Firazyr® Patient Registry (Icatibant Outcome Survey - IOS)

September 27, 2023 updated by: Shire

Icatibant Outcome Survey (IOS) Registry

The Icatibant Outcome Survey (IOS) is a prospective, observational disease registry designed to document the routine clinical outcomes over time in participants with angioedema treated with Firazyr® (icatibant) and/or Cinryze® (C1 inhibitor [human]) in countries where it is currently approved. The data collected will be used to evaluate the safety of Firazyr (icatibant) and Cinryze (C1 inhibitor [human]) in routine clinical practice and as a data source for post-marketing investigations.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The Icatibant Outcome Survey (IOS) is a multicenter, prospective, observational study for participants treated with Firazyr (icatibant) and/or Cinryze (C1 inhibitor [human]) in countries where it is currently approved. The entry of participants in the Icatibant Outcome Survey (IOS) is at the discretion of the physician and the participant and is not a pre-requisite for prescribing Firazyr (icatibant) or Cinryze (C1 inhibitor [human]).

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

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

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560
        • Recruiting
        • Campbelltown Hospital
        • Contact:
          • Site Contact
          • Phone Number: +61246343000
        • Principal Investigator:
          • Constance Katelaris, MD, PhD
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
        • Contact:
          • Site Contact
          • Phone Number: +61882223369
        • Principal Investigator:
          • William Smith, MD, MBBS, FRACP, FRCPA, Ph.D.
  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Medizinische Universitat Graz
        • Contact:
          • Site Contact
          • Phone Number: +433163809618
        • Principal Investigator:
          • Lukas Koch
  • Brazil
    • São Paulo
      • Santo André, São Paulo, Brazil, 09060-870
        • Recruiting
        • Faculdade de Medicina do ABC
        • Contact:
        • Principal Investigator:
          • Anete Grumach, MD
  • Czechia
      • Brno, Czechia, 656 91
        • Recruiting
        • Fakultni nemocnice u sv. Anny v Brne
        • Contact:
          • Site Contact
          • Phone Number: +420543182658
        • Principal Investigator:
          • Roman Hakl, MD
  • Denmark
      • Odense, Denmark, DK-5000
        • Completed
        • Odense Universitetshospital
  • France
      • Angers Cedex 10, France, 49933
        • Recruiting
        • CHU Angers
        • Contact:
        • Principal Investigator:
          • Ludovic Martin, MD
      • Bordeaux, France, 33076
        • Completed
        • Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin
      • Brest, France, 29609
        • Recruiting
        • CHU La Cavale Blanche
        • Contact:
          • Site Contact
          • Phone Number: +33298347600
        • Principal Investigator:
          • Claire de Moreuil
      • Grenoble, France, 38043
        • Recruiting
        • CHU de GRENOBLE
        • Contact:
          • site contact
          • Phone Number: +33476768947
        • Principal Investigator:
          • Laurence Bouillet, MD
      • Le Mans cedex 9, France, 72037
        • Recruiting
        • Centre Hospitalier Le Mans
        • Contact:
          • Site Contact
          • Phone Number: +33244710750
        • Principal Investigator:
          • Herve Maillard, MD
      • Lille, France, 59037
        • Recruiting
        • CHRU Lille
        • Contact:
          • Site Update
          • Phone Number: +33320445765
        • Principal Investigator:
          • David Launay, MD
      • Lyon, France, 69003
        • Recruiting
        • Groupement Hospitalier Edouard Herriot
        • Contact:
          • Site Contact
          • Phone Number: +33472117565
        • Principal Investigator:
          • Magali Aubineau, MD
      • Montpellier, France, 34295
        • Completed
        • CHU Montpellier - Hopital St Eloi
      • Nancy, France, 54035
        • Completed
        • CHU de Nancy-Hopital Brabois Adulte
      • Nantes, France, 44093
        • Completed
        • Hôtel Dieu - Nantes
      • Nice, France, 6202
        • Recruiting
        • CHU de Nice Archet I
        • Contact:
          • Site Contact
          • Phone Number: +33492035823
        • Principal Investigator:
          • Pierre-Yves Jeandel, MD
      • Niort, France, 79021
        • Recruiting
        • Centre Hospitalier Georges Renon
        • Contact:
        • Principal Investigator:
          • Amandine Perier
      • Paris, France, 75571
        • Recruiting
        • Hopital Saint Antoine
        • Contact:
          • Site Contact
          • Phone Number: +33142160465
        • Principal Investigator:
          • Olivier Fain, MD
      • Paris, France, 75001
        • Completed
        • Hôtel Dieu de Paris Hospital
      • Paris, France, 75679
        • Completed
        • Hôpital Cochin
      • Reims, France, 51000
        • Completed
        • CHU de Reims
      • Saint-Etienne, France, 42100
        • Completed
        • Centre Hospitalier Universitaire de Saint Etienne
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, France, 67098
        • Completed
        • Hopital de Hautepierre
    • Calvados
      • Caen, Calvados, France, 14033
        • Completed
        • Hôpital Côte De Nacre
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Completed
        • Hopital Purpan
  • Germany
      • Berlin, Germany, 12203
        • Recruiting
        • Charité - Universitätsmedizin Berlin
        • Contact:
          • Site Contact
          • Phone Number: +493045050
        • Principal Investigator:
          • Markus Magerl, MD
      • Mörfelden-Walldorf, Germany, 64546
        • Recruiting
        • Hämophilie Zentrum Rhein Main GmbH
        • Principal Investigator:
          • Inmaculada Martinez Saguer
        • Contact:
          • Site Contact
          • Phone Number: +4961059638909
      • Ulm, Germany, 89075
        • Recruiting
        • Universitätsklinikum Ulm
        • Contact:
        • Principal Investigator:
          • Jens Greve, MD
    • Bayern
      • München, Bayern, Germany, 81675
        • Recruiting
        • Hals-Nasen-Ohrenklinik und Poliklinik
        • Principal Investigator:
          • Felix Johnson
        • Contact:
          • Site Contact
          • Phone Number: +498941409592
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Recruiting
        • Klinikum der Johann-Wolfgang Goethe-Universitat
        • Principal Investigator:
          • Emel Aygören-Pürsün, MD
        • Contact:
          • Site Contact
          • Phone Number: +496963016439
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45122
        • Completed
        • Universitätsklinikum Essen
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55101
        • Recruiting
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
        • Contact:
          • Site Contact
          • Phone Number: +496131170
        • Principal Investigator:
          • Petra Staubach-Renz
    • Sachsen
      • Dresden, Sachsen, Germany, 1307
        • Recruiting
        • Universitätsklinikum Carl Gustav Carus an der TU Dresden
        • Contact:
          • Site Contact
          • Phone Number: +493514580
        • Principal Investigator:
          • Andrea Bauer, MD
  • Greece
      • Thessaloniki, Greece, 56429
        • Recruiting
        • Papageorgiou General Hospital of Thessaloniki
        • Contact:
          • Site Contact
          • Phone Number: +302310693350
        • Principal Investigator:
          • Efimia Papadopoulou Alataki, MD
    • Attiki
      • Athens, Attiki, Greece, 11521
        • Recruiting
        • Navy Hospital of Athens
        • Contact:
          • Site Contact
          • Phone Number: +302107261301
        • Principal Investigator:
          • Fotios Psarros, MD
  • Ireland
      • Dublin 8, Ireland
        • Recruiting
        • St James's Hospital
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Niall Conlon
  • Israel
      • Haifa, Israel, 31048
        • Recruiting
        • Bnai Zion Medical Center
        • Principal Investigator:
          • Aharon Kessel
        • Contact:
          • Site Contact
          • Phone Number: 972 549706516
      • Petach Tikva, Israel, 49100
        • Completed
        • Rabin Medical Center - PPDS
      • Ramat-Gan, Israel, 52621
        • Recruiting
        • Sheba Medical Center - PPDS
        • Contact:
          • Site Contact
          • Phone Number: +97235343888
        • Principal Investigator:
          • Nancy Agmon-Levin, MD
      • Tel Aviv, Israel, 64239
        • Recruiting
        • Tel Aviv Sourasky Medical Center PPDS
        • Contact:
          • Site Contact
          • Phone Number: +972524498779
        • Principal Investigator:
          • Shmuel Kivity, MD
  • Italy
      • Padova, Italy, 35128
        • Completed
        • Universita degli Studi di Padova
      • Palermo, Italy, 90146
        • Completed
        • Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello
    • Campania
      • Napoli, Campania, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera Universitaria Federico II
        • Principal Investigator:
          • Giuseppe Spadaro
        • Contact:
          • Site Contact
    • Lombardia
      • Milano, Lombardia, Italy, 20157
        • Recruiting
        • ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
        • Contact:
          • Site Contact
          • Phone Number: +390239042757
        • Principal Investigator:
          • Andrea Zanichelli, MD
    • Puglia
      • Bari, Puglia, Italy, 70124
        • Recruiting
        • AO Ospedale Policlinico Consorziale di Bari
        • Contact:
          • Site Contact
          • Phone Number: +390805592784
        • Principal Investigator:
          • Anna Maria Di Palma, MD
      • Bari, Puglia, Italy, 70124
        • Recruiting
        • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
        • Contact:
          • Site Contact
        • Principal Investigator:
          • Anna Maria Di Palma
    • Sardegna
      • Monserrato, Sardegna, Italy, 9042
        • Recruiting
        • Presidio Policlinico di Monserrato
        • Contact:
        • Principal Investigator:
          • Davide Firinu
  • Spain
      • Barcelona, Spain, 8035
        • Recruiting
        • Hospital Universitario Vall d'Hebron - PPDS
        • Contact:
          • Site Contact
          • Phone Number: +34932746000
        • Principal Investigator:
          • Mar Guilarte, MD, PhD
      • Gijon, Spain, 33202
        • Completed
        • Hospital Cruz Roja Española de Gijón
      • Jaen, Spain, 23007
        • Recruiting
        • Hospital Universitario de Jaén
        • Contact:
          • Site Contact
          • Phone Number: +34953008000
        • Principal Investigator:
          • Blanca Saenz de San Pedro, MD
      • Lleida, Spain, 25198
        • Recruiting
        • Hospital de Santa Maria
        • Contact:
        • Principal Investigator:
          • Lluis Marques, MD
      • Logrono, Spain, 26006
        • Recruiting
        • Centro de Alta Resolución de Procesos Asistenciales (C.A.R.P.A.)
        • Contact:
          • Site Contact
          • Phone Number: +34941296041
        • Principal Investigator:
          • Maria Dolores Del Pozo Gil
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Contact:
          • Site Contact
          • Phone Number: +34915868000
        • Principal Investigator:
          • Maria Luisa Baeza, MD, PhD
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz - PPDS
        • Contact:
          • Site Contact
          • Phone Number: +34917271785
        • Principal Investigator:
          • M Teresa Caballero, MD
      • Madrid, Spain, 28040
        • Completed
        • Hospital Clínico San Carlos
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio - PPDS
        • Contact:
          • Site Contact
          • Phone Number: +34955013622
        • Principal Investigator:
          • Stefan Henning Cimbollek
      • Valencia, Spain, 46009
        • Recruiting
        • Hospital Universitari i Politecnic La Fe de Valencia
        • Contact:
          • Site Contact
          • Phone Number: +34961244084
        • Principal Investigator:
          • Ethel Ibañez
      • Vigo, Spain, 36204
        • Completed
        • Complejo Hospitalario Universitario de Vigo
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15706
        • Completed
        • CHUS - H. Clinico U. de Santiago
    • Alicante
      • Villajoyosa, Alicante, Spain, 03570
        • Recruiting
        • Hospital de La Marina Baixa
        • Contact:
          • Site Contact
          • Phone Number: +34966859800
        • Principal Investigator:
          • Carlos Hernando de Larramendi, MD
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 8907
        • Recruiting
        • Hospital Universitario de Bellvitge
        • Principal Investigator:
          • Ramon Lleonart Bellfill
        • Contact:
  • Sweden
      • Jönköping, Sweden, SE-55185
        • Completed
        • Länssjukhuset Ryhov
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Active, not recruiting
        • Birmingham Heartlands Hospital
      • Cardiff, United Kingdom, CF14 4XW
        • Recruiting
        • University Hospital of Wales - PPDS
        • Contact:
          • Site Contact
          • Phone Number: +442920743444
        • Principal Investigator:
          • Tariq El-Shanawany, MBBS, MD, MRCPCH, MSc
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free Hospital
        • Contact:
          • Site Contact
          • Phone Number: +442079411836
        • Principal Investigator:
          • Suranjith Seneviratne, MD
      • London, United Kingdom, E1 2ES
        • Recruiting
        • The Royal London Hospital
        • Contact:
          • Site Contact
          • Phone Number: +4420737770003382
        • Principal Investigator:
          • Sorena Kiani-Alikhan
      • Manchester, United Kingdom, M13 9WL
        • Active, not recruiting
        • Manchester Royal Infirmary - PPDS
      • Newcastle Upon Tyne, United Kingdom, NE1 4LP
        • Recruiting
        • Royal Victoria Infirmary
        • Contact:
          • Site Contact
          • Phone Number: +441912825452
        • Principal Investigator:
          • Catherine Stroud, MD
      • Plymouth, United Kingdom, PL6 8DH
        • Recruiting
        • Derriford Hospital
        • Contact:
          • Site Contact
          • Phone Number: +441752792555
        • Principal Investigator:
          • Claire Bethune, MD
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • Recruiting
        • Cambridge University Hospitals NHS Foundation Trust
        • Contact:
          • Site Contact
          • Phone Number: +441223400185
        • Principal Investigator:
          • Nishantha Gurugama
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Recruiting
        • John Radcliffe Hospital
        • Contact:
          • Site Contact
          • Phone Number: +441865741166
        • Principal Investigator:
          • Rashmi Jain, MD
    • Surrey
      • Frimley, Surrey, United Kingdom, GU16 7UJ
        • Not yet recruiting
        • Frimley Park Hospital
        • Contact:
          • Site Contact
          • Phone Number: +441276604604
        • Principal Investigator:
          • Patrick Yong
    • York
      • Leeds, York, United Kingdom, LS9 7TF
        • Recruiting
        • St James University Hospital
        • Contact:
          • Site Contact
          • Phone Number: +01132065567
        • Principal Investigator:
          • Sinisa Savic, MD, PhD

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with Type I or II HAE, and, where applicable, with angiotensin-converting enzyme inhibitor (ACE-I)-induced angioedema, non-histaminergic idiopathic angioedema, or acquired angioedema, irrespective of treatment and/or other treatments and also participants who have taken at least 1 dose of Firazyr (Icatibant) or Cinryze (C1 inhibitor [human]) will be included in this study.

Description

Inclusion Criteria:

  1. Diagnosis of at least 1 of the following:

    • Hereditary angioedema (HAE) type I or II
    • HAE with normal C1 inhibitor
    • ACE-I-induced angioedema
    • Non-histaminergic idiopathic angioedema
    • Acquired angioedema.
  2. Signed and dated written informed consent from the participant or, for participants aged less than(<)18 years (or as per local regulation, such as <16 years in the United Kingdom [UK]), parent and/or participants legally authorized representative (LAR), and assent of the minor where applicable.
  3. At sites only participating in the drug registry, participants must have taken at least 1 dose of Firazyr (Icatibant) or Cinryze (C1 inhibitor [human]).
  4. Enrolled participants in Germany taking Firazyr (Icatibant) or Cinryze (C1 inhibitor [human]) will only use the respective product in accordance with the product label.

Exclusion Criteria:

  1. Participants enrolled in clinical trials where the product is blinded or where the product under investigation is for the treatment of HAE, ACE-I-induced angioedema, non-histaminergic idiopathic angioedema, or acquired angioedema.
  2. Participants enrolled in another Shire-sponsored registry involving products for the treatment of HAE, ACE-I-induced angioedema, non-histaminergic idiopathic angioedema, or acquired angioedema. An exception applies to participants enrolled in the Shire lanadelumab ENABLE study.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Participants with hereditary angioedema (HAE)
All participants with hereditary angioedema (HAE) who are administered Cinryze (C1 inhibitor [human]) or Firazyr (Icatibant) for the treatment or prevention of angioedema attacks in routine clinical practice will be included into the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Cardiac Ischemia Events in Participants Predisposed to Cardiac Ischemia Events With Concomitant Firazyr (Icatibant) Administration
Time Frame: From enrollment through study participation (Approximately 13 years)
Incidence of cardiac ischemia events in participants predisposed to cardiac ischemia events with concomitant Firazyr (Icatibant) administration will be assessed.
From enrollment through study participation (Approximately 13 years)
Incidence of Hypotension for Firazyr (Icatibant)
Time Frame: From enrollment through study participation (Approximately 13 years)
Incidence of hypotension for Firazyr (Icatibant) will be assessed.
From enrollment through study participation (Approximately 13 years)
Incidence of Swelling of Mucous Membranes for Firazyr (Icatibant)
Time Frame: From enrollment through study participation (Approximately 13 years)
Incidence of swelling of mucous membranes for Firazyr (Icatibant) will be assessed.
From enrollment through study participation (Approximately 13 years)
Incidence of Bronchoconstriction for Firazyr (Icatibant)
Time Frame: From enrollment through study participation (Approximately 13 years)
Incidence of bronchoconstriction for Firazyr (Icatibant) will be assessed.
From enrollment through study participation (Approximately 13 years)
Incidence of Aggravation of Pain for Firazyr (Icatibant)
Time Frame: From enrollment through study participation (Approximately 13 years)
Incidence of aggravation of pain for Firazyr (Icatibant) will be assessed.
From enrollment through study participation (Approximately 13 years)
Sexual Hormones Level Measurements- Tanner Staging for Firazyr (Icatibant)
Time Frame: From enrollment through study participation (Approximately 13 years)
Effects on sexual maturation in pubertal adolescents will be measured using Tanner staging (pubic hair stage and genital breast stage) for Firazyr (Icatibant).
From enrollment through study participation (Approximately 13 years)
Time to Complete Resolution of the Firazyr (Icatibant)-Treated Laryngeal Attacks
Time Frame: From enrollment through study participation (Approximately 13 years)
Time to complete resolution of the laryngeal attacks will be assessed. It is defined as the time between the first injection of treatment and the complete resolution of all symptoms.
From enrollment through study participation (Approximately 13 years)
Incidence of Adverse Events (AE) Related to Firazyr (Icatibant)-Treated Laryngeal Attacks
Time Frame: From enrollment through study participation (Approximately 13 years)
An AE is defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in the registry, whether or not considered product-related. This includes an exacerbation of a pre-existing condition.
From enrollment through study participation (Approximately 13 years)
Incidence of Adverse Drug Reactions (ADR) for Firazyr (Icatibant)
Time Frame: From enrollment through study participation (Approximately 13 years)
An ADR is a response to a medicinal product that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis, and treatment of disease or for the restoration, correction, or modification of physiological function.
From enrollment through study participation (Approximately 13 years)
Incidence of Serious Adverse Events (SAE) for Firazyr (Icatibant)
Time Frame: From enrollment through study participation (Approximately 13 years)
An AE or ADR that meets 1 or more of the following criteria or outcomes is classified as an SAE whether considered to be related to the pharmaceutical product or not: death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability or incapacity; a congenital anomaly or birth defect; important medical events.
From enrollment through study participation (Approximately 13 years)
Incidence of Pregnancy and Lactation Events During Firazyr (Icatibant) Exposure
Time Frame: From enrollment through study participation (Approximately 13 years)
The incidence of pregnancy or lactation events coinciding with exposure to Firazyr (Icatibant) will be summarized by angioedema treatment and subgroup.
From enrollment through study participation (Approximately 13 years)
Incidence of Adverse Events (AE) for Cinryze (C1 Inhibitor [Human])
Time Frame: From enrollment through study participation (Approximately 13 years)
An AE is defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in the registry, whether or not considered product-related. This includes an exacerbation of a pre-existing condition.
From enrollment through study participation (Approximately 13 years)
Incidence of Adverse Drug Reactions (ADR) for Cinryze (C1 Inhibitor [Human])
Time Frame: From enrollment through study participation (Approximately 13 years)
An ADR is a response to a medicinal product that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis, and treatment of disease or for the restoration, correction, or modification of physiological function.
From enrollment through study participation (Approximately 13 years)
Incidence of Serious Adverse Events (SAE) for Cinryze (C1 Inhibitor [Human])
Time Frame: From enrollment through study participation (Approximately 13 years)
An AE or ADR that meets 1 or more of the following criteria or outcomes is classified as an SAE whether considered to be related to the pharmaceutical product or not: death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability or incapacity; a congenital anomaly or birth defect; important medical events.
From enrollment through study participation (Approximately 13 years)
Incidence of Thrombotic or Thromboembolic Events for Cinryze (C1 Inhibitor [Human])
Time Frame: From enrollment through study participation (Approximately 13 years)
Thrombotic or thromboembolic events will be reported as SAEs and will include, but are not limited to, established diagnoses of any of the following: renal allograft arterial or venous thrombosis; deep vein thrombosis; myocardial infarction; pulmonary embolism; Ischemic cerebrovascular accident (stroke)- cerebrovascular accident exclusive of cerebrovascular hemorrhage (subarachnoid or subdural hemorrhage); any large vessel thrombosis; thrombophlebitis; catheter-related thrombotic events (including clotted dialysis access grafts) will be assessed.
From enrollment through study participation (Approximately 13 years)
Incidence of Pregnancy and Lactation Events During Cinryze (C1 Inhibitor [Human]) Exposure
Time Frame: From enrollment through study participation (Approximately 13 years)
The incidence of pregnancy or lactation events coinciding with exposure to Cinryze (C1 inhibitor [human]) will be summarized by angioedema treatment and subgroup.
From enrollment through study participation (Approximately 13 years)
Drug Exposure Data for Cinryze (C1 Inhibitor [Human])
Time Frame: From enrollment through study participation (Approximately 13 years)
Drug exposure data for Cinryze (C1 inhibitor [human]) for prophylaxis, pre-procedural, and acute treatments will be reported.
From enrollment through study participation (Approximately 13 years)
Frequency of Hereditary Angioedema (HAE) Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human])
Time Frame: From enrollment through study participation (Approximately 13 years)
Frequency of HAE attacks in participants treated with Cinryze (C1 inhibitor [human]) will be assessed.
From enrollment through study participation (Approximately 13 years)
Severity of Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human])
Time Frame: From enrollment through study participation (Approximately 13 years)
Severity of HAE attacks in participants treated with Cinryze (C1 inhibitor [human]) will be assessed.
From enrollment through study participation (Approximately 13 years)
Anatomic Location of Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human])
Time Frame: From enrollment through study participation (Approximately 13 years)
Anatomic location of HAE attacks in participants treated with Cinryze (C1 inhibitor [human]) will be assessed.
From enrollment through study participation (Approximately 13 years)
Outcome of Severe or Laryngeal Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human])
Time Frame: From enrollment through study participation (Approximately 13 years)
Outcome of severe or laryngeal HAE attacks in participants treated with Cinryze (C1 inhibitor [human]) will be assessed.
From enrollment through study participation (Approximately 13 years)
Outcome of Hereditary Angioedema Attacks for Treatment With Cinryze (C1 Inhibitor [Human])
Time Frame: From enrollment through study participation (Approximately 13 years)
Outcome of HAE attacks for treatment with Cinryze (C1 inhibitor [human]) which was initiated more than 4 hours after onset of the attack will be reported.
From enrollment through study participation (Approximately 13 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Treatment For Attack
Time Frame: From enrollment through study participation (Approximately 13 years)
Time to treatment for attack will be assessed. It is defined as the time between the onset of the attack and the first injection of treatment.
From enrollment through study participation (Approximately 13 years)
Time to Complete Resolution of Attack
Time Frame: From enrollment through study participation (Approximately 13 years)
Time to complete resolution of attack will be assessed. It is defined as the time between the first injection of treatment and the complete resolution of all symptoms.
From enrollment through study participation (Approximately 13 years)
Total Duration of Attack
Time Frame: From enrollment through study participation (Approximately 13 years)
Total duration of attack will be assessed. It is defined as the time between the onset of the attack and the complete resolution of all symptoms
From enrollment through study participation (Approximately 13 years)
Hereditary Angioedema-Treated Attacks
Time Frame: From enrollment through study participation (Approximately 13 years)
The frequency, severity, and affected sites of HAE-treated attacks will be reported.
From enrollment through study participation (Approximately 13 years)

Collaborators and Investigators

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

Sponsor

Shire

Collaborators

Takeda Development Center Americas, Inc.

Investigators

  • Study Director: Study Director, Takeda Development Center Americas

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 (Actual)

July 10, 2009

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

December 17, 2009

First Submitted That Met QC Criteria

December 17, 2009

First Posted (Estimated)

December 18, 2009

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JE049-5134

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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