sponsor
- Khyber Medical University Peshawar
- Diseases
- Thalassaemia
- NCT number
- NCT07884773
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 172
- From 12 Oct 2026 to the primary completion date, 12 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous allogeneic hematopoietic stem cell or bone marrow transplantation.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 5 years to 15 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pak International Medical College Coordinator of this site? Confirm its status | Peshawar | Pakistan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.