Recruiting
Phase 2

Ecallantide

Sponsor:

Bernstein, Jonathan A., M.D.

Code:

NCT01036659

Conditions

Angioedema

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

ecallantide - Kallikrein inhibitor that blocks the production of bradykinin

Study Details

Brief summary:

The investigators will conduct a double-blind, randomized controlled trial comparing the safety and effectiveness of ecallantide to conventional therapy. A rescue cross-over design will be used such that patients failing to improve on standard therapy will additionally be treated with ecallantide. Therefore, a historical control cohort will be enrolled for analysis of secondary endpoints. In addition, since some patients treated with conventional therapy may improve rapidly and therefore not be eligible for inclusion in the study, the investigators will enroll these patients as an observational arm to enable the conduct of sensitivity analysis.

Conditions

Angioedema

Study ID

NCT01036659

Start date

May, 2010

Status verified date

Mar, 2012

Completion date

Dec, 2013

Anticipated

Primary completion date

Jun, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Males and females of any race or ethnicity 18 or older. The locations of the study will permit all racial and ethnic distribution in the study
2. Must currently be on an ACE inhibitor
3. Presenting with ACE induced angioedema within 12 hours after onset. This is to be documented in the source document and CRF
4. All females of childbearing age must have a negative pregnancy test prior to administration of the study drug.

Exclusion Criteria:

1. Participation in another investigational study within 30 days prior to enrollment
2. Patients who improve on conventional (standard of care) therapy
3. Patients previously treated with ecallantide
4. Hypersensitivity to ecallantide
5. Pregnancy or breast feeding
6. Other definable causes of angioedema (i.e., hereditary or acquired angioedema)
7. Patients receiving C-1 inhibitor as prophylaxis
8. Treatment requiring tranexamic acid, and epsilon-aminocaproic acid
9. Receiving fresh frozen plasma within 3 days prior to enrollment

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Ecallantide in conjunction with Conventional Therapy

placebo comparator: Conventional therapy and placebo

no intervention: Historical Evaluation

Interventions

ecallantide - Kallikrein inhibitor that blocks the production of bradykinin

subcutaneous dose of 30mg of ecallantide or placebo (three 10 mg SC injections at three different sites ((arms, legs, abdomen). Injections are not to be administered at the attack location.

Primary outcome measure

  • Objective criteria that allow for discharge directly from the ED at or before 4 hours:(stable vital signs, no evidence of stridor, dysphagia or drooling, edema has regressed to or did not progress beyond Class I. [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Jillian Picard, RN

513-558-0924jillian.picard@uc.edu

Sarah J. Holmes, RN

513-558-0924sarah.holmes@uc.edu

Locations

The Jewish Hospital

Recruiting

Cincinnati, Ohio, United States, 45201

Contacts

Jillian K Picard, RN, BSN

513-558-0924Jillian.picard@uc.edu

Sarah J Holmes, RN, BSN

513-558-0924Sarah.holmes@uc.edu

Principal Investigator:

Joseph Moellman, MD

Univeristy Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Jillian K Picard, RN, BSN

513-558-0924Jillian.picard@uc.edu

Sarah J Holmes, RN, BSN

513-558-0924Sarah.holmes@uc.edu

Principal Investigator:

Jonathan A Bernstein, MD

UC Physicians, Dpt of Internal Medicine, Division of Immunology

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Jillian Picard, RN

513-558-0924jillian.picard@uc.edu

Sarah J. Holmes, RN

513-558-0924sarah.holmes@uc.edu

More Information

Sponsor

Bernstein, Jonathan A., M.D.

Last update posted

Mar 9, 2012

Last verified

Mar, 2012

Keywords

  • acute angiotensin converting enzyme inhibitor angioedema

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bernstein, Jonathan A., M.D. on 2012-03-09.