Status:
COMPLETED
Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema
Lead Sponsor:
Shire
Conditions:
Angioedema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the efficacy and safety of Icatibant, a bradykinin antagonist in the treatment of acute cutaneous and/or abdominal attacks in patients with hereditary angioedema...
Detailed Description
This Phase II/III study consisted of two parts: A controlled phase and An Open label extension(OLE) phase. The controlled phase describes the double blind part of the study and was intended to evaluat...
Eligibility Criteria
Inclusion
- Age above 18 years;
- Documented diagnosis of HAE Type I or II (confirmed complement 1 esterase inhibitor \[C1-INH\] deficiency);
- Current edema be in the cutaneous, abdominal and/or laryngeal areas;
- Current edema be moderate to severe according to the investigator's Symptom Score.
Exclusion
- Diagnosis of angioedema other than HAE, for example, acquired angioedema (AAE);
- Participation in a clinical trial of another investigational medicinal product (IMP) within the past month;
- Treatment with any pain medication since onset of the current edema attack;
- Treatment with replacement therapy, including C1-INH products (e.g. human C1-INH preparations), less than 3 days from onset of the current edema attack;
- Treatment with ACE inhibitors (e.g. Lotensin, Prinivil, Accupril);
- Evidence of severe, symptomatic coronary artery disease based on medical history or screening examination;
- Serious concomitant illnesses that the physician considers to be a contraindication for participation in the trial;
- Pregnancy and/or breast-feeding.
Key Trial Info
Start Date :
December 28 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2006
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00097695
Start Date
December 28 2004
End Date
July 17 2006
Last Update
June 9 2021
Active Locations (1)
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1
Georgetown University Hospital, Lombardi Cancer Center
Washington D.C., District of Columbia, United States, 20007-2197