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

This study is currently recruiting participants.
Verified February 2013 by Shire Human Genetic Therapies, Inc.
Sponsor:
Collaborator:
Shire Orphan Therapies GmbH
Information provided by (Responsible Party):
Shire Human Genetic Therapies, Inc.
ClinicalTrials.gov Identifier:
NCT01034969
First received: December 17, 2009
Last updated: February 11, 2013
Last verified: February 2013
  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
Angioedemas, Hereditary

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 Human Genetic Therapies, Inc.:

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

Estimated Enrollment: 500
Study Start Date: May 2009
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: May 2020 (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

Genders Eligible for Study:   Both
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 the following criteria to be enrolled in this study.

  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.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study.

1. Patients enrolled in trials where the product is blinded or where the product is for the treatment of HAE.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034969

Contacts
Contact: Lydie Renault 41-22-419-4204 lrenault@shire.com

  Show 45 Study Locations
Sponsors and Collaborators
Shire Human Genetic Therapies, Inc.
Shire Orphan Therapies GmbH
Investigators
Study Director: Clement Olivier, MD Shire Human Genetic Therapies, Inc.
  More Information

No publications provided

Responsible Party: Shire Human Genetic Therapies, Inc.
ClinicalTrials.gov Identifier: NCT01034969     History of Changes
Other Study ID Numbers: JE049-5134
Study First Received: December 17, 2009
Last Updated: February 11, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Shire Human Genetic Therapies, Inc.:
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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014