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Patient Registry Study of Berinert® in Normal Clinical Practice

This study is currently recruiting participants.
Verified May 2013 by CSL Behring
Sponsor:
Collaborator:
Chiltern International Inc.
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT01108848
First received: April 12, 2010
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Includes: Hereditary Angioedema
 Biological: Berinert® (C1 Esterase Inhibitor)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Registry for Berinert®, a C1-Esterase Inhibitor

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CSL Behring:

Primary Outcome Measures:
  • Incidence of thrombotic and thrombo-embolic events [ Time Frame: Within 30 days of treatment with Berinert® ] [ Designated as safety issue: Yes ]
  • Occurrence of suspected viral transmission [ Time Frame: Duration of the study, at least 3 years ] [ Designated as safety issue: Yes ]
  • Use of concomitant medications and plasma products [ Time Frame: Duration of the study, at least 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: April 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Berinert
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

  Eligibility

Genders Eligible for Study:   Both
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.

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®
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108848

Contacts
Contact: Clinical Trial Registration Coordinator clinicaltrials@cslbehring.com

  Show 35 Study Locations
Sponsors and Collaborators
CSL Behring
Chiltern International Inc.
Investigators
Study Director: Global Clinical Program Director CSL Behring
  More Information

Additional Information:
Hereditary Angioedema Association (HAEA)  This link exits the ClinicalTrials.gov site
Click here to request more information about this study  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT01108848     History of Changes
Other Study ID Numbers: CE1145_5002, 1500
Study First Received: April 12, 2010
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 21, 2013