Hereditary Angioedema (HAE)NCT01541423
A European Post-Authorisation Observational Study Of Patients With Hereditary Angioedema
An observational study of Hereditary Angioedema (HAE), run by Shire at 20 sites in 6 countries.
Trial summary
This observational (non-interventional) study is being conducted to characterize the safety and use of CINRYZE in routine clinical practice when administered for (1) routine prevention of angioedema attacks, (2) pre-procedure prevention of angioedema attacks, and/or (3) treatment of angioedema attacks. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hereditary Angioedema (HAE)
- How many people
- 83 participants
- Where
- 20 sitesin 6 countries
- Study dates
- 11 May 2012to 25 Sep 2016
- 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: Patients with HAE in Europe who are receiving CINRYZE in routine clinical practice for prevention or treatment of angioedema attacks. Approximately 20 sites are planned for enrollment.
Who may be able to join
- All patients must:
- Have a diagnosis of HAE and be receiving CINRYZE for prevention or treatment of angioedema attacks
- Provide written informed consent/assent in compliance with applicable country-specific and local regulations
Who cannot join
- All patients must not:
- Be receiving CINRYZE in an investigational study
- Be receiving another HAE therapy as part of a clinical trial
Trial locations and contacts
20 sites in 6 countries.
20 sites in 6 countries
Germany6 sites
Allergie-Centrum-Charite
Berlin, 10117
Universitätsklinik Essen
Essen, 45122
Johann Wolfgang Goethe Universität
Frankfurt, 60590
Universität-Hautklinik Mainz
Mainz, 55131
Hämophilie-Zentrum Rhein Main
Mörfelden-Walldorf, D-64546
Klinikum rechts der Isar der technischen Universität München
München, 81675
France5 sites
CHU d'Angers
Angers, 49033
Hôpital Claude-Huriez
Lille, 59037
Immunologie Clinique et Allergologie
Nancy, 54500
Hôpital Saint Antoine
Paris, 75571
Université Paris Descartes
Paris, 75679
Spain3 sites
C.A.R San Pedro
Logroño, 26003
Hospital General Universitario
Madrid, 28007
Hospital Universitario La Paz
Madrid, 28046
Belgium2 sites
Universitair Ziekenhuis Antwerpen (UZA)
Antwerp, Edegem, 2650
Clinic St-Luc University Hospital
Brussels
Italy2 sites
Ospedale Luigi Sacco
Milan, 20157
Azienda Ospedaliera "V. Cervello"
Palermo, 90146
United Kingdom2 sites
Barts and the London NHS Trust
London, E1 2ES
Northern General Hospital
Sheffield, S5 7AU
About this study
Official title: A European Multi-Center, Multi-Country, Post-Authorisation, Observational Study (Registry) Of Patients With Hereditary Angioedema (HAE) Who Are Administered CINRYZE® (C1 Inhibitor [Human]) For The Treatment Or Prevention Of HAE Attacks
This observational (non-interventional) study is being conducted to characterize the safety and use of CINRYZE in routine clinical practice when administered for (1) routine prevention of angioedema attacks, (2) pre-procedure prevention of angioedema attacks, and/or (3) treatment of angioedema attacks.
- Conditions
- Hereditary Angioedema (HAE)
- Medical subject headings
- Angioedemas, Hereditary
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse drug reactions
Measured: 12 months
Incidence of thrombotic/thromboembolic events
Measured: 12 months
Occurrence of pregnancy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study start11 May 2012
- Primary completion25 Sep 2016
- Study completion25 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Angioedema (HAE)Studies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541423
- Sponsor's protocol ID
- 0624-401
- Other IDs
- SHP616-401
- Status last verified
- Mar 2021
- First submitted
- 16 Feb 2012
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A European Multi-Center, Multi-Country, Post-Authorisation, Observational Study (Registry) Of Patients With Hereditary Angioedema (HAE) Who Are Administered CINRYZE® (C1 Inhibitor [Human]) For The Treatment Or Prevention Of HAE Attacks
- ClinicalTrials.gov ID
- NCT01541423
- Acronym / sponsor ID
- 0624-401
- Conditions
- Hereditary Angioedema (HAE)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 11 May 2012 (actual)
- Primary completion
- 25 Sep 2016 (actual)
- Study completion
- 25 Sep 2016 (actual)
- First posted
- 1 Mar 2012 (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.
This observational (non-interventional) study is being conducted to characterize the safety and use of CINRYZE in routine clinical practice when administered for (1) routine prevention of angioedema attacks, (2) pre-procedure prevention of angioedema attacks, and/or (3) treatment of angioedema attacks.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with HAE in Europe who are receiving CINRYZE in routine clinical practice for prevention or treatment of angioedema attacks. Approximately 20 sites are planned for enrollment.
Key inclusion criteria (3 listed)
- Have a diagnosis of HAE and be receiving CINRYZE for prevention or treatment of angioedema attacks
- Provide written informed consent/assent in compliance with applicable country-specific and local regulations
Key exclusion criteria (3 listed)
- Be receiving CINRYZE in an investigational study
- Be receiving another HAE therapy as part of a clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of adverse drug reactions
Time frame: 12 months
Incidence of thrombotic/thromboembolic events
Time frame: 12 months
Occurrence of pregnancy
Time frame: 12 months
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 17 Mar 2021.
- To obtain more information on the study, click here/on this link.Link provided by the sponsor.
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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.
Study Director study director
Takeda
20 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hereditary Angioedema (HAE), run by Shire at 20 sites in 6 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 3 inclusion and 3 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 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany, France, Spain, Belgium, Italy and 1 more country. 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 adverse drug reactions (time frame: 12 months). 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?
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 17 Mar 2021.