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Patient Registry Study of Berinert® in Normal Clinical Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01108848
Recruitment Status : Completed
First Posted : April 22, 2010
Last Update Posted : June 9, 2014
Chiltern International Inc.
Information provided by (Responsible Party):
CSL Behring

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.

Condition or disease Intervention/treatment
Includes: Hereditary Angioedema Biological: Berinert® (C1 Esterase Inhibitor)

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Study Type : Observational
Actual Enrollment : 318 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Registry for Berinert®, a C1-Esterase Inhibitor
Study Start Date : April 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Group/Cohort Intervention/treatment
Patients requiring treatment with Berinert®
Biological: Berinert® (C1 Esterase Inhibitor)
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.
Other Names:
  • C1-INH
  • Berinert P
  • CE1145

Primary Outcome Measures :
  1. Incidence of thrombotic and thrombo-embolic events [ Time Frame: Within 30 days of treatment with Berinert® ]
  2. Occurrence of suspected viral transmission [ Time Frame: Duration of the study, at least 3 years ]
  3. Use of concomitant medications and plasma products [ Time Frame: Duration of the study, at least 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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®

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01108848

  Show 40 Study Locations
Sponsors and Collaborators
CSL Behring
Chiltern International Inc.
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Study Director: Global Clinical Program Director CSL Behring

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: CSL Behring Identifier: NCT01108848     History of Changes
Other Study ID Numbers: CE1145_5002
1500 ( Other Identifier: CSL Behring )
First Posted: April 22, 2010    Key Record Dates
Last Update Posted: June 9, 2014
Last Verified: June 2014

Keywords provided by CSL Behring:
C1-esterase Inhibitor
Hereditary angioedema
Acute HAE attack

Additional relevant MeSH terms:
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Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Immune System Diseases
Genetic Diseases, Inborn
Complement C1s
Complement C1 Inhibitor Protein
Complement C1 Inactivator Proteins
Immunologic Factors
Physiological Effects of Drugs
Complement Inactivating Agents
Immunosuppressive Agents