CompletedNot Applicable

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

United States13 participantsStarted 2023-06-21

Plain-language summary

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.

Who can participate

Age range2 Years – 17 Years

SexALL

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Inclusion criteria

✓. Male or female pediatric patients aged ≥2 years and \<18 years at the time of initiating eltrombopag and IST treatment.
✓. Subjects diagnosed with sAA and treated with eltrombopag in combination with IST as first-line therapy, based on the physician's decision in accordance with locally approved prescribing information at the time of data collection.
✓. Subjects whose analytical index date (start date of eltrombopag administration) was at least 6 months prior to the data extraction date.

What they're measuring

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: Up to 6 months

Trial details

NCT IDNCT07415083

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-02-25

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