Long Term Follow-up Observational Study After Clinical Trials of AMG531 (Romiplostim) in Patients With Untreated Aplastic Anemia
Study Details
Study Description
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 therapy-naïve patients with aplastic anemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- 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
- The duration of hematological response, and the presence or absence of occurrence of new chromosomal abnormality or transformation to AML/MDS. [52, 78, 104, 130, 156, 182, 208, 234, 260 weeks]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients whose written consent to participate in this research was obtained among patients registered for Study 531-003/531-004
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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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kanazawa University, College of Medical Pharmaceutical and Health Sciences, School of Medicine, Department of Hematology | Kanazawa | Ishikawa Prefecture | Japan | 920-0934 |
Sponsors and Collaborators
- Kyowa Kirin Co., Ltd.
Investigators
- Principal Investigator: Hirohito Yamazaki, Kanazawa University Hospital, Blood Transfusion Department
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 531-005