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Eltrombopag vs Standard Front Line Management for Newly Diagnosed Immune Thrombocytopenia (ITP) in Children

NCT03939637 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2025-07-29

Study results available
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Summary

This is an investigator initiated, multicenter, open label, randomized phase 3 study for subjects with newly diagnosed ITP from ages 1 to less than 18 years old.

Conditions

Interventions

DRUG

Eltrombopag

Starting dose for eltrombopag will be based on manufacturer recommendations, and drug will be titrated to effect per guidelines. * Children 1 to 5 years: Initial: 25 mg once daily * Children ≥6 years and Adolescents: Initial: 50 mg once daily (25 mg once daily for patients of East-Asian ethnicity \[e.g., Chinese, Japanese, Korean, Taiwanese\]) Dose should be titrated based on platelet response. Maximum dose: 75 mg once daily.

DRUG

Steroids

Prednisone/Prednisolone 4mg/kg/day (Max 120 mg/day) x 4 day

DRUG

IVIG

IVIG 1 g/kg x1 (no steroids for pre-medication or adjunctive therapy)

DRUG

Rho(D) Immune Globulin

Anti-D globulin 75 mcg/kg x1 (no steroids for pre-medication or adjunctive therapy)

Sponsors & Collaborators

Principal Investigators

  • Amanda Grimes, MD · Baylor College of Medicine - Texas Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-02
Primary Completion
2024-04-17
Completion
2025-02-26
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 NCT03939637 on ClinicalTrials.gov