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

May 14, 2021 updated by: Shire

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5mg/m2 DX-88 IV
5mg/m2 DX-88 (ecallantide)administered intravenously
Drug: DX-88 (ecallantide)
solution for injection 10 mg/mL
Experimental: 10mg/m2 DX-88 IV
10mg/m2 DX-88(ecallantide)administered intravenously
Drug: DX-88 (ecallantide)
solution for injection 10 mg/mL
Experimental: 20mg/m2 DX-88 IV
20mg/m2 DX-88 (ecallantide) administered intravenously
Drug: DX-88 (ecallantide)
solution for injection 10 mg/mL
Experimental: 30 mg DX-88 SC
30mg DX-88(ecallantide)administered subcutaneously
Drug: DX-88 (ecallantide)
solution for injection 10 mg/mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of attacks treated with successful outcome
Time Frame: 24 hours
successful outcome is defined as attack resolution begun within 4 hrs after treatment and maintained for 24 hours
24 hours
Proportion of attacks with a partial response
Time Frame: 24 hours
partial response is defined as an initial response to dosing followed by a relapse within 4 to 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients who respond to a 2nd dose of ecallantide after an initial, partial response
Time Frame: 24 hours
24 hours
Time to resolution onset of each acute attack, as determined by patient report
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2003

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

April 4, 2013

First Posted (Estimate)

April 9, 2013

Study Record Updates

Last Update Posted (Actual)

May 18, 2021

Last Update Submitted That Met QC Criteria

May 14, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DX-88/5
  • EDEMA2 (Other Identifier: Dyax)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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