Patient Registry Study of Berinert® in Normal Clinical Practice

June 5, 2014 updated by: CSL Behring

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
318

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense C, Denmark, 5000
        • Denmark, Odense C
  • Germany
      • Berlin, Germany, 10117
        • Germany, Berlin
      • Frankfurt, Germany, 60596
        • Germany, Frankfurt
      • Mainz, Germany, 55101
        • Germany, Mainz
      • München, Germany, 81675
        • Germany, München
  • Switzerland
      • Luzern 16, Switzerland, CH-6000
        • Switzerland, Luzern 16
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • United States, Arizona
    • California
      • Granada Hills, California, United States, 91344
        • United States, California
      • Los Angeles, California, United States, 90095
        • United States, California
      • Redding, California, United States, 96003
        • United States, California
      • San Diego, California, United States, 92093
        • United States, California
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • United States, Georgia
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • United States, Idaho
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
        • United States, Louisiana
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • United States, Maryland
      • Columbia, Maryland, United States, 21044
        • United States, Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • United States, Massachusetts
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • United States, Minnesota
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • United States, Missouri
      • St. Louis, Missouri, United States, 63110
        • United States, Missouri
    • New Jersey
      • Branchburg, New Jersey, United States, 08876
        • United States, New Jersey
      • Edison, New Jersey, United States, 88220
        • United States, New Jersey
      • Iselin, New Jersey, United States, 08830
        • United States, New Jersey
      • Ocean, New Jersey, United States, 07712
        • United States, New Jersey
    • New York
      • New York, New York, United States, 10029
        • United States, New York
      • North Syracuse, New York, United States, 13212
        • United States, New York
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • United States, North Carolina
    • Ohio
      • Centerville, Ohio, United States, 45458
        • United States, Ohio
      • Cincinnati, Ohio, United States, 45267
        • United States, Ohio
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73131
        • United States, Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • United States, Oklahoma
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
        • United States, Oregon
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16601
        • United States, Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • United States, Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • United States, Pennsylvania
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • United States, South Carolina
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • United States, South Dakota
    • Texas
      • Dallas, Texas, United States, 75231
        • United States, Texas
    • Washington
      • Spokane, Washington, United States, 99204
        • United States, Washington
      • Tacoma, Washington, United States, 98405
        • United States, Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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®

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:
  • Berinert P
  • CE1145
  • C1-INH

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of thrombotic and thrombo-embolic events
Time Frame: Within 30 days of treatment with Berinert®
Within 30 days of treatment with Berinert®
Occurrence of suspected viral transmission
Time Frame: Duration of the study, at least 3 years
Duration of the study, at least 3 years
Use of concomitant medications and plasma products
Time Frame: Duration of the study, at least 3 years
Duration of the study, at least 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CSL Behring

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chiltern International Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CE1145_5002
  • 1500 (CSL Behring)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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