Phase
Condition
Red Blood Cell Disorders
Aplastic Anemia
Anemia
Treatment
Cyclosporin A
rhTPO
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
aged ≥ 18 years, male and female; 2. patients with a clear diagnosis of NSAA who aredependent on transfusion therapy:
Meet the Camitta NSAA criteria;
accompanied by at least one of the following abnormalities: (1) dependence oncomponent blood transfusion therapy, at least one component blood transfusion every 8 weeks on average, and the duration of transfusion dependence ≥ 4 months, theindication of component blood transfusion: HGB ≤ 60g / L; (2) PLT ≤ 10 × 10 ^ 9 / L,or PLT ≤ 30 × 10 ^ 9 / L with a significant tendency to bleed; (3) neutrophils ≤ 0.5 × 10 ^ 9 / L.
Excluding other haematological and non-haematological diseases that causepancytopenia; 3. ECOG PS score 0-2, expected survival ≥ 3 months with follow-up; 4.functional levels of major organs must meet the following requirements: 1) Totalbilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); 2) alanineaminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN; 3) bloodcreatinine (Cr) ≤ 1.5 x ULN; 5. has not been treated with platelet receptor agonist (TPO-RA) analogues and other immunosuppressant analogues; 6. the subject is notsuitable or willing to receive haematopoietic stem cell transplantation therapy; 7.no history of serious heart, lung, liver, kidney and other important organs andendocrine system diseases; 8. Voluntarily enroll in the study, sign the informedconsent, have good compliance and willing to cooperate with the follow-up.
Exclusion
Exclusion Criteria:
have used other clinical investigational drugs within 4 weeks;
a history of primary myelodysplastic syndromes (MDS), primary paroxysmal sleephaemoglobinuria (PNH) and leukaemia, as well as congenital bone marrow failuresyndromes (IBMFS), such as Fanconi's anaemia (FA) and congenital dyskeratosis (DC)
history of cirrhosis or history of portal hypertension;
congestive heart failure, arrhythmia, peripheral arteriovenous thrombosis requiringmedication within 1 year prior to enrolment, or myocardial infarction or cerebralinfarction within 3 months prior to enrolment;
HIV infection;
severe autoimmune disease or immunodeficiency disease;
suffering from malignant tumour
severe mental disorders;
a known history of allergy to the drug components of this regimen;
in the opinion of the investigator, it is not appropriate to participate in thistrial, e.g., any other medical, social or psychological factors that may affectsafety or compliance with the study procedures.
Compliance with study procedures.
Study Design
Study Description
Connect with a study center
Peking Union Medical College Hospital
Beijing, Beijing 100730
ChinaSite Not Available

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