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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: June 26, 2012
Last verified: June 2012
History of Changes
  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
Drug: placebo
 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:

Drug Information available for: Ecallantide
U.S. FDA Resources

Further study details as provided by Dyax Corp.:

Primary Outcome Measures:
  • safety and efficacy of ecallantide [ Time Frame: 1 week ] [ 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. Evaluate safety for the ecallantide-treated and placebo-treated patients.


Secondary Outcome Measures:
  • assess the efficacy of ecallantide [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    Compare the time to onset of symptom resolution between the ecallantide-treated and placebo-treated groups. Compare the proportion of patients in the ecallantide-treated and placebo-treated groups meeting primary endpoint criteria without return of symptoms at 24 hours post dose.

  • compare need for intervention or hospitalization [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    Compare the ecallantide-treated and placebo-treated groups for the need for intervention to support airway; for the use of additional medication as rescue therapy; for rates of admission to ICU or step down unit


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
10 - 60 mg administered as SC injections of ecallantide
 Drug: ecallantide
60 mg administered as two 30 mg SC injections of ecallantide
Drug: ecallantide
30 mg administered as one 30 mg SC injection of ecallantide and one matching placebo
Drug: ecallantide
10 mg administered as one 10 mg SC injection of ecallantide and one matching placebo
Placebo Comparator: placebo
phosphate buffered saline administered as SC injections
 Drug: placebo
saline administered as two SC injections

  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
Last Updated: June 26, 2012
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 June 17, 2013