Last Update: Aug 09, 2024
Revolade Tablets Specified Drug-use Survey (Pediatric Aplastic Anemia Naive to Treatment With Anti-thymocyte Immunoglobulin, CETB115G1401)
ClinicalTrials.gov Identifier:
NCT06287268
Novartis Reference Number:CETB115G1401
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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

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.

Aplastic Anemia
Recruiting
10
Jul 17, 2024
Mar 28, 2029
All
6 Years - 17 Years (Child)

Interventions

Other

eltrombopag

This 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.

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)

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

Osaka,534-0021,Japan

Novartis Investigative Site

Recruiting

Shimajiri-Gun,Okinawa,901-1303,Japan

Novartis Investigative Site

Recruiting

Saitama,330 8777,Japan

Novartis Investigative Site

Recruiting

Izumi-city,Osaka,594-1101,Japan

Novartis Investigative Site

Recruiting

Nagoya,Aichi,453-8511,Japan

Novartis Investigative Site

Recruiting

Osaka Sayama,Osaka,589 8511,Japan

Novartis Investigative Site

Recruiting

Toyoake city,Aichi,470 1192,Japan

Novartis Investigative Site

Recruiting

Chuo ku,Tokyo,104 8560,Japan

Novartis Investigative Site

Recruiting

Amagasaki city,Hyogo,660 8550,Japan

Novartis Investigative Site

Recruiting

Ota-ku,Tokyo,143 8541,Japan

Worldwide Contacts

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Novartis Pharmaceuticals

+81337978748