Not actual patients.
Study designs
HYMPAVZI has been studied in the BASIS clinical trial and the ongoing BASIS KIDS clinical trial
BASIS
The BASIS study included people ages 12 and older with hemophilia A or B, with or without inhibitors
The efficacy of HYMPAVZI for patients 12 years and older was established in 116 people with hemophilia A or B without inhibitors in the phase 3 BASIS study. The study consisted of a 6-month observational period (when the people were taking either on-demand factor replacement treatment or routine factor-based prophylactic treatment) followed by a 12-month active treatment phase with HYMPAVZI.
Participants
adults and adolescent males ages 12+ with severe hemophilia A or moderately severe to severe hemophilia B without inhibitors
routine factor-based prophylaxis participants
on-demand factor-based treatment participants
BASIS KIDS
BASIS KIDS is an ongoing trial that is studying HYMPAVZI in children, including those ages 6 to less than 18 with hemophilia A or B, with or without inhibitors
BASIS KIDS study overview—with or without inhibitors
The efficacy of HYMPAVZI was established in 57 children and adolescents ages 6 to less than 18 years of age with severe hemophilia A or moderately severe to severe hemophilia B, with or without inhibitors, in the BASIS KIDS study. The study consisted of a 12-month active treatment phase with HYMPAVZI. BASIS KIDS is an ongoing clinical study. Inhibitor participants with historic routine bypass therapy prophylaxis were not part of prespecified primary efficacy analysis, but were included in the safety analyses.
Participants
children and adolescents ages 6 to less than 18 with severe hemophilia A or moderately severe to severe hemophilia B, with and without inhibitors
Participants without inhibitors
Participants with inhibitors
51 adults and adolescents entered the observational phase. The efficacy of HYMPAVZI for patients 12 years and older was established in 48 people with hemophilia A or B with inhibitors. The study consisted of a 6-month observational period (when people were either taking on-demand or prophylactic treatment with bypassing agents) followed by a 12-month active treatment phase with HYMPAVZI. Inhibitor participants with historic routine bypass therapy prophylaxis were not part of prespecified primary efficacy analysis, but were included in the safety analyses.
Participants
adult and adolescent males ages 12+ with severe hemophilia A or moderately severe to severe hemophilia B with inhibitors
on-demand bypassing agent therapy participants
routine bypassing agent prophylaxis participants
BASIS KIDS
BASIS KIDS is an ongoing trial that is studying HYMPAVZI in children, including those ages 6 to less than 18 with hemophilia A or B, with or without inhibitors
BASIS KIDS study overview—with or without inhibitors
The efficacy of HYMPAVZI was established in 57 children and adolescents ages 6 to less than 18 years of age with severe hemophilia A or moderately severe to severe hemophilia B, with or without inhibitors, in the BASIS KIDS study. The study consisted of a 12-month active treatment phase with HYMPAVZI. BASIS KIDS is an ongoing clinical study. Inhibitor participants with historic routine bypass therapy prophylaxis were not part of prespecified primary efficacy analysis, but were included in the safety analyses.
Participants
children and adolescents ages 6 to less than 18 with severe hemophilia A or moderately severe to severe hemophilia B, with and without inhibitors
Participants without inhibitors
Participants with inhibitors
HYMPAVZI has been studied in 2 clinical trials. See study results.
