Idiopathic Angioedema
Conditions
Interventions
Trade Name: Firazyr
Product Name: Firazyr
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Icatibant acetate
Concentration unit: mg/g milligram(s)/gram
Concentrat
Sponsors
Barts and the London NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female; • Age = than 18 years; • C1-inhibitor functional levels = 50% of normal values • Current oedema attack must be in the cutaneous or mucosal areas; • Current oedema attack must be moderate to severe; • Women of childbearing potential must have a negative urine pregnancy test; • Signed written Informed Consent given Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Diagnosis of angioedema of any defined cause, for example, allergic, hereditary/acquired C1-Inhibitor deficiency, ACE inhibitor induced angioedema, drug and/or food induced angioedema; • Urticaria-associated angioedema • Participation in a clinical trial of another Investigational Product (IP) within the past month; • Treatment with any other medication likely to influence the outcome since onset of the current oedema attack; • On treatment with ACE inhibitors; • Evidence of severe coronary artery disease based on medical history or screening examination; • Pregnancy and/or breast-feeding; • Mental or physical condition rendering the subject, in the opinion of the investigator, unable to understand the nature, scope and possible consequences of the study; • Unlikely to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: These will be: Time to first onset of relief; Response rate at 4 hours after start of treatment; Visual Analogue Scale (VAS) at 2, 4, 6, 8, 10, 12, 14, 18, 24, 36 and 48 hours post attack Time to almost complete symptom relief; Need for rescue therapy within 24 hours; Adverse events;Primary end point(s): The primary efficacy endpoint is the time to onset of symptom relief. The severity of the symptoms will be measured using a Visual Analogue Scale (VAS) of 100 mm length. The first absolute reduction by 20% of pre-treatment value, confirmed at three consecutive measurements after treatment, is defined as the onset of symptom relief. The difference in time to onset of symptom relief is tested using the VAS with highest score at baseline, if baseline values are identical hierarchical value will be as follow: dyspnea>dysphagia>swelling;Timepoint(s) of evaluation of this end point: The primary efficacy endpoint is the time to onset of symptom relief.;Main Objective: To assess the efficacy of the bradykinin (BK) B2 antagonist, Icatibant, in the relief of symptoms resulting from moderate to severe angioedema of the face, neck, arms, genitals, tongue, pharynx and larynx, where the diagnosis is of Idiopathic Angioedema - unresponsive to antihistamines. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to first onset of relief; Response rate at 4 hours after start of treatment; VAS at 4 hours; Time to almost complete symptom relief; Need for rescue therapy within 24 hours; Adverse events.;Timepoint(s) of evaluation of this end point: The primary efficacy endpoint is the time to onset of symptom relief. | — |
Countries
United Kingdom
Contacts
Public ContactChief Investigator
Dr Hilary Longhurst
Outcome results
None listed