Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE)

Hereditary Angioedema (HAE) Clinical Trial

Official title:

Open-label Patient Continuation of DX-88 (Ecallantide) for Acute Hereditary Angioedema Attacks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00456508
• Other study ID #: DX-88/19
• Status: Completed
• Phase: Phase 3
• Start date: April 1, 2007
• Est. completion date: September 1, 2010

Study information

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

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of repeated doses of ecallantide in the treatment of acute attacks of hereditary angioedema and to allow HAE patients continued access to ecallantide. In addition, patients enrolled in DX-88/20 (EDEMA4) trial will be followed up and treated for subsequent attacks in this trial.

Description:

This is an open label trial.

The study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide in the treatment of acute attacks of hereditary angioedema. This study is designed to provide efficacy and safety data on repeated use of ecallantide. These data are intended to support the marketing authorization of ecallantide in the treatment of acute attacks of hereditary angioedema. Efficacy and safety of ecallantide will be evaluated in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: September 1, 2010
• Est. primary completion date: June 1, 2010
• 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)

• Willing and able to give informed consent

• Acute HAE attack at time of presentation

Exclusion Criteria:

• Receipt of an investigational drug or device, within 30 days prior to study treatment, other than DX-88 (ecallantide)

• Pregnancy or breastfeeding

• Receipt of non-investigational C1-INH or DX-88 within 72 hours of treatment

• Patients eligible for current, ongoing clinical trial in which DX 88 (ecallantide) is offered

Related Conditions & MeSH terms

• Angioedema
• Hereditary Angioedema (HAE)

Intervention

Drug:
• ecallantide
solution for SC injection, one 30 mg dose per HAE attack

Locations

Country	Name	City	State
Canada	Allergy and Asthma Research Centre	Ottawa	Ontario
Jordan	Jordan University Hospital	Amman
United States	Allergy Partners of Albuquerque	Albuquerque	New Mexico
United States	Allergy Partners of Western North Carolina	Asheville	North Carolina
United States	Family Allergy & Asthma Center, PC	Atlanta	Georgia
United States	Alta Bates Summit Comprehensive Cancer Center	Berkeley	California
United States	Highlands Allergy and Asthma Center, PC	Bristol	Tennessee
United States	The Paull Allergy and Asthma Clinic, P.A	Bryan	Texas
United States	Brigham and Women's Hospital	Chestnut Hill	Massachusetts
United States	University Consultants in Allergy and Immunology	Chicago	Illinois
United States	University of Cincinnati, Division of Internal Medicine	Cincinnati	Ohio
United States	Asthma and Allergy Institutes of Michigan	Clinton Township	Michigan
United States	Asthma and Allergy Associates, P.C.	Colorado Springs	Colorado
United States	Allergy Center of Brookstone	Columbus	Georgia
United States	Optimed Research, LLC	Columbus	Ohio
United States	Pacific Coast Allergy	Crescent City	California
United States	AARA Research Center	Dallas	Texas
United States	Jacob Offenberger	Granada Hills	California
United States	Penn State Milton S Hershey Medical Center	Hershey	Pennsylvania
United States	Nevada Access to Research and Education Society	Las Vegas	Nevada
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Little Rock Allergy & Asthma Clinic	Little Rock	Arkansas
United States	UCLA David Geffen School of Medicine, Department of Medicine	Los Angeles	California
United States	University of Miami, General Clinical Research Center	Miami	Florida
United States	Winthrop University Hospital	Mineola	New York
United States	Muncie Allergy Center	Muncie	Indiana
United States	Christiana Hospital, Christiana Care Health Services	Newark	Delaware
United States	UMDNJ- New Jersey Medical School	Newark	New Jersey
United States	Clinical Research Associates of Tidewater	Norfolk	Virginia
United States	Kansas City Allergy & Asthma	Overland Park	Kansas
United States	Asthma Allergy and Pulmonary Associates	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Nevada School of Medicine	Reno	Nevada
United States	University of Utah Health Sciences Center	Salt Lake City	Utah
United States	Aaron Davis	Scottsdale	Arizona
United States	Puget Sound Allergy, Asthma, & Immunology	Tacoma	Washington
United States	University of South Florida, Asthma, Allergy and Immunology Clinical Research Unit	Tampa	Florida
United States	Georgetown University Medical Center, Georgetown University Hospital	Washington	District of Columbia
United States	Roberson Allergy and Asthma	West Palm Beach	Florida
United States	Institute for Asthma and Allergy	Wheaton	Maryland
United States	Respiratory Medicine Research Institute of Michigan, PLC	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Countries where clinical trial is conducted

United States,  Canada,  Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing	Mean Symptom Complex Severity (MSCS) score is a validated point-in-time measure of symptom severity. At baseline and 4 hrs, patients rated the severity on a categorical scale (0=normal, 1=mild, 2=moderate, 3=severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement was indicated by a reduction in the score of 0.30 or more.	4 hrs post dose after every episode
Secondary	Treatment Outcome Score (TOS) at 4 Hrs Post Dosing, Based on the Patient Assessment of Baseline Severity of Symptoms	The Treatment Outcome Score (TOS)is a validated measure of response to therapy. Response assessment for each symptom complex (internal head/neck, stomach/GI, genital/buttocks, external head/neck or cutaneous) was to be weighted based on the severity of symptom complexes at baseline. Severity assessment at baseline was rated on a categorical scale (1=mild, 2=moderate, 3=severe) for symptoms at each affected symptom complex. Response assessment of each symptom complex post-dosing relative to baseline used a scale (100=significant improvement, 50=improvement, 0=same). The weighted values were used to calculate the composite TOS. A TOS greater than 0 denotes an improvement in symptoms compared with baseline severity.	4 hrs post dose after every episode
Secondary	Time to Significant Improvement	Time to significant improvement in overall response based on the period from 15 minutes after dosing through 4 hrs post dosing. Significant improvement was defined as a response of "a lot better or resolved" in the overall response assessment.	15 min - 4 hrs post dose after every episode