Status:
UNKNOWN
Efficacy and Safety of Romiplostim Versus Eltrombopag in the Treatment of Thrombocytopenia in Patients With Wiskott-Aldrich Syndrome
Lead Sponsor:
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Conditions:
Wiskott-Aldrich Syndrome
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
Brief Summary
This is a prospective, open-label, randomized, two-arm clinical trial conducted to evaluate the safety and efficacy of romiplostim in comparison with eltrombopag in the treatment of thrombocytopenia i...
Detailed Description
Wiskott-Aldrich syndrome (WAS) is a life-threatening primary immunodeficiency associated with bleeding of variable severity due to severe thrombocytopenia. Considering that the hemorrhagic events are ...
Eligibility Criteria
Inclusion
- Genetically verified Wiskott-Aldrich syndrome
- Thrombocytopenia (platelet count \< 70 x 109/L)
- Age: under 18 years
- Subject/legal representative has signed written informed consent.
Exclusion
- Patients, who do not meet the inclusion criteria.
- Any prior history of arterial or venous thrombosis within the past year.
- Arm II (eltrombopag):
- abnormal hepatic function -elevated AST/ALT \> 1.5 times upper limit of normal within 4 weeks prior to enrollment
- Active colitis
Key Trial Info
Start Date :
November 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04371939
Start Date
November 5 2019
End Date
July 30 2023
Last Update
May 6 2020
Active Locations (1)
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1
Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology
Moscow, Russia, 117997