A Study of the Safety and Effectiveness of Eltrombopag in Combination With Immunosuppressive Therapy (IST) in Korean Pediatric Patients With Treatment Naïve Severe Aplastic Anemia

Part of paid clinical trials in East Hanover, New Jersey.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07415083
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Study Details

The aim of this study was to investigate the safety, tolerability, and effectiveness of eltrombopag in combination with immunosuppressive therapy (IST) in real world practice in pediatric patients with severe aplastic anemia (sAA) in Korea. The study used data over a 6-month period extracted from patients' medical charts (electronic medical records) starting from the initiation of eltrombopag treatment.

Key Dates

Start date
Jun 21, 2023
Status verified
Feb 2026
Primary completion
Feb 25, 2025
Completion
Feb 25, 2025

Study Design

Enrollment
13 participants (actual)

Arms

  • Arm: Eltrombopag and IST Treatment Cohort
    Pediatric patients with sAA who received first-line eltrombopag in combination with IST.

Primary Outcome Measure

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
NovartisEast HanoverNew Jersey07963-

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