Status:
ACTIVE_NOT_RECRUITING
Long Term Follow-up Observational Study After Clinical Trials of AMG531 (Romiplostim) in Patients With Untreated Aplastic Anemia
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Aplastic Anemia
Eligibility:
All Genders
Brief 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 the...
Eligibility Criteria
Inclusion
- Patients whose written consent to participate in this research was obtained among patients registered for Study 531-003/531-004
- Of the patients who died before their consent to participate in this research was obtained among those registered for Study 531-003/531-004, patients whose legally authorized representatives such as their family had given the consent or patients whose legally authorized representatives had not refused in the disclosure of information by opt-out
- Of the patients who died before their consent to participate in this research was obtained among those registered for Study 531-003/531-004, patients, patients for whom the consent process exemption was approved by the Ethics Review Committee, etc. of the participating medical institutions at the participating medical institutions in the countries without the opt-out system
Exclusion
- Patients who are judged by the investigator or sub-investigator to be unfavorable for participation in this research
Key Trial Info
Start Date :
May 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2027
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04870346
Start Date
May 10 2021
End Date
June 30 2027
Last Update
September 11 2025
Active Locations (1)
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1
Kanazawa University, College of Medical Pharmaceutical and Health Sciences, School of Medicine, Department of Hematology
Kanazawa, Ishikawa-ken, Japan, 920-0934