Includes: Hereditary AngioedemaNCT01108848
Patient Registry Study of Berinert® in Normal Clinical Practice
An observational study of Includes: Hereditary Angioedema, run by CSL Behring at 40 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Includes: Hereditary Angioedema
- What is being tested?
- Berinert® (C1 Esterase Inhibitor)
- How many people
- 318 participants
- Where
- 40 sitesin 4 countries
- Study dates
- Apr 2010to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Any patient receiving CSL Behring's C1-esterase inhibitor
- Written informed consent (may not be required for some retrospective chart review cases)
Who cannot join
- Any patient participating in an HAE study using other C1-inhibitors than Berinert®
Trial locations and contacts
40 sites in 4 countries.
40 sites in 4 countries
United States34 sites
United States, Pennsylvania
Altoona, Pennsylvania, 16601
United States, Georgia
Atlanta, Georgia, 30342
United States, Massachusetts
Boston, Massachusetts, 02115
United States, New Jersey
Branchburg, New Jersey, 08876
United States, Ohio
Centerville, Ohio, 45458
United States, Maryland
Chevy Chase, Maryland, 20815
United States, Ohio
Cincinnati, Ohio, 45267
United States, Maryland
Columbia, Maryland, 21044
United States, South Carolina
Columbia, South Carolina, 29203
United States, Texas
Dallas, Texas, 75231
United States, North Carolina
Durham, North Carolina, 27710
United States, New Jersey
Edison, New Jersey, 88220
United States, California
Granada Hills, California, 91344
United States, Pennsylvania
Hershey, Pennsylvania, 17033
United States, Idaho
Idaho Falls, Idaho, 83404
United States, New Jersey
Iselin, New Jersey, 08830
United States, Missouri
Kansas City, Missouri, 64108
United States, Oregon
Lake Oswego, Oregon, 97035
United States, California
Los Angeles, California, 90095
United States, Louisiana
New Orleans, Louisiana, 70118
United States, New York
New York, New York, 10029
United States, New York
North Syracuse, New York, 13212
United States, New Jersey
Ocean City, New Jersey, 07712
United States, Oklahoma
Oklahoma City, Oklahoma, 73131
United States, Pennsylvania
Pittsburgh, Pennsylvania, 15213
United States, Minnesota
Plymouth, Minnesota, 55446
United States, South Dakota
Rapid City, South Dakota, 57702
United States, California
Redding, California, 96003
United States, California
San Diego, California, 92093
United States, Arizona
Scottsdale, Arizona, 85251
United States, Washington
Spokane, Washington, 99204
United States, Missouri
St Louis, Missouri, 63110
United States, Washington
Tacoma, Washington, 98405
United States, Oklahoma
Tulsa, Oklahoma, 74133
Germany4 sites
Germany, Berlin
Berlin, 10117
Germany, Frankfurt
Frankfurt, 60596
Germany, Mainz
Mainz, Germany, 55101
Germany, München
München, 81675
About this study
Official title: 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.
- Conditions
- Includes: Hereditary Angioedema
- Being tested
- Berinert® (C1 Esterase Inhibitor)
- Keywords
- C1-esterase Inhibitor, Hereditary angioedema, Acute HAE attack
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berinert® (C1 Esterase Inhibitor)Biological
Also called C1-INH, Berinert P, CE1145
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.
| Study group | Role | What they receive |
|---|---|---|
| Berinert | Patients requiring treatment with Berinert® Receives: Biological: Berinert® (C1 Esterase Inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of thrombotic and thrombo-embolic events
Measured: Within 30 days of treatment with Berinert®
Occurrence of suspected viral transmission
Measured: Duration of the study, at least 3 years
Use of concomitant medications and plasma products
Measured: Duration of the study, at least 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Includes: Hereditary AngioedemaStudies of the same condition, open and under way.
- More trials run by CSL BehringThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chiltern International Inc.
- Responsible party
- Sponsor
- Investigators
- Global Clinical Program Director, Study director, CSL Behring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108848
- Sponsor's protocol ID
- CE1145_5002
- Other IDs
- 1500
- Status last verified
- Jun 2014
- First submitted
- 12 Apr 2010
- Last updated
- 9 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Bygum A, Martinez-Saguer I, Bas M, Rosch J, Edelman J, Rojavin M, Williams-Herman D; Berinert Registry Investigators. Use of a C1 Inhibitor Concentrate in Adults >/=65 Years of Age with Hereditary Angioedema: Findings from the International Berinert(R) (C1-INH) Registry. Drugs Aging. 2016 Nov;33(11):819-827. doi: 10.1007/s40266-016-0403-0.
PubMed 27699634Busse P, Bygum A, Edelman J, Lumry W, Machnig T, Martinez-Saguer I, Rojavin M. Safety of C1-esterase inhibitor in acute and prophylactic therapy of hereditary angioedema: findings from the ongoing international Berinert patient registry. J Allergy Clin Immunol Pract. 2015 Mar-Apr;3(2):213-9. doi: 10.1016/j.jaip.2014.08.014. Epub 2014 Oct 29.
PubMed 25609333
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Registry for Berinert®, a C1-Esterase Inhibitor
- ClinicalTrials.gov ID
- NCT01108848
- Acronym / sponsor ID
- CE1145_5002
- Conditions
- Includes: Hereditary Angioedema
- Keywords
- C1-esterase Inhibitor, Hereditary angioedema, Acute HAE attack
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Collaborators
- Chiltern International Inc.
- Study start
- Apr 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 22 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Berinert | – | Biological: Berinert® (C1 Esterase Inhibitor)Patients requiring treatment with Berinert® |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Any patient receiving CSL Behring's C1-esterase inhibitor
- Written informed consent (may not be required for some retrospective chart review cases)
Key exclusion criteria (1 listed)
- Any patient participating in an HAE study using other C1-inhibitors than Berinert®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Berinert® (C1 Esterase Inhibitor)Also: C1-INH, Berinert P, CE1145Berinert® 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. | Biological | Berinert |
Primary outcome
Incidence of thrombotic and thrombo-embolic events
Time frame: Within 30 days of treatment with Berinert®
Occurrence of suspected viral transmission
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
- Derived from this study: PubMed 27699634Bygum A, Martinez-Saguer I, Bas M, Rosch J, Edelman J, Rojavin M, Williams-Herman D; Berinert Registry Investigators. Use of a C1 Inhibitor Concentrate in Adults >/=65 Years of Age with Hereditary Angioedema: Findings from the International Berinert(R) (C1-INH) Registry. Drugs Aging. 2016 Nov;33(11):819-827. doi: 10.1007/s40266-016-0403-0.
- Derived from this study: PubMed 25609333Busse P, Bygum A, Edelman J, Lumry W, Machnig T, Martinez-Saguer I, Rojavin M. Safety of C1-esterase inhibitor in acute and prophylactic therapy of hereditary angioedema: findings from the ongoing international Berinert patient registry. J Allergy Clin Immunol Pract. 2015 Mar-Apr;3(2):213-9. doi: 10.1016/j.jaip.2014.08.014. Epub 2014 Oct 29.
- Hereditary Angioedema Association (HAEA)Link provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Program Director study director
CSL Behring
40 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Includes: Hereditary Angioedema, run by CSL Behring at 40 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Germany, Denmark, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of thrombotic and thrombo-embolic events (time frame: Within 30 days of treatment with Berinert®). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01108848, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2014.