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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name