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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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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000020722 |
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Date of registration:
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25/01/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Prospective study of efficiency of fibrosis score in computed tomography as predictor after treatment with Nintedanib for idiopathic pulmonary fibrosis
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Scientific title:
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Prospective study of efficiency of fibrosis score in computed tomography as predictor after treatment with Nintedanib for idiopathic pulmonary fibrosis - The CT study with Nintedanib |
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Date of first enrolment:
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2016/01/26 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023054 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not applicable
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Countries of recruitment
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Japan
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Contacts
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Name:
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Hideya Kitamura |
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Address:
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Tomioka-higashi 6-16-1, Kanazawa-ku, Yokohama-city, Japan
Japan |
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Telephone:
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0457019581 |
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Email:
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hideyak5555@gmail.com |
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Affiliation:
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Kanagawa Cardiovascular and Respiratory Center Department of Respiratory Medicine |
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Name:
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Takashi Ogura |
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Address:
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Tomioka-higashi 6-16-1, Kanazawa-ku, Yokohama-city, Japan
Japan |
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Telephone:
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0457019581 |
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Email:
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ogura@kanagawa-junko.jp |
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Affiliation:
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Kanagawa Cardiovascular and Respiratory Center Department of Respiratory Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) AST/ALT/T-bil are is more than reference value 2.5 times 2)Patient who was determined as ineligible by the investigator or the subinvestigator. 3) The patients who has already received corticosteroid (over 10mg/day), immunosupressant, N-acetylcysteine , pirfenidone, and other treatment for IPF 4) Active infection and other severe complication 5) Malignant tumor 6) case was determined as ineligible by attending physician
Age minimum:
40years-old
Age maximum:
Not applicable
Gender:
Male and Female
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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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administration of 150mg of nintedanib twice daily
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Primary Outcome(s)
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the change in fibrosis score of computed tomography over 52-week after treatment with Nintedanib
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Secondary Outcome(s)
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the change in distance and the lowest SpO2 during 6-minute walk test, pulmonary function tests (FVC and diffusing capacity of the lung for carbon monoxide),serum levels of the markers (KL-6 and surfactant protein -D), quality of life, the rate of acute exacerbation, the time to the first acute exacerbation, progression-free survival time and survival time over 52-week after treatment with Nintedanib
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Source(s) of Monetary Support
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No funding
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Ethics review
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Status: YES
Approval date:
Contact:
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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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