C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study)

April 20, 2015 updated by: CSL Behring

Open-label Extension Study of CE1145 (Human Pasteurized C1 Esterase Inhibitor Concentrate) in Subjects With Congenital C1-INH Deficiency and Acute HAE Attacks

Hereditary angioedema (HAE) is a rare disorder characterized by congenital lack of functional C1 esterase inhibitor. If not treated adequately, the acute attacks of HAE can be life-threatening and may even result in fatalities, especially in case of involvement of the larynx.The planned extension study is designed to enrol subjects that participated in the pivotal study in order to provide them with C1-INH for treatment of acute HAE attacks for 24 months or until the licensing procedure for C1-INH is finalized, whatever comes first.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, KIY 4G2
        • Contact CSL Behring for facility details
  • United States
    • Florida
      • Weston, Florida, United States, 33331
        • Contact CSL Behring for facility details
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Contact CSL Behring for facility details
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Contact CSL Behring for facility details
    • Illinois
      • Chicago, Illinois, United States, 60612-3244
        • Contact CSL Behring for facility details
    • Louisiana
      • Shreveport, Louisiana, United States, 71130
        • Contact CSL Behring for facility details
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Contact CSL Behring for facility details
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Contact CSL Behring for facility details
    • Nebraska
      • Omaha, Nebraska, United States, 69131
        • Contact CSL Behring for facility details
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Contact CSL Behring for facility details
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Contact CSL Behring for facility details
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Contact CSL Behring for facility details
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Contact CSL Behring for facility details
    • Texas
      • Dallas, Texas, United States, 75230
        • Contact CSL Behring for facility details

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 (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Documented congenital C1-INH deficiency
  • Acute HAE attack
  • Participation in base study CE1145_3001 (NCT00168103)

Key Exclusion Criteria:

  • Acquired angioedema
  • Treatment with any other investigational drug besides CE1145 in the last 30 days before study entry

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: C1 Esterase Inhibitor
Drug: C1 Esterase Inhibitor
Lyophilisate containing approximately 500 U C1-INH to be reconstituted with 10 mL water for injection; Single Dose: 20 U/kg b.w. iv
Other Names:
  • Berinert P

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Start of Relief of Symptoms From HAE Attack (Intent to Treat (ITT) Subject Population)
Time Frame: Up to 24 h after start of study treatment
The start of symptom relief was determined by subject self-assessment.
Up to 24 h after start of study treatment
Time to Start of Relief of Symptoms From HAE Attack (ITT Attack Population)
Time Frame: Up to 24 h after start of study treatment
The start of symptom relief was determined by subject self-assessment.
Up to 24 h after start of study treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Complete Resolution of All HAE Symptoms (ITT Subject Population)
Time Frame: Up to Day 9 following an attack
Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card.
Up to Day 9 following an attack
Time to Complete Resolution of All HAE Symptoms (ITT Attack Population)
Time Frame: Up to Day 9 following an attack
Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card.
Up to Day 9 following an attack

Collaborators and Investigators

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

Sponsor

CSL Behring

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

Helpful Links

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

August 1, 2005

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

February 15, 2006

First Submitted That Met QC Criteria

February 15, 2006

First Posted (ESTIMATE)

February 16, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 7, 2015

Last Update Submitted That Met QC Criteria

April 20, 2015

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE1145_3003
  • 1453 (OTHER: CSL Behring)

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.

Clinical Trials on Hereditary Angioedema

Clinical Trials on C1 Esterase Inhibitor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe