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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02699879 |
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Date of registration:
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26/02/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of Long-Term Safety of Pirfenidone (Esbriet) in Participants With Idiopathic Pulmonary Fibrosis (IPF)
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Scientific title:
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Post-Authorisation Safety Study of Esbriet® (Pirfenidone): A Prospective Observational Registry to Evaluate Long-Term Safety in a Real-World Setting |
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Date of first enrolment:
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February 16, 2012 |
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Target sample size:
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1009 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02699879 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Austria
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Denmark
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Finland
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France
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Germany
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Ireland
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Italy
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Norway
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Sweden
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United Kingdom
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- A clinical decision has been made, prior to study enrolment, to prescribe Esbriet
- Participants who are newly prescribed Esbriet therapy
- Initiation of Esbriet therapy is not more than 30 days prior to study enrolment
Exclusion Criteria:
- Participants receiving an investigational agent defined as any drug that has not been
approved for marketing for any indication in the country of the participating site
- Participant has received Esbriet therapy 30 days or more prior to current treatment
course (e.g., prior participation in clinical trials)
- Participant has any contraindication for the use of Esbriet, according to the current
local version of the Summary of Product Characteristics (SPC)
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Idiopathic Pulmonary Fibrosis
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Intervention(s)
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Drug: Pirfenidone
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Primary Outcome(s)
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Percentage of participants with clinically significant ADRs of special interest
[Time Frame: up to 2 years]
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Percentage of participants with adverse drug reactions (ADRs) and serious adverse drug reactions
[Time Frame: up to 2 years]
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Secondary ID(s)
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WB29908
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PIPF-025
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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