A retrospective observational study of fostamatinib in patients with idiopathic thrombocytopenic purpura

A retrospective observational study of fostamatinib in patients with idiopathic thrombocytopenic purpura - A retrospective observational study of fostamatinib in patients with idiopathic thrombocytopenic purpura

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000057096

Enrollment

Registered

2025-02-20

Start date

2025-02-14

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

idiopathic thrombocytopenic purpura

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria can be enrolled in this study; 1.Patients with idiopathic thrombocytopenic purpura 2.Patients who received fostamatinib at least once in accordance with its package insert after April 2023 3.Patients aged 18 years or older at giving their consent or at day of publication of opt-out document 4.Patients who give their consent in written form by their free will after understanding of the contents of this study, or patients who do not refuse to use their medical records in this study by opt-out in case that they do not continue visiting Fujisawa City Hospital at day of the initiation of this study (at day of IRB approval)

Exclusion criteria

Exclusion criteria: Patients who fall into any of the following criteria cannot be enrolled; 1. Patients who refuse to use their medical records in this study 2. Patients who need regal representatives

Design outcomes

Primary

Measure	Time frame
Proportion of patients who achieved platelet of 30,000 /microliter or higher and twice or more compared with the baseline value at least once within 24 weeks after initiation of fostamatinib	—

Secondary

Measure	Time frame
1. Proportion of patients whose platelet is 50,000 /microliter or higher at 1, 2, 4, 8, 12, 16, 20, and 24 weeks after initiation of fostamatinib 2. Proportion of patients whose platelet is 30,000 /microliter or higher and twice or more compared with the baseline value at 1, 2, 4, 8, 12, 16, 20, and 24 weeks after initiation of fostamatinib 3. Proportion of patients whose platelet is 100,000 /microliter or higher at 1, 2, 4, 8, 12, 16, 20, and 24 weeks after initiation of fostamatinib 4. Time course of platelet response in each patient 5. Duration required to achieve platelet of 50,000 /microliter or higher and duration maintaining it 6. Time course of platelet in each patient 7. Frequency of hemorrhage events from the initiation of fostamatinib to 24 weeks after	—

Measure

Time frame

1. Proportion of patients whose platelet is 50,000 /microliter or higher at 1, 2, 4, 8, 12, 16, 20, and 24 weeks after initiation of fostamatinib 2. Proportion of patients whose platelet is 30,000 /microliter or higher and twice or more compared with the baseline value at 1, 2, 4, 8, 12, 16, 20, and 24 weeks after initiation of fostamatinib 3. Proportion of patients whose platelet is 100,000 /microliter or higher at 1, 2, 4, 8, 12, 16, 20, and 24 weeks after initiation of fostamatinib 4. Time course of platelet response in each patient 5. Duration required to achieve platelet of 50,000 /microliter or higher and duration maintaining it 6. Time course of platelet in each patient 7. Frequency of hemorrhage events from the initiation of fostamatinib to 24 weeks after

—

Countries

Japan

Contacts

Public ContactHiroki Takayama

EviPRO Co., Ltd. Clinical Study Support Division

htak@evipro.co.jp03-5829-4110

Outcome results