Efficacy and Safety of Low Dose Thalidomide in Transfusion Dependent Thalassemia

Efficacy and Safety of Low Dose Thalidomide in Transfusion Dependent Thalassemia Patients of Pakistan

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03651102

Acronym

Thal-Thalido

Enrollment

654

Registered

2018-08-29

Start date

2018-01-01

Completion date

2022-03-01

Last updated

2022-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thalassemia

Keywords

Thalidomide, Thalassemia

Brief 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.

Interventions

DRUGThalidomide and Hydroxyurea

Dosage: Thalidomide 1-4mg/kg/day, Hydroxyurea 10-20mg/kg/day

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

Healthy volunteers

Inclusion criteria

* Transfusion dependent thalassemia patients refractory to Hydroxyurea

Exclusion criteria

* Those with active systemic comorbidity, with past personal or family history of thrombophilia, recent fracture or recent major surgery

Design outcomes

Primary

Measure	Time frame	Description
Haemoglobin Level	6-24 months	mg/dL
Response Rate (Excellent, Good, Partial and No response)	6-24 months	—
Adverse Effects	6-24 months	—

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026