Phase 3 N=84 Randomized Double-blind Treatment

Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema

Angioedema

Bottom Line

View on ClinicalTrials.gov: NCT00097695 ↗

Enrolled (actual)

Serious AEs

2.9%

Results posted

Dec 2013

Primary outcome: Primary: Time to Onset of Symptom Relief (TOSR) — 2.5; 4.6 Hours — p=0.142

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Icatibant (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Shire
Primary completion: Jul 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Onset of Symptom Relief (TOSR)	2.5; 4.6	0.142
SECONDARY Time to Regression (Start of Improvement) According to Patient	0.8; 16.9	< 0.001 sig
SECONDARY Time to Almost Complete Symptom Relief	8.5; 19.4	= 0.079

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 (HAE).

Eligibility Criteria

Inclusion Criteria

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 Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00097695). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.