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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04870346
Other study ID # 531-005
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 10, 2021
Est. completion date June 30, 2024

Study information

Verified date August 2023
Source Kyowa Kirin Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 45
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Japan Kanazawa University, College of Medical Pharmaceutical and Health Sciences, School of Medicine, Department of Hematology Kanazawa Ishikawa Prefecture

Sponsors (1)

Lead Sponsor Collaborator
Kyowa Kirin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hematological response at 2 years after the start of romiplostim treatment in Study 531-003/531-004 2 years
Primary Hematological response at up to 5 years after the start of romiplostim treatment in Study 531-003/531-004 5 years
Secondary 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
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