Clinical trial NCT01108848: Patient Registry Study of Berinert® in Normal Clinical Practice
Official title: Patient Registry for Berinert®, a C1-Esterase Inhibitor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Includes: Hereditary Angioedema
Keywords: C1-esterase Inhibitor
Hereditary angioedema
Acute HAE attack
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
Collaborators: name: Chiltern International Inc.
First posted: 2010-04-22
Enrollment: 318
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: An attempt will be made to prospectively identify patients and enroll them into this registry before treatment is required. In addition, retrospective chart/case review and data collection may be conducted.

Brief summary: The objective of this patient registry is to collect data on the safety of Berinert® in normal clinical practice in the United States. The patient registry will be maintained for a period of at least 3 years. The duration of individual patient participation will vary and is determined by the frequency of hereditary angioedema (HAE) attacks and the patient's need for Berinert® treatment.


Eligibility criteria: Inclusion Criteria:

* Any patient receiving CSL Behring's C1-esterase inhibitor
* Written informed consent (may not be required for some retrospective chart review cases)

Exclusion Criteria:

* Any patient participating in an HAE study using other C1-inhibitors than Berinert®

Primary outcomes:
measure: Incidence of thrombotic and thrombo-embolic events
timeFrame: Within 30 days of treatment with Berinert®
measure: Occurrence of suspected viral transmission
timeFrame: Duration of the study, at least 3 years
measure: Use of concomitant medications and plasma products
timeFrame: Duration of the study, at least 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: United States, Arizona
state: Arizona
city: Granada Hills
country: United States
facility: United States, California
state: California
city: Los Angeles
country: United States
facility: United States, California
state: California
city: Redding
country: United States
facility: United States, California
state: California
city: San Diego
country: United States
facility: United States, California
state: California
city: Atlanta
country: United States
facility: United States, Georgia
state: Georgia
city: Idaho Falls
country: United States
facility: United States, Idaho
state: Idaho
city: New Orleans
country: United States
facility: United States, Louisiana
state: Louisiana
city: Chevy Chase
country: United States
facility: United States, Maryland
state: Maryland
city: Columbia
country: United States
facility: United States, Maryland
state: Maryland
city: Boston
country: United States
facility: United States, Massachusetts
state: Massachusetts
city: Plymouth
country: United States
facility: United States, Minnesota
state: Minnesota
city: Kansas City
country: United States
facility: United States, Missouri
state: Missouri
city: St. Louis
country: United States
facility: United States, Missouri
state: Missouri
city: Branchburg
country: United States
facility: United States, New Jersey
state: New Jersey
city: Edison
country: United States
facility: United States, New Jersey
state: New Jersey
city: Iselin
country: United States
facility: United States, New Jersey
state: New Jersey
city: Ocean
country: United States
facility: United States, New Jersey
state: New Jersey
city: New York
country: United States
facility: United States, New York
state: New York
city: North Syracuse
country: United States
facility: United States, New York
state: New York
city: Durham
country: United States
facility: United States, North Carolina
state: North Carolina
city: Centerville
country: United States
facility: United States, Ohio
state: Ohio
city: Cincinnati
country: United States
facility: United States, Ohio
state: Ohio
city: Oklahoma City
country: United States
facility: United States, Oklahoma
state: Oklahoma
city: Tulsa
country: United States
facility: United States, Oklahoma
state: Oklahoma
city: Lake Oswego
country: United States
facility: United States, Oregon
state: Oregon
city: Altoona
country: United States
facility: United States, Pennsylvania
state: Pennsylvania
city: Hershey
country: United States
facility: United States, Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: United States, Pennsylvania
state: Pennsylvania
city: Columbia
country: United States
facility: United States, South Carolina
state: South Carolina
city: Rapid City
country: United States
facility: United States, South Dakota
state: South Dakota
city: Dallas
country: United States
facility: United States, Texas
state: Texas
city: Spokane
country: United States
facility: United States, Washington
state: Washington
city: Tacoma
country: United States
facility: United States, Washington
state: Washington
city: Odense C
country: Denmark
facility: Denmark, Odense C
city: Berlin
country: Germany
facility: Germany, Berlin
city: Frankfurt
country: Germany
facility: Germany, Frankfurt
city: Mainz
country: Germany
facility: Germany, Mainz
city: München
country: Germany
facility: Germany, München
city: Luzern 16
country: Switzerland
facility: Switzerland, Luzern 16
Study officials:
affiliation: CSL Behring
name: Global Clinical Program Director
role: STUDY_DIRECTOR
References:
citation: Bygum A, Martinez-Saguer I, Bas M, Rosch J, Edelman J, Rojavin M, Williams-Herman D; Berinert Registry Investigators. Use of a C1 Inhibitor Concentrate in Adults >/=65 Years of Age with Hereditary Angioedema: Findings from the International Berinert(R) (C1-INH) Registry. Drugs Aging. 2016 Nov;33(11):819-827. doi: 10.1007/s40266-016-0403-0.
citation: Busse P, Bygum A, Edelman J, Lumry W, Machnig T, Martinez-Saguer I, Rojavin M. Safety of C1-esterase inhibitor in acute and prophylactic therapy of hereditary angioedema: findings from the ongoing international Berinert patient registry. J Allergy Clin Immunol Pract. 2015 Mar-Apr;3(2):213-9. doi: 10.1016/j.jaip.2014.08.014. Epub 2014 Oct 29.