Status:
COMPLETED
Study of AMG531 (Romiplostim) in Patients With Aplastic Anemia
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Aplastic Anemia
Eligibility:
All Genders
20+ years
Phase:
PHASE2
PHASE3
Brief Summary
To evaluate the hematological responses based on the response assessment criteria defined in this study (the 531-004 response assessment criteria) when AMG531 is subcutaneously (SC)-administered with ...
Eligibility Criteria
Inclusion
- Voluntary signed informed consent to participate in the study;
- A diagnosis of AA confirmed by blood and bone-marrow examinations, etc.;
- Considered to require new treatment with immunosuppressive therapy provided that NSAA must be platelet or erythrocyte transfusion-dependent.
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1at screening;
Exclusion
- Previously treated with Anti-human thymocyte immunoglobulin (ATG), CsA, or Alemtuzumab;
- Diagnosed as having congenital AA (Fanconi anemia, congenital dyskeratosis, etc.);
- Diagnosed as having acute myelocytic leukemia (AML) or chronic myelomonocytic leukemia;
- Concurrent thrombocytopenia of other etiologies (e.g., myelodysplastic syndrome (MDS), idiopathic thrombocytopenic purpura (ITP), cirrhosis);
- Concurrent active infection not adequately responding to appropriate therapy;
- Concurrent clinically significant illness(es) items which are deemed by the Investigator to be likely to affect the study conduct and assessments.
- Having active malignancies, or having a history of treatment of malignancies within 5 years prior to informed consent.
- Concurrent paroxysmal nocturnal hemoglobinuria (PNH)
- Having Grade 2 or higher bone marrow reticulin based on Bone Marrow Pathology (2nd edition) ;
- History of chromosome aberrations discovered in bone marrow cells.
- Having blast cells \> 2% in bone marrow;
- Positive for anti-human immunodeficiency virus (HIV) antibody;
- Receiving prophylactic or therapeutic treatment for hepatitis type B
- Having hepatitis C virus (HCV) infection confirmed by HCV-RNA or other tests at screening.
- Planned hematopoietic stem cell transplantation during the study;
- Systemic treatment with any of the following medication for the treatment of AA within 4 weeks before Day 1:
- Anabolic steroids
- Corticosteroids;
- Pregnant or breastfeeding women, or women willing to become pregnant;
- Other conditions unsuitable for participation in the study in the opinion of the Investigator.
Key Trial Info
Start Date :
December 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04095936
Start Date
December 3 2019
End Date
October 29 2021
Last Update
May 26 2022
Active Locations (1)
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1
NTT Medical center Tokyo
Shinagawa, Tokyo, Japan