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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomised Double Blind, Controlled, Parallel Group, Multicentre Study of a Subcutaneous Formulation of Icatibant Versus Oral Tranexamic Acid for the Treatment of Hereditary Angi

Brief 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

Detailed Summary:

This was a Phase III, randomised, double blind, double dummy, multicentre, controlled,parallel group study of a 30 mg s.c. formulation of icatibant for the treatment of patients with moderate to very severe symptoms of cutaneous and/or abdominal symptoms of HAE.

The study consisted of two parts: controlled phase and OLE phase. For the primary endpoint, Efficacy was determined by evaluating the differences in study outcomes using a Visual Analogue Scale for patients treated with icatibant and tranexamic acid.


Sponsor: Shire

Current Primary Outcome: Time to Onset of Symptom Relief. [ Time Frame: 2 days ]

The primary efficacy endpoint was Time to onset of symptom relief (TOSR) following treatment with either icatibant or tranexamic acid. The median time to onset of symptom relief for the icatibant group was compared to the the median time to onset of symptom relief for the tranexamic acid group.

TOSR was defined as the time between time of injection to time of first documented onset of symptom relief for the three primary symptoms: cutaneous swelling, cutaneous skin, and abdominal pain.

The primary symptom was based on the type of attack. For abdominal attacks, the single primary symptom was abdominal pain. For cutaneous attacks, the single primary symptom was either skin swelling or skin pain, whichever was most severe.



Original Primary Outcome: Symptom relief (patient)

Current Secondary Outcome: Time to Almost Complete Symptom Relief [ Time Frame: 48 hours ]

Almost complete symptom relief was defined as a score between 0 and 10 mm on the VAS for at least three consecutive measurements for all symptoms.


Original Secondary Outcome: Safety and tolerability Additional efficacy assessments Pharmacoeconomics

Information By: Shire

Dates:
Date Received: July 12, 2007
Date Started: March 2005
Date Completion:
Last Updated: January 29, 2015
Last Verified: May 2014