No serious or severe adverse events were considered by the investigator to be related to Cinryze, and no adverse events led to treatment discontinuation. There was no evidence of human immunodeficiency virus (HIV) or viral hepatitis transmission or development of clinically relevant anti-C1 INH antibodies in these studies.Design of Sub-Group Analysis of Prospective DataForty-six children and adolescents ranging in age from two to 17 years received a total of 2,237 infusions of Cinryze across two randomized, placebo-controlled studies and their open-label extensions. One of the studies and its extension evaluated the use of Cinryze in acute HAE attacks, and the other evaluated its use in prophylaxis. In the pivotal acute-attack treatment trial, patients who presented to the study site within 4 hours after onset of a moderate or severe acute attack of the abdomen, face, or external genitalia were randomly assigned to intravenous infusions of placebo or Cinryze 1000 U. The pivotal prophylaxis trial consisted of 2 consecutive 12-week treatment periods during which patients received study medication for preventing HAE attacks. Patients were randomly assigned to receive intravenous infusions of 1000 U Cinryze or placebo every 3 to 4 days.
Sub-Group Analysis Of Data From Pediatric Patients With Hereditary Angioedema Published In The Journal Of Pediatrics
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