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

Study Overview
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Brief Summary
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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.

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

Conditions
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Aplastic Anemia

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of hematological response, and the presence or absence of occurrence of new chromosomal abnormality or transformation to AML/MDS. | Duration of hematological response in patients who achieved hematologic response at the completion of Study 531-003/531-004 Time courses of Hb level (g/dL) Time courses of platelet count (/μL) Time courses of neutrophil count (/μL) Presence or absence of platelet blood cell transfusion Presence or absence of red blood cell transfusion Presence or absence of G-CSF product administration Dose level and administration period of cyclosporine A Presence or absence of transformation to MDS/AML Presence or absence of occurrence of new chromosome abnormality Time to the start of subsequent treatment or to death Overall survival | 52, 78, 104, 130, 156, 182, 208, 234, 260 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aplastic anemia