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
This trial does not accept healthy volunteersQualifiers
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 population
The survey will be conducted in pediatric patients with Aplastic anemia (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."
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
eltrombopag
Other interventionThis 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: eltrombopag1 intervention
Trial outcomes
Primary outcomes
1
Occurrence of serious adverse events
Occurrence of serious adverse events to be provided
Time frame
Up to 1 yearSecondary outcomes
1
Occurrence of adverse events and adverse drug reactions leading to treatment discontinuation
Occurrence of adverse events and adverse drug reactions leading to treatment discontinuation to be provided
Time frame
Up to 1 Year2
Occurrence of adverse events and adverse drug reactions applicable to safety specifications (hepatic dysfunction and hematopoietic malignancies)
Occurrence of adverse events and adverse drug reactions applicable to safety specifications (hepatic dysfunction and hematopoietic malignancies)
Time frame
Up to 1 year3
Occurrence of clonal evolution
Occurrence of clonal evolution \[cytogenetic abnormalities, myelodysplastic syndrome (MDS), Acute Myeloid Leukemia (AML), and paroxysmal nocturnal hemoglobinuria (PNH)\]
Time frame
Up to 1 year4
Hematologic response status
Hematologic response status to be provided
Time frame
Up to 1 yearSponsors and contacts
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Source ClinicalTrials.gov