CTRI/2024/03/063966RecruitingPhase 2
‘An Open-Label, Single-Arm Interventional Study to Evaluate the Safety and Efficacy of Romiplostim in Danazol Resistant/ Intolerant Inherited Bone Marrow Failure Syndromes’ - RISE
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Patients with IBMFS including Fanconi anemia, dyskeratosis congenita causing cytopenias Hb less than 8 gram per decilitre, ANC less than 500 cells or Platelet count less than 30,000 per microlitre or bone marrow cellularity less than 25 percent and with danazol resistance or intolerance
Exclusion Criteria
- •Known hypersensitivity or past use of Romiplostim, history of thrombosis, patients with IBMF with co-existing myelodysplasia or malignancies and organ dysfunction; presence of FANCD mutation
Investigators
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