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

• Status: Completed
• Trial end date: 2006-07-25
• Target enrollment: 0
• Participant gender: All

Summary

Primary Outcome Measures:

The primary endpoint was the time to onset of symptom relief of the first attack in the double blind phase. H0: λ icatibant/λ tranexamic acid =1 versus H1: λ icatibant/λ tranexamic acid ≠1 Where: λ icatibant refers to the hazard rate under icatibant and λ tranexamic acid refers to the hazard rate under tranexamic acid.

Secondary Outcome Measures:

• Additional efficacy assessments (Time to Almost Complete Symptom Relief)

• Safety and tolerability

• Pharmacoeconomics

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Bradykinin; Icatibant; Tranexamic Acid

Criteria

Inclusion Criteria:

• Age above 18 years;

• Documented diagnosis of HAE Type I or II (confirmed C1-INH deficiency);

• Current edema in the cutaneous, abdominal and/or laryngeal areas;

• Current edema moderate to severe according to the investigator's Symptom Score.

Exclusion Criteria:

• Diagnosis of angioedema other than HAE,

• 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 angioedema attack

• Treatment with replacement therapy, including C1-INH products, less than 3 days before onset of the current angioedema attack

• Treatment with Tranexamic acid replacement therapy within a week before onset of the current angioedema attack

• Treatment with ACE inhibitors

• Contraindications for Tranexamic acid

• Evidence of coronary artery disease based on medical history or Screening examination in particular unstable angina pectoris or severe coronary heart disease

• Congestive heart failure (class 3 and 4)

• Serum creatinine level of ≥ 250 μmol/L

• Serious concomitant illness that the investigator considered to be a contraindication for participation in the trial

• Pregnancy (as assessed prior to treatment) and/or breast-feeding