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TPO-Mimetic Use in Children for Hematopoietic Failure

NCT04478227 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-07-30

No results posted yet for this study

Summary

This is an open label, prospective Pilot interventional study will investigate the safety and efficacy of Romiplostim, thrombopoietin (TPO) mimetic, in children (ages: 0 to 21 years) with broad scope of bone marrow failure disorders including acquired and inherited conditions as a first line of therapy along with standard of care.

Conditions

  • Bone Marrow Failure Disorders
  • Aplastic Anemia
  • Thrombocytopenia
  • Refractory Cytopenia of Childhood
  • Myelodysplastic Syndrome(MDS)

Interventions

DRUG

Romiplostim

Nplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Anjali Sharathkumar

    lead OTHER

Principal Investigators

  • Anjali A. Sharathkumar, MBBS, MD, MS · University of Iowa

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-18
Primary Completion
2024-01-18
Completion
2024-01-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04478227 on ClinicalTrials.gov