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Clinical Trials/IRCT20221129056655N1
IRCT20221129056655N1RecruitingPhase 2

Assessment of efficacy and safety of Romiplostim in immunosuppressive-refractory children with severe acquired aplastic anemia

Shiraz University of Medical Sciences0 sites24 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 2
Status
Recruiting
Enrollment
24
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
1 month to 18 years (—)
Sex
All

Inclusion Criteria

  • •Children up to the age of 18 years with non-severe transfusion-dependent AA, severe and very severe acquired aplastic anemia who are ineligible to be treated with IST (ATG plus cyclosporine) or are refractory to IST are enrolled.

Exclusion Criteria

  • •1.Patients with inherited aplastic anemia
  • •2.Diagnosed as having acute myeloid leukemia (AM)L or myelodysplastic syndrome (MDS)
  • •3.Having active malignancies, or having a history of the treatment of malignancies within 5 years prior to informed consent.
  • •4.Concurrent paroxysmal nocturnal hemoglobinuria
  • •5.History of chromosome aberrations discovered in bone marrow cells.
  • •6.Bone marrow fibrosis based on reticulin stain
  • •7.Planned hematopoietic stem cell transplantation during the study

Investigators

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