Revolade Tablets Specified Drug-use Survey
ConditionAplastic Anemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-17
SponsorNovartis Pharmaceuticals
About this trial
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 criteria
Qualifiers
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"
Disqualifiers
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)
Trial design
Treatments tested in this trial
- eltrombopag
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov