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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014