Sanofi

The results showed that: (1) in terms of the main endpoints, Compared with placebo + standard nursing regimen, Cablivi combined with standard nursing regimen significantly shortened the time to normalize platelet count (p ≤ 0.01); at any particular time point during the study period, the possibility of reaching normal platelet count in Cablivi treatment group was. The placebo group was 1.55 times as much as the placebo group. (2) compared with placebo + standard nursing regimen, Cablivi combined with standard nursing regimen significantly reduced aTTP-related deaths, aTTP recurrence or at least one major thromboembolism event by 74 percent throughout the study period (p < 0.001). (3) during the whole study period, compared with placebo + standard nursing regimen, Cablivi combined with standard nursing regimen significantly reduced the recurrence of aTTP by 67% (p < 0.001). (4) throughout the study period, there were 0 refractory diseases in the Cablivi group and 3 refractory diseases in the placebo group, although there was no significant difference (p ≤ 0.06). (5) compared with the placebo group, the normalization of three organ injury markers (lactate dehydrogenase, cardiac troponin I, serum creatinine) occurred earlier in Cablivi group (p did not detect significant due to stratified statistical test). (6) the use of plasma exchange in Cablivi group was significantly lower than that in the placebo group (mean 5.8 days vs 9.4 days, a decrease of 38%). And stay in intensive care units (a decrease of 65 percent) and hospitals (a decrease of 31 percent) is even shorter. (7) the safety of Cablivi is consistent with previous reports and accords with its mechanism of action, including the increased risk of bleeding; the most common bleeding-related adverse events are epistaxis and gingival bleeding.