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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036457
Receipt No. R000041548
Scientific Title Exploratory study of blood biomarkers to predict the therapeutic effect of nintedanib in idiopathic pulmonary fibrosis (IPF)
Date of disclosure of the study information 2019/05/01
Last modified on 2019/04/09

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Basic information
Public title Exploratory study of blood biomarkers to predict the therapeutic effect of nintedanib in idiopathic pulmonary fibrosis (IPF)
Acronym OFBIO study
Scientific Title Exploratory study of blood biomarkers to predict the therapeutic effect of nintedanib in idiopathic pulmonary fibrosis (IPF)
Scientific Title:Acronym OFBIO study
Region
Japan

Condition
Condition idiopathic pulmonary fibrosis (IPF)
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to search for factors that predict the therapeutic effect of nintedanib using serum and plasma samples of idiopathic pulmonary fibrosis patients who receive nintedanib.
Basic objectives2 Others
Basic objectives -Others If biomarkers that predict the therapeutic effect of IPF are found, it may be possible to forgo patients with poor therapeutic efficacy. Since antifibrotic drugs cause side effects relatively frequently, they can avoid the side effects that appear in patients who do not benefit from antifibrotic drugs, which is considered to lead to the realization of personalized medicine.
Furthermore, the biomarkers found in this study are not only biomarkers that predict the therapeutic effects of antifibrotic drugs, but also likely to be biomarkers that predict the prognosis of IPF, and contribute to research and development of the disease itself.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Decrease of % FVC
Key secondary outcomes Symptoms
Treatment continuation rate
Overall survival
Adverse event

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1 Patients diagnosed with IPF according to 2018 ATS / ERS / JRS / ALAT guidelines
2 Patients over 20 years old
3 Patients with %FVC less than 80% at entry time or patients with decrease of %FVC more than 3% in the past 6 months
Key exclusion criteria 1 Patients who can not get consent
2 patients whom the doctor in charge deems inappropriate
3 Patients with acute exacerbation at time
4 Patients with malignancy
5 Patients scheduled for surgery within 6 months
6 Patients with severe liver disorder (Child-Pugh B or more)
7 Patients whose prognosis is predicted to be less than 6 months
Target sample size 100

Research contact person
Name of lead principal investigator
1st name MITSUHIRO
Middle name
Last name ABE
Organization Chiba University Hospital
Division name Respiratory medicine
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba, Japan.
TEL 043-226-2576
Email mthrsgnm@chiba-u.jp

Public contact
Name of contact person
1st name MITSUHIRO
Middle name
Last name ABE
Organization Chiba University Hospital
Division name Respiratory medicine
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba, Japan.
TEL 043-226-2576
Homepage URL
Email mthrsgnm@chiba-u.jp

Sponsor
Institute Chiba University Hospital, Respiratory medicine
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor National Institute of Health Sciences
Name of secondary funder(s)

IRB Contact (For public release)
Organization Chiba University
Address 1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba, Japan.
Tel 043-222-7171
Email igaku-koho@chiba-u.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 千葉大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2019 Year 02 Month 01 Day
Date of IRB
2019 Year 02 Month 01 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Perform a statistical analysis for biomarker changes before and after treatment with the Wilcoxon test.
As a secondary study, we will also examine factors affecting symptoms, pulmonary function and HRCT findings at 12 months. Prognostic factors are also examined from the final outcome and survival time.

Management information
Registered date
2019 Year 04 Month 09 Day
Last modified on
2019 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041548

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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