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

Primary Purpose

Hereditary Angioedema (HAE)

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

DX-88 (ecallantide)

About this trial

This is an interventional treatment trial for Hereditary Angioedema (HAE)

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

5mg/m2 DX-88 IV

10mg/m2 DX-88 IV

20mg/m2 DX-88 IV

30 mg DX-88 SC

Arm Description

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

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

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

30mg DX-88(ecallantide)administered subcutaneously

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT01826916

First Posted

February 16, 2012

Last Updated

May 14, 2021

Sponsor

Shire

1. Study Identification

Unique Protocol Identification Number

NCT01826916

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

November 1, 2003 (Actual)

Primary Completion Date

December 1, 2005 (Actual)

Study Completion Date

January 1, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shire

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hereditary Angioedema (HAE)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

77 (Actual)

8. Arms, Groups, and Interventions

Arm Title

5mg/m2 DX-88 IV

Arm Type

Experimental

Arm Description

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

Arm Title

10mg/m2 DX-88 IV

Arm Type

Experimental

Arm Description

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

Arm Title

20mg/m2 DX-88 IV

Arm Type

Experimental

Arm Description

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

Arm Title

30 mg DX-88 SC

Arm Type

Experimental

Arm Description

30mg DX-88(ecallantide)administered subcutaneously

Intervention Type

Drug

Intervention Name(s)

DX-88 (ecallantide)

Intervention Description

solution for injection 10 mg/mL

Primary Outcome Measure Information:

Title

Proportion of attacks treated with successful outcome

Description

successful outcome is defined as attack resolution begun within 4 hrs after treatment and maintained for 24 hours

Time Frame

24 hours

Title

Proportion of attacks with a partial response

Description

partial response is defined as an initial response to dosing followed by a relapse within 4 to 24 hours

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

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

Time Frame

24 hours

Title

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

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Director

Organizational Affiliation

Takeda

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

24712435

Citation

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.

Results Reference

derived

PubMed Identifier

23878046

Citation

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.

Results Reference

derived

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

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