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

Primary Purpose

Hereditary Angioedema

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
C1 Esterase Inhibitor
Sponsored by
CSL Behring
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hereditary Angioedema focused on measuring C1 Inhibitor, Hereditary angioedema, Acute HAE attack

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details
  • Contact CSL Behring for facility details

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

C1 Esterase Inhibitor

Arm Description

Outcomes

Primary Outcome Measures

Time to Start of Relief of Symptoms From HAE Attack (Intent to Treat (ITT) Subject Population)
The start of symptom relief was determined by subject self-assessment.
Time to Start of Relief of Symptoms From HAE Attack (ITT Attack Population)
The start of symptom relief was determined by subject self-assessment.

Secondary Outcome Measures

Time to Complete Resolution of All HAE Symptoms (ITT Subject Population)
Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card.
Time to Complete Resolution of All HAE Symptoms (ITT Attack Population)
Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card.

Full Information

First Posted
February 15, 2006
Last Updated
April 20, 2015
Sponsor
CSL Behring
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1. Study Identification

Unique Protocol Identification Number
NCT00292981
Brief Title
C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study)
Official Title
Open-label Extension Study of CE1145 (Human Pasteurized C1 Esterase Inhibitor Concentrate) in Subjects With Congenital C1-INH Deficiency and Acute HAE Attacks
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Behring

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Angioedema
Keywords
C1 Inhibitor, Hereditary angioedema, Acute HAE attack

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
C1 Esterase Inhibitor
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
C1 Esterase Inhibitor
Other Intervention Name(s)
Berinert P
Intervention Description
Lyophilisate containing approximately 500 U C1-INH to be reconstituted with 10 mL water for injection; Single Dose: 20 U/kg b.w. iv
Primary Outcome Measure Information:
Title
Time to Start of Relief of Symptoms From HAE Attack (Intent to Treat (ITT) Subject Population)
Description
The start of symptom relief was determined by subject self-assessment.
Time Frame
Up to 24 h after start of study treatment
Title
Time to Start of Relief of Symptoms From HAE Attack (ITT Attack Population)
Description
The start of symptom relief was determined by subject self-assessment.
Time Frame
Up to 24 h after start of study treatment
Secondary Outcome Measure Information:
Title
Time to Complete Resolution of All HAE Symptoms (ITT Subject Population)
Description
Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card.
Time Frame
Up to Day 9 following an attack
Title
Time to Complete Resolution of All HAE Symptoms (ITT Attack Population)
Description
Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card.
Time Frame
Up to Day 9 following an attack

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Program Director
Organizational Affiliation
CSL Behring
Official's Role
Study Director
Facility Information:
Facility Name
Contact CSL Behring for facility details
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Contact CSL Behring for facility details
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Contact CSL Behring for facility details
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Contact CSL Behring for facility details
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3244
Country
United States
Facility Name
Contact CSL Behring for facility details
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
Contact CSL Behring for facility details
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Contact CSL Behring for facility details
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Contact CSL Behring for facility details
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
69131
Country
United States
Facility Name
Contact CSL Behring for facility details
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
Contact CSL Behring for facility details
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Contact CSL Behring for facility details
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Contact CSL Behring for facility details
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Contact CSL Behring for facility details
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Contact CSL Behring for facility details
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
KIY 4G2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20635155
Citation
Craig TJ, Wasserman RL, Levy RJ, Bewtra AK, Schneider L, Packer F, Yang WH, Keinecke HO, Kiessling PC. Prospective study of rapid relief provided by C1 esterase inhibitor in emergency treatment of acute laryngeal attacks in hereditary angioedema. J Clin Immunol. 2010 Nov;30(6):823-9. doi: 10.1007/s10875-010-9442-1. Epub 2010 Jul 16.
Results Reference
background
PubMed Identifier
24661784
Citation
Bernstein JA, Machnig T, Keinecke HO, Whelan GJ, Craig TJ. The effect of weight on the efficacy and safety of C1 esterase inhibitor concentrate for the treatment of acute hereditary angioedema. Clin Ther. 2014 Apr 1;36(4):518-25. doi: 10.1016/j.clinthera.2014.02.005. Epub 2014 Mar 21. Erratum In: Clin Ther. 2014 Jun 1;36(6):992.
Results Reference
background
PubMed Identifier
25803207
Citation
Bork K, Craig TJ, Bernstein JA, Feuersenger H, Machnig T, Staubach P. Efficacy of C1 esterase inhibitor concentrate in treatment of cutaneous attacks of hereditary angioedema. Allergy Asthma Proc. 2015 May-Jun;36(3):218-24. doi: 10.2500/aap.2015.36.3844. Epub 2015 Mar 23.
Results Reference
background
PubMed Identifier
21195947
Citation
Wasserman RL, Levy RJ, Bewtra AK, Hurewitz D, Craig TJ, Kiessling PC, Keinecke HO, Bernstein JA. Prospective study of C1 esterase inhibitor in the treatment of successive acute abdominal and facial hereditary angioedema attacks. Ann Allergy Asthma Immunol. 2011 Jan;106(1):62-8. doi: 10.1016/j.anai.2010.10.012. Epub 2010 Nov 20.
Results Reference
result
PubMed Identifier
21884533
Citation
Craig TJ, Bewtra AK, Bahna SL, Hurewitz D, Schneider LC, Levy RJ, Moy JN, Offenberger J, Jacobson KW, Yang WH, Eidelman F, Janss G, Packer FR, Rojavin MA, Machnig T, Keinecke HO, Wasserman RL. C1 esterase inhibitor concentrate in 1085 Hereditary Angioedema attacks--final results of the I.M.P.A.C.T.2 study. Allergy. 2011 Dec;66(12):1604-11. doi: 10.1111/j.1398-9995.2011.02702.x. Epub 2011 Sep 2.
Results Reference
result
PubMed Identifier
23987198
Citation
Craig TJ, Rojavin MA, Machnig T, Keinecke HO, Bernstein JA. Effect of time to treatment on response to C1 esterase inhibitor concentrate for hereditary angioedema attacks. Ann Allergy Asthma Immunol. 2013 Sep;111(3):211-5. doi: 10.1016/j.anai.2013.06.021. Epub 2013 Jul 16.
Results Reference
derived
PubMed Identifier
22856636
Citation
Craig TJ, Bewtra AK, Hurewitz D, Levy R, Janss G, Jacobson KW, Packer F, Bernstein JA, Rojavin MA, Machnig T, Keinecke HO, Wasserman RL. Treatment response after repeated administration of C1 esterase inhibitor for successive acute hereditary angioedema attacks. Allergy Asthma Proc. 2012 Jul-Aug;33(4):354-61. doi: 10.2500/aap.2012.33.3589.
Results Reference
derived
Links:
URL
http://www.hereditaryangioedema.com
Description
United States Hereditary Angioedema Association
URL
http://www.cslbehring.com/clinical-trials/contact-us.htm?registryRefNum=NCT00292981&registryName=ctgov
Description
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C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study)

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