About the I.M.P.A.C.T. Clinical Studies

CSL Behring has recently sponsored two studies, one of which, I.M.P.A.C.T. 1, is now closed. Both use human C1-INH concentrate to treat acute attacks of HAE, which has been used to treat HAE patients in Europe for more than two decades.

• I.M.P.A.C.T. 1: Used human C1-INH concentrate in acute attacks of the abdomen or face in people with type I HAE
• I.M.P.A.C.T. 2: Uses human C1-INH concentrate in acute attacks in people with type I HAE

I.M.P.A.C.T. Participants Were Assigned to 1 of 3 Groups: Neither subjects nor the researchers know which patients are in which groups. But no patient is denied C1-INH concentrate when they are in the throes of an attack.

I.M.P.A.C.T. 1 was a "double-blind" study. In a double-blind study, some subjects receive placebo and some receive medication, but neither the subjects nor the investigator know which patients receive which medications. However, this does NOT mean that those in the placebo group never receive C1-INH.

I.M.P.A.C.T. 2 is not a blinded study, but an "open-label" study. All subjects receive the human C1-INH. Moreover, unlike the I.M.P.A.C.T. 1 study, the medication can be used for different types of attacks.

In order to have therapies available for your children and your children's children, CSL Behring must prove the safety and efficacy of human C1-INH to the satisfaction of the United States Food and Drug Administration.

In order to have therapies available for your children and your children's children, CSL Behring must prove the safety and efficacy of human C1-INH to the satisfaction of the United States Food and Drug Administration. Find out more information about clinical trials.