Eltrombopag in Chronic ITP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-01-01

Brief Summary

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This study aims to evaluate the efficacy of eltrombopag on the platelet count in pediatric patients with chronic immune thrombocytopenia.

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Detailed Description

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Conditions

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Immune Thrombocytopenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Eltrombopag

Thrombopietic agent approved for its efficacy in chronic immune thrombocytopenia in pediatric patients

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Pediatric patients with chronic ITP aged 1 to 17 years.
2. Platelet count is less than 30×109 per liter.
3. Patients neither have had spontaneous resolution of the thrombocytopenia nor responded to corticosteroids and/or IV immunoglobulin.

Exclusion Criteria

1. Patients with clinical and/or laboratory evidence of hepatotoxicity/liver decompensation (Hepatotoxicity due to eltrombopag is defined as increased serum alanine aminotransferase ≥3 times the upper limit of normal (ULN), aspartate aminotransferase ≥3 ULN, alkaline phosphatase \>1.5 ULN, total bilirubin \>1.5 ULN)
2. Patients with history of thrombotic/thromboembolic events.

Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No