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Trial record 16 of 46 for:    thalidomide myeloma | Recruiting, Not yet recruiting, Available Studies

Efficacy and Safety of Low Dose Thalidomide in Thalassemia Intermedia

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 : August 29, 2018
Information provided by (Responsible Party):
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 Intermedia Drug: Thalidomide Oral Product Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Low Dose Thalidomide in Thalassemia Intermedia Patients of Pakistan
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : December 2018

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 1.5mg/kg/day (range 1-2mg/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: 1-2mg/kg/day

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

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed thalassemia intermedia patients, >5 years of age

Exclusion Criteria:

  • Those with active systemic comorbidity, with past personal or family history of thrombophilia and recent splenectomy

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: Blood Diseases Clinic Identifier: NCT03651102     History of Changes
Other Study ID Numbers: TI
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
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 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