UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036457 |
|---|---|
| Receipt number | 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 | 2023/04/12 21:39:01 |
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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
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
mthrsgnm@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital, Respiratory medicine
Institute
Department
Personal name
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
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
Completed
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
| 2023 | 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
| 2023 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041548
