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FIRAZYR General Drug Use-Results Survey (Japan)

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.
 
ClinicalTrials.gov Identifier: NCT04057131
Recruitment Status : Recruiting
First Posted : August 15, 2019
Last Update Posted : March 10, 2022
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Takeda ( Shire )

Study Description
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Brief Summary:
The objectives of this survey are to collect data to report the safety and efficacy of Firazyr (Icatibant acetate) in the post-marketing phase in participants diagnosed with Hereditary Angioedema (HAE).

Condition or disease Intervention/treatment
Hereditary Angioedema (HAE) Drug: Firazyr

Detailed Description:
FIRAZYR General Drug Use-Results Survey (Japan)
Study Design
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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: FIRAZYR General Drug Use-Results Survey (Japan)
Actual Study Start Date : May 9, 2019
Estimated Primary Completion Date : November 23, 2022
Estimated Study Completion Date : November 23, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Firazyr
Participants with Hereditary angioedema (HAE) receiving treatment with Icatibant acetate (Firazyr) as prescribed by their physician following locally approved prescribing information.
 Drug: Firazyr
Participants with Hereditary angioedema (HAE) receiving treatment with Icatibant acetate (Firazyr) as prescribed by their physician following locally approved prescribing information.
Other Name: Icatibant acetate


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Adverse Drug Reactions [ Time Frame: 4 Years ]
    Number of participants with adverse drug reactions will be assessed.

  2. Time to Treatment for Attack [ Time Frame: 3 Months ]
    Time to treatment for attack defined as the time between the onset of the attack and the first injection of treatment. Time to treatment for attack will be assessed.

  3. Time to First Symptom Relief [ Time Frame: 3 Months ]
    Time to first symptom relief will be assessed.

  4. Time to Complete Resolution of Attack [ Time Frame: 3 Months ]
    Time to complete resolution of attack defined as the time between the first injection of treatment and the complete resolution of all symptoms. Time to complete resolution of attack will be assessed.

  5. Total Duration of Attack [ Time Frame: 3 Months ]
    Total duration of attack defined as the time between the onset of the attack and the complete resolution of all symptoms. Total duration of attack will be assessed.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hereditary angioedema (HAE) patients in Japan who receive FIRAZYR for first time in the real world clinical setting are eligible for enrollment in this survey.
Criteria

Inclusion Criteria:

  • Hereditary angioedema (HAE) participants in Japan who receive FIRAZYR for first time in the real world clinical setting.

Exclusion Criteria

Contacts and Locations
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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): NCT04057131


Contacts
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Contact: Shire Contact +1 866 842 5335 ClinicalTransparency@shire.com

Locations
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Sponsors and Collaborators
Shire
Takeda
Investigators
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Study Director: Study Director Shire
More Information
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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT04057131    
Other Study ID Numbers: SHP667-401
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.
URL: https://vivli.org/ourmember/takeda/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Angioedema
Angioedemas, Hereditary
Hereditary Complement Deficiency Diseases
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Primary Immunodeficiency Diseases
Genetic Diseases, Inborn
Immunologic Deficiency Syndromes
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