At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 654 enrolled
Drug / intervention
Thalidomide and Hydroxyureadrug
Likely dose
Thalidomide and Hydroxyurea 4mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of Low Dose Thalidomide in Transfusion Dependent Thalassemia Patients of Pakistan
In Brief
A Phase 3 clinical trial evaluating Thalidomide and Hydroxyurea for Thalassemia. Completed, enrolled 654 participants across 1 site.
Detailed Summary
Thalidomide is known to have hypnosedative, immuno-modulatory and anti-angiogenic effects. The drug is widely used in several neoplastic disorders (e.g. multiple myeloma and malignant melanoma), inflammatory conditions (e.g. Crohn's disease) and skin disorders (e.g. leprosy). Thalidomide has been successfully used in adult thalassemia patients. The current study explores its role in transfusion-dependent thalassemia patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThalassemia
CountriesPakistan
CollaboratorsUniversity of Peshawar
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartJan 2018
First PostedAug 2018
Primary CompletionNov 2021
Study CompletionMar 2022
TodayJul 2026
First PostedAug 29, 2018
Enrollment StartJan 1, 2018
Primary CompletionNov 30, 2021
Study CompletionMar 1, 2022
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 7.8 years ago
Interventions
Thalidomide and Hydroxyureadrug
Dosage: Thalidomide 1-4mg/kg/day, Hydroxyurea 10-20mg/kg/day