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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eltrombopag | ATG treatment naïve pediatric patients with AA in routine clinical practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eltrombopag | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of serious adverse events | Occurrence of serious adverse events to be provided | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events and adverse drug reactions leading to treatment discontinuation | Occurrence of adverse events and adverse drug reactions leading to treatment discontinuation to be provided | Up to 1 Year |
| Occurrence of adverse events and adverse drug reactions applicable to safety specifications (hepatic dysfunction and hematopoietic malignancies) |
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Inclusion Criteria:
Exclusion Criteria:
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The survey will be conducted in pediatric patients with Aplastic anemia (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."
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +81337978748 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Recruiting | Nagoya | Aichi-ken | 453-8511 | Japan | |
| Novartis Investigative Site |
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| ID | Term |
|---|---|
| D000741 | Anemia, Aplastic |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000080983 | Bone Marrow Failure Disorders |
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| ID | Term |
|---|---|
| C520809 | eltrombopag |
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Occurrence of adverse events and adverse drug reactions applicable to safety specifications (hepatic dysfunction and hematopoietic malignancies) |
| Up to 1 year |
| Occurrence of clonal evolution | Occurrence of clonal evolution [cytogenetic abnormalities, myelodysplastic syndrome (MDS), Acute Myeloid Leukemia (AML), and paroxysmal nocturnal hemoglobinuria (PNH)] | Up to 1 year |
| Hematologic response status | Hematologic response status to be provided | Up to 1 year |
| Change over time from baseline in platelet count | Change over time from baseline in platelet count to be provided | Baseline, 1 year |
| Change over time from baseline in hemoglobin | Change over time from baseline in hemoglobin to be provided | Baseline, 1 year |
| Change over time from baseline in neutrophil count | Change over time from baseline in neutrophil count to be provided | Baseline, 1 year |
| Change over time from baseline in reticulocyte count | Change over time from baseline in reticulocyte count to be provided | Baseline, 1 year |
| Change over time from baseline in transfusion dependence | Change over time from baseline in transfusion dependence to be provided | Baseline, 1 year |
| Change over time from baseline in transfusion volume | Change over time from baseline in transfusion volume to be provided | Baseline, 1 year |
| Recruiting |
| Nagoya |
| Aichi-ken |
| 4668560 |
| Japan |
| Novartis Investigative Site | Recruiting | Toyoake | Aichi-ken | 4701192 | Japan |
| Novartis Investigative Site | Recruiting | Chiba | Chiba | 260 8677 | Japan |
| Novartis Investigative Site | Recruiting | Amagasaki | Hyōgo | 660 8550 | Japan |
| Novartis Investigative Site | Recruiting | Kobe | Hyōgo | 6500047 | Japan |
| Novartis Investigative Site | Recruiting | Matsumoto | Nagano | 3908621 | Japan |
| Novartis Investigative Site | Recruiting | Shimajiri-Gun | Okinawa | 901-1303 | Japan |
| Novartis Investigative Site | Recruiting | Izumi | Osaka | 5941101 | Japan |
| Novartis Investigative Site | Recruiting | Osaka | Osaka | 5340021 | Japan |
| Novartis Investigative Site | Recruiting | Sakai | Osaka | 590-0197 | Japan |
| Novartis Investigative Site | Recruiting | Saitama | Saitama | 3308777 | Japan |
| Novartis Investigative Site | Recruiting | Ohtsu | Shiga | 5202192 | Japan |
| Novartis Investigative Site | Recruiting | Chuo Ku | Tokyo | 1048560 | Japan |
| Novartis Investigative Site | Recruiting | Ōta-ku | Tokyo | 143 8541 | Japan |
| Novartis Investigative Site | Recruiting | Setagaya-ku | Tokyo | 1578535 | Japan |
| Novartis Investigative Site | Recruiting | Wakayama | Wakayama | 641-8510 | Japan |
| D001855 | Bone Marrow Diseases |