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Patient Registry Study of Berinert® in Normal Clinical Practice

NCT01108848 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 318

Last updated 2014-06-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Chiltern International Inc.

    collaborator INDUSTRY

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Global Clinical Program Director · CSL Behring

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States
  • Denmark
  • Germany
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01108848 on ClinicalTrials.gov