Study Description
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.
Interventions
eltrombopag
Eligibility Criteria
Inclusion Criteria:
- 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"
Exclusion Criteria:
- 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)
Study Location
Novartis Investigative Site
Recruiting
Toyoake city,Aichi,470 1192,Japan
Novartis Investigative Site
Recruiting
Osaka Sayama,Osaka,589 8511,Japan
Novartis Investigative Site
Recruiting
Amagasaki city,Hyogo,660 8550,Japan
Novartis Investigative Site
Recruiting
Osaka,534-0021,Japan
Novartis Investigative Site
Recruiting
Chuo ku,Tokyo,104 8560,Japan
Novartis Investigative Site
Recruiting
Ota-ku,Tokyo,143 8541,Japan
Novartis Investigative Site
Recruiting
Izumi-city,Osaka,594-1101,Japan
Novartis Investigative Site
Recruiting
Saitama,330 8777,Japan
Novartis Investigative Site
Recruiting
Kobe,Hyogo,650-0047,Japan
Novartis Investigative Site
Recruiting
Setagaya-ku,Tokyo,157-8535,Japan
Novartis Investigative Site
Recruiting
Matsumoto,Nagano,390-8621,Japan
Novartis Investigative Site
Recruiting
Shimajiri-Gun,Okinawa,901-1303,Japan
Novartis Investigative Site
Recruiting
Nagoya,Aichi,453-8511,Japan
Worldwide Contacts
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