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NCT01541423 Clinical Trial

A European Post-Authorisation Observational Study Of Patients With Hereditary Angioedema

Hereditary Angioedema (HAE) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01541423
Other study ID # 0624-401
Secondary ID SHP616-401
Status Completed
Phase
First received
Last updated
Start date May 11, 2012
Est. completion date September 25, 2016

Study information
Verified date March 2021
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 83
Est. completion date September 25, 2016
Est. primary completion date September 25, 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria 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 Exclusion Criteria All patients must not: - Be receiving CINRYZE in an investigational study - Be receiving another HAE therapy as part of a clinical trial

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium Universitair Ziekenhuis Antwerpen (UZA) Antwerp Edegem
Belgium Clinic St-Luc University Hospital Brussels
France CHU d'Angers Angers
France Hôpital Claude-Huriez Lille
France Immunologie Clinique et Allergologie Nancy
France Hôpital Saint Antoine Paris
France Université Paris Descartes Paris
Germany Allergie-Centrum-Charite Berlin
Germany Universitätsklinik Essen Essen
Germany Johann Wolfgang Goethe Universität Frankfurt
Germany Universität-Hautklinik Mainz Mainz
Germany Hämophilie-Zentrum Rhein Main Mörfelden-Walldorf
Germany Klinikum rechts der Isar der technischen Universität München München
Italy Ospedale Luigi Sacco Milano
Italy Azienda Ospedaliera "V. Cervello" Palermo
Spain C.A.R San Pedro Logrono
Spain Hospital General Universitario Madrid
Spain Hospital Universitario La Paz Madrid
United Kingdom Barts and the London NHS Trust London
United Kingdom Northern General Hospital Sheffield

Sponsors (1)
Lead Sponsor Collaborator
Shire

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of adverse drug reactions 12 months
Primary Incidence of thrombotic/thromboembolic events 12 months
Primary Occurrence of pregnancy 12 months
See also
  Status Clinical Trial Phase
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Completed NCT04861090 - A Study in Teenagers and Adults With Hereditary Angioedema (HAE) Type I or Type II Who Use Lanadelumab as Long-Term Prophylaxis
Recruiting NCT05489640 - A Study in Adults With Hereditary Angioedema (HAE) Who Currently Receive Icatibant at Home
Completed NCT02584959 - Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1 Esterase Inhibitor for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema Phase 3
Completed NCT01826916 - EDEMA2: Evaluation of DX-88's Effect in Mitigating Angioedema Phase 2
Completed NCT04057131 - FIRAZYR General Drug Use-Results Survey (Japan)
Recruiting NCT05819775 - CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema Phase 3
Recruiting NCT05397431 - A Survey of Lanadelumab in Participants With Hereditary Angioedema
Completed NCT02741596 - Long-term Safety and Efficacy Study of DX-2930 (SHP643) to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE Phase 3
Completed NCT02093923 - A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants Phase 1
Completed NCT03845400 - A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II in North America
Completed NCT02586805 - Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE Phase 3
Completed NCT02052141 - Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema Phase 3
Completed NCT03888755 - A Study of Icatibant for Acute Attacks of Hereditary Angioedema in Japanese Participants Phase 3
Recruiting NCT05147181 - A Study With Lanadelumab in Persons With Hereditary Angioedema (HAE) in Poland
Recruiting NCT05469789 - A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE)
Completed NCT05460325 - A Study of Lanadelumab (SHP643) in Chinese Participants With Hereditary Angioedema (HAE) Phase 3
Completed NCT01095510 - CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12 Phase 2
Recruiting NCT05578417 - A Study to Review the Treatment and Outcomes of Teenagers and Adults With Non-histaminergic Angioedema With Normal C1 Inhibitor in Canada
Withdrawn NCT01253382 - Study to Evaluate Ecallantide in Paediatric Patients With Acute Attacks of Hereditary Angioedema Phase 2/Phase 3

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