Post-marketing Surveillance Protocol Number; CETB115G1401

JRCT ID: jRCT2031230694

Registered date:12/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pediatric Aplastic Anemia Naive to Treatment with Anti-thymocyte Immunoglobulin
• Date of first enrollment: 01/04/2024
• Target sample size: 10
• Study type: Observational

Outcome(s)

Primary Outcome

-Safety endpoints
-Occurrence of serious adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: < 18age old
• Gender: Both

Include 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"

Exclude 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)

Related Information

• Primary Sponsor: sato masayuki