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

Hereditary Angioedema (HAE) Clinical Trial

Official title:

EDEMA2: An Open-Label Study to Assess the Efficacy and Tolerability of Repeated Doses of DX-88 (Recombinant Plasma Kallikrein Inhibitor) in Patients With Hereditary Angioedema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01826916
• Other study ID #: DX-88/5
• Secondary ID: EDEMA2
• Status: Completed
• Phase: Phase 2
• Start date: November 1, 2003
• Est. completion date: January 1, 2006

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: January 1, 2006
• Est. primary completion date: December 1, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angioedema
• Hereditary Angioedema (HAE)

Intervention

Drug:
• DX-88 (ecallantide)
solution for injection 10 mg/mL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of attacks treated with successful outcome	successful outcome is defined as attack resolution begun within 4 hrs after treatment and maintained for 24 hours	24 hours
Primary	Proportion of attacks with a partial response	partial response is defined as an initial response to dosing followed by a relapse within 4 to 24 hours	24 hours
Secondary	Proportion of patients who respond to a 2nd dose of ecallantide after an initial, partial response		24 hours
Secondary	Time to resolution onset of each acute attack, as determined by patient report		24 hours