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

B

Bernstein, Jonathan A., M.D.

Status and phase

Unknown
Phase 2

Conditions

Angioedema

Treatments

Drug: ecallantide - Kallikrein inhibitor that blocks the production of bradykinin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01036659
ACE Induced Angioedema

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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
  • Must currently be on an ACE inhibitor
  • Presenting with ACE induced angioedema within 12 hours after onset. This is to be documented in the source document and CRF
  • All females of childbearing age must have a negative pregnancy test prior to administration of the study drug.

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

50 participants in 3 patient groups, including a placebo group

Ecallantide in conjunction with Conventional Therapy
Active Comparator group
Treatment:
Drug: ecallantide - Kallikrein inhibitor that blocks the production of bradykinin
Conventional therapy and placebo
Placebo Comparator group
Treatment:
Drug: ecallantide - Kallikrein inhibitor that blocks the production of bradykinin
Historical Evaluation
No Intervention group

Trial contacts and locations

3

Loading...

Central trial contact

Sarah J. Holmes, RN; Jillian Picard, RN

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems