Patient Registry Study of Berinert® in Normal Clinical Practice

NCT01108848 | Completed

• 2 other identifiers: CE1145_50021500
• Study Type: observational
• Target: 318
• Locations: 4 countries
• Sites: 40

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.

Conditions

Includes: Hereditary Angioedema

Keywords

C1-esterase Inhibitor; Hereditary angioedema; Acute HAE attack

Outcome Measures

Primary Outcomes (3)

• Incidence of thrombotic and thrombo-embolic events

  Within 30 days of treatment with Berinert®

• Occurrence of suspected viral transmission

  Duration of the study, at least 3 years

• Use of concomitant medications and plasma products

  Duration of the study, at least 3 years

Study Arms (1)

Berinert

Patients requiring treatment with Berinert®

Biological: Berinert® (C1 Esterase Inhibitor)

Interventions

Berinert® (C1 Esterase Inhibitor) BIOLOGICAL

Berinert® is marketed as a lyophilized concentrate available in a single-use vial to be reconstituted with sterile water before administration as described in the prescribing information.

Also known as: C1-INH, Berinert P, CE1145

Berinert

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• CSL Behring: lead
• Chiltern International Inc.: collaborator

Study Sites (40)

United States, Arizona

Scottsdale, Arizona, 85251, United States

Location

United States, California

Granada Hills, California, 91344, United States

Location

United States, California

Los Angeles, California, 90095, United States

Location

United States, California

Redding, California, 96003, United States

Location

United States, California

San Diego, California, 92093, United States

Location

United States, Georgia

Atlanta, Georgia, 30342, United States

Location

United States, Idaho

Idaho Falls, Idaho, 83404, United States

Location

United States, Louisiana

New Orleans, Louisiana, 70118, United States

Location

United States, Maryland

Chevy Chase, Maryland, 20815, United States

Location

United States, Maryland

Columbia, Maryland, 21044, United States

Location

United States, Massachusetts

Boston, Massachusetts, 02115, United States

Location

United States, Minnesota

Plymouth, Minnesota, 55446, United States

Location

United States, Missouri

Kansas City, Missouri, 64108, United States

Location

United States, Missouri

St Louis, Missouri, 63110, United States

Location

United States, New Jersey

Branchburg, New Jersey, 08876, United States

Location

United States, New Jersey

Edison, New Jersey, 88220, United States

Location

United States, New Jersey

Iselin, New Jersey, 08830, United States

Location

United States, New Jersey

Ocean City, New Jersey, 07712, United States

Location

United States, New York

New York, New York, 10029, United States

Location

United States, New York

North Syracuse, New York, 13212, United States

Location

United States, North Carolina

Durham, North Carolina, 27710, United States

Location

United States, Ohio

Centerville, Ohio, 45458, United States

Location

United States, Ohio

Cincinnati, Ohio, 45267, United States

Location

United States, Oklahoma

Oklahoma City, Oklahoma, 73131, United States

Location

United States, Oklahoma

Tulsa, Oklahoma, 74133, United States

Location

United States, Oregon

Lake Oswego, Oregon, 97035, United States

Location

United States, Pennsylvania

Altoona, Pennsylvania, 16601, United States

Location

United States, Pennsylvania

Hershey, Pennsylvania, 17033, United States

Location

United States, Pennsylvania

Pittsburgh, Pennsylvania, 15213, United States

Location

United States, South Carolina

Columbia, South Carolina, 29203, United States

Location

United States, South Dakota

Rapid City, South Dakota, 57702, United States

Location

United States, Texas

Dallas, Texas, 75231, United States

Location

United States, Washington

Spokane, Washington, 99204, United States

Location

United States, Washington

Tacoma, Washington, 98405, United States

Location

Denmark, Odense C

Odense C, 5000, Denmark

Location

Germany, Mainz

Mainz, Germany, 55101, Germany

Location

Germany, Berlin

Berlin, 10117, Germany

Location

Germany, Frankfurt

Frankfurt, 60596, Germany

Location

Germany, München

München, 81675, Germany

Location

Switzerland, Luzern 16

Lucerne, CH-6000, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 27699634 DERIVED

• 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.

  PMID: 25609333 DERIVED

Related Links

• Hereditary Angioedema Association (HAEA)

MeSH Terms

Conditions

Angioedemas, Hereditary

Interventions

Complement C1 Inhibitor Protein

Condition Hierarchy (Ancestors)

Angioedema; Vascular Diseases; Cardiovascular Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Immunologic Deficiency Syndromes

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Complement C1 Inactivator Proteins; Serpins; Peptides; Amino Acids, Peptides, and Proteins; Complement Inactivator Proteins; Complement System Proteins; Immunoproteins; Blood Proteins; Proteins

Study Officials

• Global Clinical Program Director

  CSL Behring

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 22, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 9, 2014

Record last verified: 2014-06

Locations

DE (4); CH (1); US (34); DK (1)