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Revolade Tablets Specified Drug-use Survey (Pediatric Aplastic Anemia Naive to Treatment With Anti-thymocyte Immunoglobulin, CETB115G1401)
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).
The objective of this survey is to confirm the safety and efficacy of eltrombopag in ATG treatment naive pediatric patients with AA. Eltrombopag should be administered according to the dosage and administration specified in the latest version of the package insert. The observation period is 1 year (364 days) from the start of treatment with this product, regardless of whether treatment with eltrombopag is continued or not. However, if hematopoietic stem cell transplantation is performed within 1 year after the start of treatment with eltrombopag, the observation period shall be until the date of hematopoietic stem cell transplantation.
Age
6 - 17 years
Sex
ALL
Healthy Volunteers
No
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Toyoake, Aichi-ken, Japan
Novartis Investigative Site
Chiba, Chiba, Japan
Novartis Investigative Site
Amagasaki, Hyōgo, Japan
Novartis Investigative Site
Kobe, Hyōgo, Japan
Novartis Investigative Site
Matsumoto, Nagano, Japan
Novartis Investigative Site
Shimajiri-Gun, Okinawa, Japan
Novartis Investigative Site
Izumi, Osaka, Japan
Novartis Investigative Site
Osaka, Osaka, Japan
Start Date
July 17, 2024
Primary Completion Date
October 31, 2028
Completion Date
October 31, 2028
Last Updated
February 19, 2026
10
ESTIMATED participants
eltrombopag
OTHER
Novartis Pharmaceuticals
CONTACT
Lead Sponsor
Novartis Pharmaceuticals
NCT05012111
NCT03520647
Data Source & Attribution
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