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OpenTrials
Completed

NCT Number: NCT03651102

Efficacy and Safety of Low Dose Thalidomide in Transfusion Dependent Thalassemia

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.

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Key information

Conditions

Thalassemia Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Blood Diseases Clinic

Peshawar, Khyber Pakhtukhwa, 0000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

thalidomide and hydroxyurea

Drug

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

Primary outcomes

  1. Haemoglobin Level

    Time frame: 6-24 months

    mg/dL

  2. Response Rate (Excellent, Good, Partial and No response)

    Time frame: 6-24 months

  3. Adverse Effects

    Time frame: 6-24 months

Sponsors and collaborators

Lead sponsor

Blood Diseases Clinic

Other

Collaborators

  • University of Peshawar

Registry information

Official study title

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

Acronym: Thal-Thalido

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Aug 29, 2018
Registry last updated
Mar 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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