Patient Registry Study of Berinert® in Normal Clinical Practice

This study has been completed.
Sponsor:
Collaborator:
Chiltern International Inc.
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT01108848
First received: April 12, 2010
Last updated: June 5, 2014
Last verified: June 2014

April 12, 2010
June 5, 2014
April 2010
April 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01108848 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Patient Registry Study of Berinert® in Normal Clinical Practice
Patient Registry for Berinert®, a C1-Esterase Inhibitor

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Includes: Hereditary Angioedema
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
Berinert
Patients requiring treatment with Berinert®
Intervention: Biological: Berinert® (C1 Esterase Inhibitor)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
318
April 2014
April 2014   (final data collection date for primary outcome measure)

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®
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Denmark,   Germany,   Switzerland
 
NCT01108848
CE1145_5002, 1500
No
CSL Behring
CSL Behring
Chiltern International Inc.
Study Director: Global Clinical Program Director CSL Behring
CSL Behring
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP