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.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* Patients who are judged by the investigator or sub-investigator to be unfavorable for participation in this research
Primary outcome measure(s)
Hematological response at 2 years after the start of romiplostim treatment in Study 531-003/531-004 — 2 years
Hematological response at up to 5 years after the start of romiplostim treatment in Study 531-003/531-004 — 5 years
Trial sites (1)
Facility
City
Region
Status
Kanazawa University, College of Medical Pharmaceutical and Health Sciences, School of Medicine, Department of Hematology
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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