This is a multicenter, randomized, double-blind, and open-label, placebo-controlled phase II clinical study. In order to evaluate the effectiveness and safety of trappa ethanolamine tablets combined with ciclosporin in the treatment of patients with non-severe aplastic anemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
78
Trappa ethanolamine tablets combined with ciclosporin
Placebo combined with ciclosporin
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
RECRUITINGFull hematological response rate
Time frame: About 13 weeks from the first medication to the evaluation.
Partial hematological response rate and total hematological response rate
Time frame: About 13 weeks from the first medication to the evaluation
Hematological response rate
Time frame: About 26 weeks from the first medication to the evaluation
The time required for the first hematological response
Time frame: About 26 weeks from the first medication to the evaluation
Changes in platelet count relative to the baseline of each visiting point of view
Time frame: About 26 weeks from the first medication to the evaluation
Changes in hemoglobin relative to the baseline of each visiting point of view
Time frame: About 26 weeks from the first medication to the evaluation
Changes in absolute neutrophil count relative to the baseline of each visiting point of view
Time frame: About 26 weeks from the first medication to the evaluation
Changes in reticulocyte count relative to the baseline of each visiting point of view
Time frame: About 26 weeks from the first medication to the evaluation
Cumulative proportion of patients who need blood transfusion
Time frame: About 26 weeks from the first medication to the evaluation
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Cumulative total amount of platelet transfusions
Time frame: About 26 weeks from the first medication to the evaluation
Cumulative amount of red blood cell infusions
Time frame: About 26 weeks from the first medication to the evaluation
Cumulative proportion of patients with disease progression
Time frame: About 26 weeks from the first medication to the evaluation