Efficacy and Safety of Thrombopoietin In Patients With Severe and Very Severe Aplastic Anemia

Efficacy and Safety of Thrombopoietin In Patients With Severe and Very Severe Aplastic Anemia

Efficacy and Safety of Recombinant human thrombopoietin in patients with severe aplastic anemia and very severe aplastic anemia, a randomized, double-blind, placebo-controlled, II phase, multi-center clinical research.

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Inclusion Criteria:

• Able to provide written informed consent
• Have severe or very severe aplastic anemia

Exclusion Criteria:

• Have diagnosis of Fanconi anemia
• Have infection not adequately responding to appropriate therapy
• Have Paroxysmal Nocturnal Hemoglobinuria (PNH) clone size in neutrophils of greater than or equal to 50%
• Have creatinine and/or blood urea nitrogen (BUN) ≥2 times the upper limit of normal
• Have serum bilirubin ≥ 1.5 times the upper limit of normal, or ≥4.0 times the upper limit of normal if the patient has been treated with Anti-Thymocytes globulin（ATG） within three weeks of screening.
• Have glutamic-oxaloacetic transaminase （AST） and/or glutamic-pyruvic transaminase （ALT） ≥ 3 times the upper limit of normal
• Are female and are nursing or pregnant or are unwilling to take oral contraceptives or refrain from pregnancy if of childbearing potential
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or greater
• Have had other Thrombopoietin (TPO-R) agonists medication in the previous 4 weeks.