Not actual patients.
Trial design
Delivered bleed protection*
Trial overview
The efficacy and safety of HYMPAVZI was established in 116 hemophilia patients without inhibitors in the BASIS phase 3 study. The 18-month trial consisted of a 6-month observational period (when the patients were taking either "on-demand" factor replacement treatment or routine factor-based prophylactic treatment) followed by a 12-month active treatment period with HYMPAVZI.
*In the BASIS phase 3 study, the primary objective was to measure the annualized bleed rate (ABR) of treated bleeds vs on-demand factor-based treatment and vs factor-based prophylaxis after 12 months on HYMPAVZI. 92% reduction in treated bleeds on HYMPAVZI compared with on-demand factor-based treatment (3.18 ABR vs 38.00 ABR). 35% reduction in treated bleeds on HYMPAVZI compared with routine prophylaxis treatment (5.08 ABR vs 7.85 ABR). Individual results may vary.
Participants
adults and adolescent male participants ages 12+, with severe hemophilia A or B without inhibitors
routine factor-based prophylaxis participants
on-demand factor-based treatment participants