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

NCT ID: NCT04870346

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-10

Study Completion Date

2027-06-30

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.

Detailed Description

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Conditions

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Aplastic Anemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hirohito Yamazaki

Role: PRINCIPAL_INVESTIGATOR

Kanazawa University Hospital, Blood Transfusion Department

Locations

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Kanazawa University, College of Medical Pharmaceutical and Health Sciences, School of Medicine, Department of Hematology

Kanazawa, Ishikawa-ken, Japan

Site Status

Countries

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Japan

Other Identifiers

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531-005

Identifier Type: -

Identifier Source: org_study_id

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