Firazyr® Patient Registry Protocol (Icatibant Outcome Survey - IOS)
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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) |
- 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 |
- Patients receiving at least one dose of subcutaneous Firazyr®.
- Written informed consent from the patient or, for patients below 18, consent from parents and or patient's legal representative.
Inclusion Criteria:
Each patient must meet the following criteria to be enrolled in this study.
- Patients receiving at least one dose of subcutaneous Firazyr®.
- 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| Contact: Lydie Renault | 41-22-419-4204 | lrenault@shire.com |
Show 45 Study Locations| 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 May 19, 2013