Post-marketing Surveillance Protocol Number; CETB115G1401

Revolade Tablets Specified Drug-use Survey (Pediatric Aplastic Anemia Naive to Treatment with Anti-thymocyte Immunoglobulin

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2031230694

Enrollment

Registered

2024-03-12

Start date

2024-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Aplastic Anemia Naive to Treatment with Anti-thymocyte Immunoglobulin

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients whose legally acceptable representative has given written consent for cooperation in this survey prior to enrollment in this survey 2.Patients aged >=6 years and <18 years at the start of treatment with this product 3.Pediatric patients with AA who receive this product for the first time in combination with ATG after the approval of additional dosage and administration for "ATG-naive pediatric patients with AA"

Exclusion criteria

Exclusion criteria: 1.Patients who have received ATG without concomitant use of this product 2.Patients with congenital AA 3.Patients with suspected or confirmed diagnosis of MDS at the start of treatment with this product 4.Patients who have received any drug products containing the same ingredient as this product (including investigational products)

Design outcomes

Primary

Measure	Time frame
-Safety endpoints -Occurrence of serious adverse events	—

Contacts

Public ContactNovartis Direct

Novartis Pharma. K.K.

sm.pms@novartis.com+81-120003293

Outcome results