NCT01826916

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2012

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

April 9, 2013

Completed
Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

2.1 years

First QC Date

February 16, 2012

Last Update Submit

May 14, 2021

Conditions

Hereditary Angioedema (HAE)

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Proportion of patients who respond to a 2nd dose of ecallantide after an initial, partial response

    24 hours

  • Time to resolution onset of each acute attack, as determined by patient report

    24 hours

Study Arms (4)

5mg/m2 DX-88 IV

EXPERIMENTAL

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

Drug: DX-88 (ecallantide)

10mg/m2 DX-88 IV

EXPERIMENTAL

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

Drug: DX-88 (ecallantide)

20mg/m2 DX-88 IV

EXPERIMENTAL

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

Drug: DX-88 (ecallantide)

30 mg DX-88 SC

EXPERIMENTAL

30mg DX-88(ecallantide)administered subcutaneously

Drug: DX-88 (ecallantide)

Interventions

DX-88 (ecallantide)DRUG

solution for injection 10 mg/mL

10mg/m2 DX-88 IV20mg/m2 DX-88 IV30 mg DX-88 SC5mg/m2 DX-88 IV

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Rubinstein E, Stolz LE, Sheffer AL, Stevens C, Bousvaros A. Abdominal attacks and treatment in hereditary angioedema with C1-inhibitor deficiency. BMC Gastroenterol. 2014 Apr 9;14:71. doi: 10.1186/1471-230X-14-71.

    PMID: 24712435DERIVED

  • MacGinnitie AJ, Davis-Lorton M, Stolz LE, Tachdjian R. Use of ecallantide in pediatric hereditary angioedema. Pediatrics. 2013 Aug;132(2):e490-7. doi: 10.1542/peds.2013-0646. Epub 2013 Jul 22.

    PMID: 23878046DERIVED

MeSH Terms

Conditions

Angioedemas, Hereditary

Interventions

ecallantide

Condition Hierarchy (Ancestors)

AngioedemaVascular DiseasesCardiovascular DiseasesHereditary Complement Deficiency DiseasesPrimary Immunodeficiency DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesUrticariaSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesImmunologic Deficiency Syndromes

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2012

First Posted

April 9, 2013

Study Start

November 1, 2003

Primary Completion

December 1, 2005

Study Completion

January 1, 2006

Last Updated

May 18, 2021

Record last verified: 2021-05