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Clinical Trials/CTRI/2024/03/063966
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

INDIAN COUNCIL OF MEDICAL RESEARCH0 sites0 target enrollmentStarted: TBDLast updated:

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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