This is a multicenter, randomized, double-blind, parallel, placebo-controlled phase II clinical study. It is planned to recruit 74 patients with acquired thrombotic thrombocytopenic purpura (TTP). To evaluate the efficacy and safety of Anfibatide as an adjuvant therapy for plasma exchange in patients with acquired TTP.
The study will consist of 3 periods: screening(up to 7 days), treatment and follow-up(up to 3 months). Subjects are assigned in a 1:1 ratio to Anfibatide or placebo during plasma exchange with the use of a computerized randomization schedule. The administration is 5 IU/60kg intravenous infusion and 0.002 IU/kg/h continuous intravenous infusion. Plasma exchange as the main treatment method is performed daily on the 5th day of solstice and then adjusted to every other day. Fresh frozen plasma(FFP)and cryoprecipitate-reduced plasma are preferred. Subjects will receive the study drug immediately after daily plasma exchange.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
74
5 IU/60kg intravenous infusion follow by 0.002 IU/kg/h continuous intravenous infusion
5 IU/60kg intravenous infusion follow by 0.002 IU/kg/h continuous intravenous infusion
Shanghai Ruijing Hospital
Shanghai, Shanghai Municipality, China
Time to response of treatment
Time to response of treatment ,defined by a recovery of platelets ≥100\*10\^9/l
Time frame: up to 21days
Remission rate
Number of subjects with remission
Time frame: up to 21days
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