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Efficacy and Safety of Low Dose Thalidomide in Transfusion Dependent Thalassemia (Thal-Thalido)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03651102
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Muhammad Tariq Masood Khan, Blood Diseases Clinic

Tracking Information
First Submitted Date  ICMJE August 24, 2018
First Posted Date  ICMJE August 29, 2018
Last Update Posted Date January 30, 2020
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2020)
Haemoglobin Level [ Time Frame: 6-24 months ]
mg/dL
Original Primary Outcome Measures  ICMJE
 (submitted: August 27, 2018)
Haemoglobin Level [ Time Frame: 6 months ]
mg/dL
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Low Dose Thalidomide in Transfusion Dependent Thalassemia
Official Title  ICMJE Efficacy and Safety of Low Dose Thalidomide in Transfusion Dependent Thalassemia Patients of Pakistan
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 younger thalassemia patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thalassemia
Intervention  ICMJE Drug: Thalidomide Oral Product
Dosage: 1-3mg/kg/day
Study Arms  ICMJE Experimental: Patients Receiving Thalidomide Therapy
All the study patients will be given thalidomide at an average dose of 2mg/kg/day (range 1-3mg/kg/day). The patients will be followed at 4 weeks interval by a haematologist for monitoring of potential side effects and for evaluation of clinical and laboratory response.
Intervention: Drug: Thalidomide Oral Product
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 26, 2020)
500
Original Estimated Enrollment  ICMJE
 (submitted: August 27, 2018)
100
Estimated Study Completion Date  ICMJE January 1, 2021
Estimated Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Transfusion dependent thalassemia patients

Exclusion Criteria:

  • Those with active systemic comorbidity, with past personal or family history of thrombophilia or history of splenectomy in the past 6 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Months to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Muhammad Tariq M Khan, MBBS, PhD +92-300-5888867 drtariqmsd@gmail.com
Contact: Muhammad Tariq H Khan, MBBS, MPhil +92-333-9355661 .tariq_razmian@yahoo.com
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03651102
Other Study ID Numbers  ICMJE TI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Muhammad Tariq Masood Khan, Blood Diseases Clinic
Study Sponsor  ICMJE Blood Diseases Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Muhammad Tariq M Khan, MBBS, PhD Blood Diseases Clinic
PRS Account Blood Diseases Clinic
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP