Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE)

PHASE3CompletedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

March 1, 2005

Primary Completion Date

July 25, 2006

Study Completion Date

July 25, 2006

Conditions
Hereditary Angioedema
Interventions
DRUG

Icatibant

Icatibant: a stable, synthetic decapeptide and specific BK B2 receptor antagonist.

DRUG

Tranexamic Acid

over encapsulated film tablet an anti-fibrinolytic agent,is used in some European countries for the treatment of acute oedema episodes and the continuous prophylaxis of HAE.

DRUG

Oral Placebo

hard capsule matched to tranexamic acid

DRUG

S.C. Placebo

solution for injection, matched to icatibant for injection

Trial Locations (1)

20123

Università degli Studi di Milano, Dipartimento di Medicina Interna, Milan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY