Real-world Outcomes of Aplastic Anemia Patients Treated With Eltrombopag: A Medical Claims Database Study
Completed
Conditions studied: Anemia, Aplastic
In brief
The main goal of this study was to investigate the effectiveness and safety of eltrombopag (ETB) when compared to other treatments in Japanese aplastic anemia (AA) patients using data from the Medical Data Vision (MDV) hospital-based database.
Key facts
- Study ID
- NCT06991894
- Run by
- Novartis Pharmaceuticals
- People needed
- 2517
- Starts
- 2021-07-14
- Expected to finish
- 2024-05-17
- Last updated by the study team
- 2025-05-28
Who can join
Age: 15 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with:
- At least one confirmed diagnosis of AA registered during the baseline period, or
- At least one confirmed diagnosis of idiopathic thrombocytopenic purpura (International Classification of Diseases, 10th Revision [ICD10] code: D69.3) registered before the index date and at least one confirmed diagnosis of AA during the follow-up period.
- Had at least 6 months of continuous enrolment prior to the index date.
- Confirmed diagnosis was defined as having ≥1 inpatient or ≥2 outpatient claims with a relevant ICD-10 code and without any doubtful flag.
- Continuous enrolment (being continuously followed in the database) was defined as having at least one claim every semester.
You may not qualify if…
- Not receiving ATG, CSA, ETB or romiplostim (ROM) during the selection period,
- Had a diagnosis of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), myelofibrosis, other hematological malignancies, or cataract before the index date.
- Inclusion and exclusion criteria for the effectiveness population:
- Inclusion criteria:
- Had at least one confirmed diagnosis of AA registered before the index date,
- Had at least one procedure for any type of transfusion such as red blood cell transfusion, platelet transfusion, or granulocyte transfusion registered during the baseline period or within 4 weeks after the index date,
- Had at least 6 months of continuous enrolment prior to the index date,
- Had at least a 6-month follow-up period.
- Exclusion criteria:
- Not receiving ATG, CSA, ETB or ROM during the selection period,
- Had at least one prescription of ATG, CSA, ETB or ROM before the index date,
- Had a diagnosis of AML, CMML or other hematological malignancies before the index date.
Where it is running
- Novartis — East Hanover, New Jersey, United States
Full record on ClinicalTrials.gov
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