Clinical Trial

Long Term Follow-up Observational Study After Clinical Trials of AMG531 (Romiplostim) in Patients With Untreated Aplastic Anemia

Active, Not Recruiting
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Summary
To evaluate the long-term efficacy and safety after the end of romiplostim treatment by observation \[up to 5 years\] of patients who were registered for Study 531-003/531-004 in immunosuppressive therapy-naïve patients with aplastic anemia.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-04-28; most recent amendment 2025-09-09.
Status change: Enrolling by Invitation → Active, Not Recruiting 2024-08-01
Trial Details
NCT Number NCT04870346
Lead Sponsor Kyowa Kirin Co., Ltd.
Conditions Aplastic Anemia
Enrollment 36 participants
Start Date 2021-05-10
Primary Completion 2024-08-31 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-11