Evaluation of the Safety of Self-administration with Icatibant (EASSI)

• Research type

  Research Study

• Full title

  Open-label, Multicenter Study to Evaluate Safety, Local Tolerability, Convenience, and Efficacy of a Self-Administered Subcutaneous Formulation of Icatibant for the Treatment of Acute Attacks of Hereditary Angioedema

• IRAS ID

  30626

• Sponsor organisation

  Jerini AG

• Eudract number

  2008-000071-25

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Therapies for Hereditary Angioedema HAE are currently limited. In most European countries the following treatments for acute attacks are available: 1) replacement therapy with human plasma for severe attacks, 2) fibrinolysis inhibitors, 3) therapies aimed at symptom relief, 4) close monitoring of laryngeal attacks with possible intubation and surgical intervention, and 5) therapy with steroid hormones is primarily used for prophylaxis but is associated with significant side effects. In some European countries treatment of acute attacks with C1-INH is available. Besides availability, acceptance of these medicinal products is limited. As a new therapeutic option, icatibant (Firazyr©) was approved for marketing throughout Europe in July 2008 for the treatment of acute HAE attacks in adults (with C1-esterase inhibitor deficiency). In HAE, the level of bradykinin is increased in the bloodstream, which leads to clinical symptoms like swelling, pain, nausea and diarrhoea. Icatibant is a small molecule that is very specific and effective in blocking the activity of bradykinin and therefore stops further progression of the symptoms of an HAE attack. The goal of this clinical study is to develop icatibant for self-administration by patients at the first sign of swelling and so prevent progress of the acute edema attacks. This would be a desirable treatment option. The safety, local tolerability, patient satisfaction, and effectiveness of self-treatment of HAE episodes with subcutaneous (under the skin) injections of icatibant will be assessed in at least 25 patients. To achieve this approximately 150 patients will be enrolled.

• REC name

  London - South East Research Ethics Committee

• REC reference

  09/H1102/99

• Date of REC Opinion

  22 Oct 2009

• REC opinion

  Favourable Opinion