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Study of Romiplostim(AMG531) in Subjects With Aplastic Anemia | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

Study of Romiplostim(AMG531) in Subjects With Aplastic Anemia

Phase 2/3 Study of Romiplostim(AMG531) in Subjects With Aplastic Anemia Refractory to or Ineligible for Immunosuppressive Therapy

NCT02773290•Kyowa Kirin Co., Ltd.

View on ClinicalTrials.gov

Summary

The objective of this study is to evaluate the efficacy of romiplostim administered once weekly to Aplastic Anemia (AA) patients with thrombocytopenia refractory to or ineligible for immunosuppressive therapy in Japan and Korea. Safety and pharmacokinetics of romiplostim after repeated administration will also be assessed.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of Aplastic Anemia (AA) confirmed by peripheral blood and bone-marrow examinations, etc.
•Refractory to at least one course of immunosuppressive therapy including horse or rabbit anti-human thymocyte immunoglobulin (ATG); or ineligible for ATG treatment and refractory to cyclosporin (CyA)
•Thrombocytopenia defined as a platelet count of ≤ 30 × 10\^9/L
•Preserving main organ function as a result of screening as follows;
•* Total bilirubin: \< 1.5 times the upper limit of the laboratory normal range
•* Alanine aminotransferase: \< 3.0 times the upper limit of the laboratory normal range
•* Aspartate aminotransferase: \< 3.0 times the upper limit of the laboratory normal range
•* Creatinine value: ≤ 2.0 mg/dL
•An Eastern Cooperative Oncology Group performance status score of 0 to 2 at screening
•≥ 20 years of age at the time of obtaining informed consent
+1 more criteria

Exclusion Criteria

•Concurrent active infection not adequately responding to appropriate therapy
•Bone marrow reticulin grade of ≥ 2 based on the grading scale for reticulin indicated in Bone Marrow Pathology (2nd edition)
•Proportion of blasts in bone marrow \> 2%
•Previous or concurrent active malignancies, other than localized tumors diagnosed more than one year previously and treated surgically with curative intent (basal cell carcinoma; or surgically resected in situ carcinoma of the cervix with an apparent success of ≥ 12 months prior to enrollment; as well as other cancers which have not been treated and remained disease-free for at least 5 years before enrollment are eligible)
•Clinically significant cardiac disease (class III or IV of the New York Heart Association classification; unstable angina pectoris; myocardial infarction within 6 months before enrollment; cardiac disease accompanied by angioplasty or stenting within 6 months before enrollment; or clinically significant cardiac arrhythmias) or uncontrollable hypertension
•Arterial or venous thrombosis within one year before enrollment
•Positive for anti-human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C virus-RNA at screening
•Thrombocytopenia due to any other cause (e.g., myelodysplastic syndrome, idiopathic thrombocytopenic purpura, or liver cirrhosis)
•Patients with acute myeloblastic leukemia or chronic myelomonocytic leukemia
•Concurrent occurrence of hemolytic predominant paroxysmal nocturnal hemoglobinuria (Hemolytic predominant is defined as lactate dehydrogenase \> 1.5 times the upper limit of the laboratory normal range)
+12 more criteria

Locations (3)

Kanazawa, Japan

Tokyo, Japan

Seoul, South Korea

Key Dates

Start Date

May 1, 2016

Primary Completion Date

November 14, 2017

Completion Date

July 28, 2020

Last Updated

July 16, 2024

Enrollment

ACTUAL participants

Conditions

Aplastic Anemia

Interventions

Romiplostim

BIOLOGICAL

Natural History of Acquired and Inherited Bone Marrow Failure Syndromes

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Severe Aplastic AnemiaTelomere Biology Disorders+1 more

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RECRUITINGPHASE2

Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis

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Severe Aplastic Anemia (SAA)Hypo-Plastic Myelodysplastic Syndrome (MDS)+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Romiplostim(AMG531) in Subjects With Aplastic Anemia

Inclusion Criteria

Exclusion Criteria

Natural History of Acquired and Inherited Bone Marrow Failure Syndromes

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