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

Shire

Status and phase: Terminated; Phase 2

Conditions: ACE Inhibitor Induced Angioedema

Treatments: Drug: placebo match for 30 mg ecallantide arm; Drug: ecallantide 60 mg; Drug: placebo; Drug: ecallantide 10 mg; Drug: placebo match for 10 mg ecallantide arm; Drug: ecallantide 30 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01343823

DX-88/27

Details and patient eligibility

About

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

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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79 participants in 4 patient groups, including a placebo group

ecallantide 10mg

Active Comparator group

Description:

Administered as one 3 mL SC injection containing 10 mg ecallantide and one 3 mL SC injection of matching placebo.

Treatment:

Drug: ecallantide 10 mg

Drug: placebo match for 10 mg ecallantide arm

placebo

Placebo Comparator group

Description:

Administered as two SC 3 mL injections

Treatment:

Drug: placebo

ecallantide 60mg

Active Comparator group

Description:

Administered as two 3 mL SC injections, each containing 30 mg ecallantide

Treatment:

Drug: ecallantide 60 mg

ecallantide 30mg

Active Comparator group

Description:

Administered as one 3 mL SC injection containing 30 mg ecallantide and one 3 mL SC injection of matching placebo.

Treatment:

Drug: placebo match for 30 mg ecallantide arm

Drug: ecallantide 30 mg