Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema

Browse trials for

• Angioedema 164
• Angioedemas, Hereditary 171

Keywords

• Hereditary Angioedema
• C1 inhibitor deficiency
• HAE
• Icatibant
• Bradykinin antagonist
• acute attack
• subcutaneous

Angioedema

164 studies on the registry are indexed under Angioedema; 19 are open to participants now.

This study's enrollment of 84 is above the median of 44 across 111 interventional studies indexed under Angioedema.

Lead sponsor

Shire is the lead sponsor of 346 studies on the registry; 2 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 47 (100%) have results posted.

Study arms

• Experimental
  Icatibant- Randomized

  Patients who were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.

  Drug: Icatibant

• Placebo comparator
  Placebo-Randomized

  Patients who were randomized to placebo in the controlled phase after they had an eligible first in-study attack.

  Drug: Placebo

• Experimental
  Controlled Open-label / laryngeal attack

  Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.

  Drug: Icatibant

• Experimental
  Untreated Patients at the baseline

  Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing (they were not treated during the Controlled phase but treated with icatibant during the Open Label Extension Phase (OLE) )

  Drug: Icatibant

Interventions

• DrugIcatibant

  30 mg (3mL) subcutaneous icatibant injection in the abdominal region

  Also known as: Brand name, Firazyr®

• DrugPlacebo

  Solution for injection, matched to study drug Single dose: 3 mL

Primary outcomes

1. Time to Onset of Symptom Relief (TOSR)

   The primary efficacy endpoint was TOSR assessed by the patient using a Visual Analogue Scale (VAS). The VAS is a scale used to measure intensity of each symptom of the attack at baseline and at the pre-determined time points throughout treatment period. It consists of a horizontal 10cm line, with the 0 point corresponding to a state where patient experiences no symptoms at all and the 10cm point represents the worst symptoms ever experienced by patient. The patient indicates his/her current state of symptoms by drawing a mark across the horizontal line. TOSR was defined as the time between time of injection to time of first documented onset of symptom relief for the 3 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.

   Time frame: 5 days

Secondary outcomes

1. Time to Regression (Start of Improvement) According to Patient

   This parameter assessed the time to regression (start of improvement) of observable(visible) symptoms according to the patients. Patients were asked "Report date and time when you feel that your symptoms start to improve".

   Time frame: 5 days

2. Time to Almost Complete Symptom Relief

   The time to almost complete symptom relief was defined as a score between 0 and 10 mm on the VAS for at least 3 consecutive measurements for all symptom.

   Time frame: 5 days

Baseline characteristics

Publications

• Malbran A, Riedl M, Ritchie B, Smith WB, Yang W, Banerji A, Hebert J, Gleich GJ, Hurewitz D, Jacobson KW, Bernstein JA, Khan DA, Kirkpatrick CH, Resnick D, Li H, Fernandez Romero DS, Lumry W. Repeat treatment of acute hereditary angioedema attacks with open-label icatibant in the FAST-1 trial. Clin Exp Immunol. 2014 Aug;177(2):544-53. doi: 10.1111/cei.12358. PubMed 24749847 ↗
• Cicardi M, Banerji A, Bracho F, Malbran A, Rosenkranz B, Riedl M, Bork K, Lumry W, Aberer W, Bier H, Bas M, Greve J, Hoffmann TK, Farkas H, Reshef A, Ritchie B, Yang W, Grabbe J, Kivity S, Kreuz W, Levy RJ, Luger T, Obtulowicz K, Schmid-Grendelmeier P, Bull C, Sitkauskiene B, Smith WB, Toubi E, Werner S, Anne S, Bjorkander J, Bouillet L, Cillari E, Hurewitz D, Jacobson KW, Katelaris CH, Maurer M, Merk H, Bernstein JA, Feighery C, Floccard B, Gleich G, Hebert J, Kaatz M, Keith P, Kirkpatrick CH, Langton D, Martin L, Pichler C, Resnick D, Wombolt D, Fernandez Romero DS, Zanichelli A, Arcoleo F, Knolle J, Kravec I, Dong L, Zimmermann J, Rosen K, Fan WT. Icatibant, a new bradykinin-receptor antagonist, in hereditary angioedema. N Engl J Med. 2010 Aug 5;363(6):532-41. doi: 10.1056/NEJMoa0906393. Erratum In: N Engl J Med. 2010 Oct 7;363(15):1486. PubMed 20818888 ↗