Last Update: Feb 19, 2026 Revolade Tablets Specified Drug-use Survey (Pediatric Aplastic Anemia Naive to Treatment With Anti-thymocyte Immunoglobulin, CETB115G1401) ClinicalTrials.gov Identifier: [NCT06287268](https://clinicaltrials.gov/ct2/show/NCT06287268) Novartis Reference Number:CETB115G1401 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") 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. Condition Aplastic Anemia Overall Status Recruiting Number of Participants10 Start Date Jul 17, 2024 Completion Date Oct 31, 2028 Gender All Age(s) 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) Japan #### Novartis Investigative Site Recruiting Matsumoto,Nagano,3908621,Japan #### Novartis Investigative Site Recruiting Wakayama,Wakayama,641-8510,Japan #### Novartis Investigative Site Recruiting Setagaya-ku,Tokyo,1578535,Japan #### Novartis Investigative Site Recruiting Chuo Ku,Tokyo,1048560,Japan #### Novartis Investigative Site Recruiting Ohtsu,Shiga,5202192,Japan #### Novartis Investigative Site Recruiting Saitama,Saitama,3308777,Japan #### Novartis Investigative Site Recruiting Sakai,Osaka,590-0197,Japan #### Novartis Investigative Site Recruiting Osaka,Osaka,5340021,Japan #### Novartis Investigative Site Recruiting Izumi,Osaka,5941101,Japan #### Novartis Investigative Site Recruiting Shimajiri-Gun,Okinawa,901-1303,Japan #### Novartis Investigative Site Recruiting Kobe,Hyōgo,6500047,Japan #### Novartis Investigative Site Recruiting Chiba,Chiba,260 8677,Japan #### Novartis Investigative Site Recruiting Toyoake,Aichi-ken,4701192,Japan #### Novartis Investigative Site Recruiting Nagoya,Aichi-ken,4668560,Japan #### Novartis Investigative Site Recruiting Ōta-ku,Tokyo,143 8541,Japan #### Novartis Investigative Site Recruiting Amagasaki,Hyōgo,660 8550,Japan #### Novartis Investigative Site Recruiting Nagoya,Aichi-ken,453-8511,Japan ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +81337978748](tel:+81337978748) Email: