Efficacy of Combination of Hdroxyurea and Thalidomide Over Hydroxyurea or Thalidomide in the Treatment of Transfusion Dependent Thalassemia in Children

NCT06299670 | Completed Phase 4 DMC

• 1 other identifier: 939
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to find out the efficacy of combined Hydroxyurea and thalidomide transfusion dependent thalassemia patients. The main objectives are to compare the level of Hb, Transfusion interval, serum ferritin level before \& after treatment between single and combination of thalidomide and HU. Researcher will compare the effectiveness of combined hydroxyurea and thalidomide and hydroxyurea and thalidomide alone. Participants will be divided in three groups: Group I: will take combination of HU and Thalidomide. Group II: Will take HU alone and Group III: Will take Thalidomide alone and outcome will be recorded.

Conditions

Transfusion-dependent Thalassemia

Keywords

Transfusion Dependent Thalassemia; Hydroxyurea; Thalidomide

Outcome Measures

Primary Outcomes (3)

• Change in Hb Level

  Change in Hb gm/dl after 3 month

  12 weeks after treatment initiation

• Change in Blood transfusion frequency

  Change in Blood transfusion frequency after 3 month

  12 weeks after treatment initiation

• Change in HbF

  Change in Hb F after 3 month

  12 weeks after treatment initiation

Secondary Outcomes (6)

• Adverse effect

  12 weeks from treatment initiation

• Change in Serum Ferritin level

  12 weeks after treatment initiation

• Change in SGPT level

  12 weeks from treatment initiation

• Change in serum bilirubin level

  12 weeks after initiation of treatment

• Change of Serum Creatinine level

  12 weeks after treatment initiation

Study Arms (3)

Thalidomide

EXPERIMENTAL

Patient getting Thalidomide

Drug: Thalidomide

Hydroxyurea

EXPERIMENTAL

Hydroxyurea

Drug: Hydroxy Urea

Combination

EXPERIMENTAL

combination of Thalidomide \& Hydroxyurea

Drug: Combinations

Interventions

Thalidomide DRUG

Patients will get only Thalidomide

Thalidomide

Hydroxy Urea DRUG

Patients will get only Hydroxyurea

Hydroxyurea

Combinations DRUG

Combination Of Thalidomide \& Hydroxyurea

Combination

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients diagnosed as transfusion dependent thalassemia
• Age ranged from 3-18 years
• Blood transfusion more than 1 year.
• no bleeding disorder

You may not qualify if:

• Active systemic co-morbidity,
• Past personal or family history of thrombophilia,
• Recent fracture or recent major surgery
• Use of drugs that might affect Hb levels 15 days before enrollment

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1000, Bangladesh

Location

Related Publications (22)

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MeSH Terms

Interventions

Thalidomide; Hydroxyurea

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Urea; Amides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2024
• First Posted: March 8, 2024
• Study Start: November 1, 2023
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)