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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. Identifier: NCT03651102
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : January 30, 2020
Information provided by (Responsible Party):
Muhammad Tariq Masood Khan, Blood Diseases Clinic

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.

Condition or disease Intervention/treatment Phase
Thalassemia Drug: Thalidomide Oral Product Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Low Dose Thalidomide in Transfusion Dependent Thalassemia Patients of Pakistan
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia
Drug Information available for: Thalidomide

Arm Intervention/treatment
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.
Drug: Thalidomide Oral Product
Dosage: 1-3mg/kg/day

Primary Outcome Measures :
  1. Haemoglobin Level [ Time Frame: 6-24 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Months to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03651102

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Contact: Muhammad Tariq M Khan, MBBS, PhD +92-300-5888867
Contact: Muhammad Tariq H Khan, MBBS, MPhil +92-333-9355661

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Blood Diseases Clinic Recruiting
Peshawar, Khyber Pakhtukhwa, Pakistan, 0000
Contact: Muhammad Tariq M Khan    +92-300-5888867   
Sponsors and Collaborators
Blood Diseases Clinic
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Study Chair: Muhammad Tariq M Khan, MBBS, PhD Blood Diseases Clinic

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Responsible Party: Muhammad Tariq Masood Khan, Consultant Haematologist; Research Associate, Blood Diseases Clinic Identifier: NCT03651102    
Other Study ID Numbers: TI
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Muhammad Tariq Masood Khan, Blood Diseases Clinic:
Additional relevant MeSH terms:
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Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents