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Firazyr® Patient Registry Protocol (Icatibant Outcome Survey - IOS)

This study is currently recruiting participants.
Verified January 2017 by Shire
Sponsor:
ClinicalTrials.gov Identifier:
NCT01034969
First Posted: December 18, 2009
Last Update Posted: January 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Shire
  Purpose
The Firazyr® Patient Registry is a prospective, observational study designed to document the routine clinical outcomes over time in patients treated with Firazyr® in countries where it is currently approved. The data collected will be used to evaluate the safety of Firazyr® in routine clinical practice and as a data source for post-marketing investigations.

Condition
Hereditary Angioedema (HAE)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Firazyr® Patient Registry Protocol (Icatibant Outcome Survey - IOS)

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • To monitor the safety of Firazyr® during long-term treatment [ Time Frame: Non-interventional patient registry ]

Estimated Enrollment: 3000
Study Start Date: May 2009
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
Non-interventional patient registry
Non-interventional patient registry

Detailed Description:
The Firazyr® Patient Registry is a multicenter, prospective, observational study for patients treated with Firazyr® in countries where it is currently approved. The entry of patients into the Firazyr® Registry is at the discretion of the physician and the patient and is not a pre-requisite for prescribing Firazyr®.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  1. Patients receiving at least one dose of subcutaneous Firazyr®.
  2. Written informed consent from the patient or, for patients below 18, consent from parents and or patient's legal representative.
Criteria

Inclusion Criteria:

Each patient must meet all of the following criteria to be enrolled in this registry.

  1. Diagnosis of at least 1 of the following:

    • 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 patient or, for patients aged <18 years (or as per local regulation, such as <16 years in the United Kingdom [UK]), parent and/or patient's legally authorized representative (LAR), and assent of the minor where applicable
  3. At sites only participating in the drug registry aspect of this study, patients must have taken at least 1 dose of Firazyr (icatibant).

Exclusion Criteria:

  1. Patients 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. Patients enrolled in another Shire-sponsored registry involving products for the treatment of HAE, ACE I induced angioedema, non histaminergic idiopathic angioedema, or acquired angioedema.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034969


Contacts
Contact: Shire Contact clinicaltransparency@shire.com

  Show 59 Study Locations
Sponsors and Collaborators
Shire
Investigators
Study Director: Shire Physician Shire
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01034969     History of Changes
Other Study ID Numbers: JE049-5134
First Submitted: December 17, 2009
First Posted: December 18, 2009
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Shire:
Hereditary angioedema

Additional relevant MeSH terms:
Angioedema
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Genetic Diseases, Inborn
Icatibant
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Bradykinin B2 Receptor Antagonists
Bradykinin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors