CompletedNo phase
Real-world Outcomes of Aplastic Anemia Patients Treated With Eltrombopag: A Medical Claims Database Study
Key facts
- Who runs it
- Novartis Pharmaceuticals
- Where
- East Hanover, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 2,517 people enrolled
- Started
- 14 Jul 2021
- Ended
- 17 May 2024
- Type of study
- Observational, 2 groups
- Record updated
- 28 May 2025
Who can take part
- Age
- 15 years to 90 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
- 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
Who cannot take part
- Not receiving ATG, CSA, ETB or romiplostim (ROM) during the selection period,
- Not receiving ATG, CSA, ETB or 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:
- Had a diagnosis of AML, CMML or other hematological malignancies before the index date
- Had at least one prescription of ATG, CSA, ETB or ROM before the index date,
Other criteria
- Inclusion and exclusion criteria for the safety population:
Where in United States
- NovartisEast Hanover, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Anatomical Therapeutic Chemical (ATG)-free Cohort
Japanese patients with AA from the MDV database who received treatment with ciclosporin A (CSA) alone, ETB alone, or a combination of CSA and ETB.
- ATG-Inclusive Cohort
Japanese patients with AA from the MDV database who received one of the following treatment combinations: CSA and ATG or CSA and ETB and ATG.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Real-world Outcomes of Aplastic Anemia Patients Treated With Eltrombopag: A Retrospective Medical Claims Database Study (Eltrombopag for Aplastic Anemia)
- Record updated
- 28 May 2025