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

This study has been terminated.
(Interim analysis suggested a trend favoring ecallantide; observed response rate to placebo was substantially higher than described in medical literature.)
Sponsor:
Information provided by (Responsible Party):
Dyax Corp.
ClinicalTrials.gov Identifier:
NCT01343823
First received: April 27, 2011
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

A double-blind, randomized, controlled trial comparing the safety and effectiveness of conventional therapy with ecallantide to conventional therapy with placebo.


Condition Intervention Phase
ACE Inhibitor Induced Angioedema
Drug: ecallantide 60 mg
Drug: ecallantide 30 mg
Drug: ecallantide 10 mg
Drug: placebo
Drug: placebo match for 30 mg ecallantide arm
Drug: placebo match for 10 mg ecallantide arm
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema

Resource links provided by NLM:


Further study details as provided by Dyax Corp.:

Primary Outcome Measures:
  • Safety and Efficacy of Ecallantide [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Time to Symptom Resolution Based on the Visual Analog Scale (VAS) [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]

    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".



Enrollment: 76
Study Start Date: June 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Administered as one 3 mL SC injection containing 10 mg ecallantide.
Drug: placebo match for 10 mg ecallantide arm
One 3 mL SC injection of matching placebo given to subjects randomized to the 10 mg ecallantide arm.
Placebo Comparator: placebo
Administered as two SC 3 mL injections
Drug: placebo
Administered as two SC 3 mL injections
Active Comparator: ecallantide 60mg
Administered as two 3 mL SC injections, each containing 30 mg ecallantide
Drug: ecallantide 60 mg
Administered as two 3 mL SC injections, each containing 30 mg ecallantide
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
Administered as one 3 mL SC injection containing 30 mg ecallantide
Drug: placebo match for 30 mg ecallantide arm
One 3 mL SC injection of matching placebo given to subjects randomized to the 30 mg ecallantide arm.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females 18 years of age or older
  • Must currently be on ACE inhibitor therapy and have received a dose within 36 hours
  • Presenting with ACEIA of the head/neck region within 12 hours after onset
  • All females must have a negative urine pregnancy test prior to administration of the study drug. Those who have had a total hysterectomy, bilateral oophorectomy or are two years post-menopausal do not require a pregnancy test.

Exclusion Criteria:

  • Hypersensitivity to ecallantide
  • Pregnancy or breast feeding
  • Patients who have had angioedema and were not concurrently on an ACE inhibitor
  • Patients exhibiting urticaria
  • Patients who are intubated or who have a tracheostomy related to the current episode of angioedema
  • Opinion of the investigator that the patient would not be a good candidate
  • Participation in another investigational study within 30 days prior to enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343823

  Show 39 Study Locations
Sponsors and Collaborators
Dyax Corp.
  More Information

No publications provided

Responsible Party: Dyax Corp.
ClinicalTrials.gov Identifier: NCT01343823     History of Changes
Other Study ID Numbers: DX-88/27
Study First Received: April 27, 2011
Results First Received: September 4, 2013
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Angioedema
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014