Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema

Browse trials for

• Angioedema 164

Angioedema

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

This study's enrollment of 79 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

• Active comparator
  ecallantide 10mg

  Administered as one 3 mL SC injection containing 10 mg ecallantide and one 3 mL SC injection of matching placebo.

  Drug: ecallantide 10 mg · Drug: placebo match for 10 mg ecallantide arm

• Placebo comparator
  placebo

  Administered as two SC 3 mL injections

  Drug: placebo

• Active comparator
  ecallantide 60mg

  Administered as two 3 mL SC injections, each containing 30 mg ecallantide

  Drug: ecallantide 60 mg

• Active comparator
  ecallantide 30mg

  Administered as one 3 mL SC injection containing 30 mg ecallantide and one 3 mL SC injection of matching placebo.

  Drug: ecallantide 30 mg · Drug: placebo match for 30 mg ecallantide arm

Interventions

• Drugecallantide 60 mg

  Administered as two 3 mL SC injections, each containing 30 mg ecallantide

• Drugecallantide 30 mg

  Administered as one 3 mL SC injection containing 30 mg ecallantide

• Drugecallantide 10 mg

  Administered as one 3 mL SC injection containing 10 mg ecallantide.

• Drugplacebo

  Administered as two SC 3 mL injections

• Drugplacebo match for 30 mg ecallantide arm

  One 3 mL SC injection of matching placebo given to subjects randomized to the 30 mg ecallantide arm.

• Drugplacebo match for 10 mg ecallantide arm

  One 3 mL SC injection of matching placebo given to subjects randomized to the 10 mg ecallantide arm.

Primary outcomes

1. Safety and Efficacy of Ecallantide

   Compare the proportion of patients meeting prespecified discharge criteria in the group receiving ecallantide with conventional therapy to patients receiving placebo with conventional therapy. Patients were evaluated against 6 discharge eligibility criteria at 1,2,3,4,5, and 6 hours after study drug administration or until discharged from the ER. A responder was defined as a patient meeting all six discharge eligibility criteria as below: • Improvement of edema to "a little better" or "a lot better" as assessed by health care provider using a five point scale • Stable vital signs (within an acceptable range) • Absence of stridor • Absence of dyspnea or use of accessory muscles during respiration • Absence of drooling • Able to drink without difficulty

   Time frame: 6 hours

Secondary outcomes

1. Time to Symptom Resolution Based on the Visual Analog Scale (VAS)

   Compare the time to onset of symptom resolution between the ecallantide-treated and placebo-treated groups. The patient assessed severity of the angioedema attack using a VAS at baseline and following study drug administration every 15 minutes for the first 2 hours and then every 30 minutes through 6 hours post dosing or until the time of discharge from the ER (whichever occurred first). The scale ranged from "totally resolved" to "very severe".

   Time frame: 6 hours

Baseline characteristics

Publications

• Lewis LM, Graffeo C, Crosley P, Klausner HA, Clark CL, Frank A, Miner J, Iarrobino R, Chyung Y. Ecallantide for the acute treatment of angiotensin-converting enzyme inhibitor-induced angioedema: a multicenter, randomized, controlled trial. Ann Emerg Med. 2015 Feb;65(2):204-13. doi: 10.1016/j.annemergmed.2014.07.014. Epub 2014 Aug 30. PubMed 25182544 ↗