EDEMA2: Evaluation of DX-88's Effect in Mitigating Angioedema

Shire

Status and phase: Completed; Phase 2

Conditions: Hereditary Angioedema (HAE)

Treatments: Drug: DX-88 (ecallantide)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01826916

EDEMA2 (Other Identifier)

DX-88/5

Details and patient eligibility

About

EDEMA2 is an open-label, Phase 2 dose-ranging study designed to assess the safety and efficacy of repeated dosing of DX-88 (recombinant plasma kallikrein inhibitor) in Patients with Hereditary Angioedema.

Enrollment: 77 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 10 years of age or older
• Documented diagnosis of HAE (Type I or II)
• Patient reported to a study site no later than 4 hours following patient recognition of the onset of the attack
• Willing and able to give informed consent

Exclusion criteria

• Patients with a serious intercurrent illness or serious active infection
• Patient with serum creatinine greater than 110% the upper limit of normal or liver transaminases 2 times the upper limit of normal
• Receipt of an investigational drug or device, within 30 days prior to study treatment
• Pregnancy or breastfeeding
• Diagnosis of acquired angioedema (AAE)
• Patients who had not completed their Day-7 follow-up procedures for a previously treated attack

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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77 participants in 4 patient groups

5mg/m2 DX-88 IV

Experimental group

Description:

5mg/m2 DX-88 (ecallantide)administered intravenously

Treatment:

Drug: DX-88 (ecallantide)

10mg/m2 DX-88 IV

Experimental group

Description:

10mg/m2 DX-88(ecallantide)administered intravenously

Treatment:

Drug: DX-88 (ecallantide)

20mg/m2 DX-88 IV

Experimental group

Description:

20mg/m2 DX-88 (ecallantide) administered intravenously

Treatment:

Drug: DX-88 (ecallantide)

30 mg DX-88 SC

Experimental group

Description:

30mg DX-88(ecallantide)administered subcutaneously

Treatment:

Drug: DX-88 (ecallantide)