Revolade Tablets Specified Drug-use Survey
Revolade Tablets Specified Drug-use Survey (Pediatric Aplastic Anemia Naive to Treatment With Anti-thymocyte Immunoglobulin, CETB115G1401)
Novartis Pharmaceuticals
10 participants
Jul 17, 2024
OBSERVATIONAL
Conditions
Summary
This is a multicenter, single-arm, non-interventional study (NIS) to confirm the safety and efficacy of eltrombopag in Anti-Thymocyte Globulin (ATG) treatment naive pediatric patients with aplastic anemia (AA).
Eligibility
Inclusion Criteria3
- Patients whose legally acceptable representative has given written consent for cooperation in this survey prior to enrollment in this survey
- Patients aged ≥ 6 years and \< 18 years at the start of treatment with eltrombopag
- Pediatric patients with AA who receive eltrombopag for the first time in combination with ATG after the approval of additional dosage and administration for "ATG-naïve pediatric patients with AA"
Exclusion Criteria4
- Patients who have received ATG without concomitant use of eltrombopag
- Patients with congenital AA
- Patients with suspected or confirmed diagnosis of myelodysplastic syndrome (MDS) at the start of treatment with eltrombopag
- Patients who have received any drug products containing the same ingredient as eltrombopag (including investigational products)
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Interventions
This is an observational study. There is no treatment allocation. After confirming that patients are fulfilling the eligibility criteria, patients will be registered in this survey.
Locations(17)
View Full Details on ClinicalTrials.gov
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NCT06287268