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Trial record 3 of 23 for:    ICATIBANT

FIRAZYR General Drug Use-Results Survey (Japan)

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

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

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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


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




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.



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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


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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Japan
Nagoya-city Recruiting
Nagoya, Aichi, Japan, 453-0046
Toyohashi-city Recruiting
Toyohashi, Aichi, Japan, 441-8570
Maebashi-city Recruiting
Maebashi, Gunma, Japan, 371-8511
Asahikawa-city Recruiting
Asahikawa, Hokkaido, Japan, 070-0034
Fukagawa-city Recruiting
Fukagawa, Hokkaido, Japan, 074-0006
Rumoi-city Recruiting
Rumoi, Hokkaido, Japan, 077-0011
Sapporo-city Recruiting
Sapporo, Hokkaido, Japan, 002-8072
Kasama-city Recruiting
Kasama, Ibaraki, Japan, 309-1703
Maizuru-city Recruiting
Maizuru, Kyoto, Japan, 625-8585
Kishiwada-city Recruiting
Kishiwada, Osaka, Japan, 596-0042
Takatsuki-city Recruiting
Takatsuki, Osaka, Japan, 569-0096
Kawagoe-city Recruiting
Kawagoe, Saitama, Japan, 350-8550
Soka-city Recruiting
Soka, Saitama, Japan, 340-0041
Numazu-city Recruiting
Numazu, Shizuoka, Japan, 410-0302
Shimada-city Recruiting
Shimada, Shizuoka, Japan, 427-8502
Yaezu-city Recruiting
Yaezu, Shizuoka, Japan, 425-0088
Tachikawa-city Recruiting
Tachikawa, Tokyo, Japan, 190-0014
Niigata-city Recruiting
Niigata, Japan, 950-1197
Sponsors and Collaborators
Shire
Investigators
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Study Director: Study Director Shire

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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT04057131     History of Changes
Other Study ID Numbers: SHP667-401
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Shire provides access to the de-identified individual participant data for eligible studies to aid qualified researchers in addressing legitimate scientific objectives. These IPDs will be provided 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 in the Data Sharing section of the www.shiretrials.com website. 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://www.shiretrials.com/en/our-commitment-to-transparency/data-sharing-with-researchers

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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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Icatibant
Angioedema
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Genetic Diseases, Inborn
Bradykinin
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
Vasodilator Agents