Lung Diseases, InterstitialNCT04559581

Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan

An observational study of Lung Diseases, Interstitial, run by Boehringer Ingelheim at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective is to evaluate the incidence of adverse drug reactions (focus on hepatic function disorders) of Ofev Capsules under the real world setting in patients with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype (PF-ILD). Read more about this study

Who is it for?: Any age
Conditions the study is for: Lung Diseases, Interstitial
What is being tested?: Nintedanib
Type of treatment: Pill or oral medicine
How many people: 425 participants
Where: 1 siteJapan
Study dates: 2 Oct 2020to 22 Jan 2025
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Non-interventional study in patients in Japan with chronic fibrosing ILDs with the progressive phenotype who are prescribed with Ofev and have never been treated with Ofev before; except patients with a diagnosis of idiopathic pulmonary fibrosis or patients with other chronic fibrosing ILDs with the progressive phenotype due to systemic sclerosis as the underlying disease. No limitations are set up on background factors and their concomitant drugs in use of actual medical practice.

Who may be able to join

Patients in Japan with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype who are prescribed with Ofev Capsules and have never been treated with Ofev Capsules before enrolment will be included.

Who cannot join

Diagnosis of Idiopathic Pulmonary Fibrosis
Patients with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype due to systemic scleroderma as the underlying disease

Trial locations and contacts

1 site in 1 country.

Japan1 site

Nippon Boehringer Ingelheim Co., Ltd.
Tokyo, 1416017

Other trials in Japan

About this study

Conditions: Lung Diseases, Interstitial
Being tested: Nintedanib
Medical subject headings: Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NintedanibDrug
Also called Ofev
Ofev Capsules as prescribed by the treating physician

Study groups in NCT04559581
Study group	Role	What they receive
Ofev Capsules		Patients in Japan with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who were prescribed with Ofev Capsules and were never treated with Ofev Capsules before enrolment, were followed for up to 104 weeks or until discontinuation of administration. The enrollment took place from October 2020 to September 2022. Receives: Drug: Nintedanib

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Adverse Drug Reactions (ADRs)
Incidence of adverse drug reactions (ADRs) is reported as the number of participants with an ADR. An adverse event (AE) was considered to be an ADR if either the physician who reported the AE, or the sponsor, assessed its causal relationship as 'related'.
Measured: From first intake of Ofev Capsules prescribed at baseline visit and within 28 days (inclusive) after the last intake of Ofev Capsules, up to approximately 204 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Oct 202022 Jan 2025

First posted23 Sep 2020
Study start2 Oct 2020
Primary completion18 Dec 2024
Study completion22 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lung Diseases, InterstitialStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 425 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04559581
Sponsor's protocol ID: 1199-0402
Other IDs: EUPAS36605
Status last verified: Nov 2025
First submitted: 17 Sep 2020
Last updated: 6 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Publications

Ito T, Shibuya A, Noguchi H. Safety and Tolerability of Nintedanib in Japanese Patients with Progressive Fibrosing Interstitial Lung Diseases: Final Results of 2-Year Post-Marketing Surveillance. Adv Ther. 2026 Apr;43(4):1723-1740. doi: 10.1007/s12325-026-03502-w. Epub 2026 Feb 20.
PubMed 41718945

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lung Diseases, Interstitial trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan
ClinicalTrials.gov ID: NCT04559581
Acronym / sponsor ID: 1199-0402
Conditions: Lung Diseases, Interstitial
Study type: Observational
Recruitment status: Completed
Enrolment: 425 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 2 Oct 2020 (actual)
Primary completion: 18 Dec 2024 (actual)
Study completion: 22 Jan 2025 (actual)
First posted: 23 Sep 2020 (actual)
Results: Posted 6 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Ofev Capsules	–	Drug: NintedanibPatients in Japan with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who were prescribed with Ofev Capsules and were never treated with Ofev Capsules before enrolment, were followed for up to 104 weeks or until discontinuation of administration. The enrollment took place from October 2020 to September 2022.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Non-interventional study in patients in Japan with chronic fibrosing ILDs with the progressive phenotype who are prescribed with Ofev and have never been treated with Ofev before; except patients with a diagnosis of idiopathic pulmonary fibrosis or patients with other chronic fibrosing ILDs with the progressive phenotype due to systemic sclerosis as the underlying disease. No limitations are set up on background factors and their concomitant drugs in use of actual medical practice.

Key inclusion criteria (1 listed)

Patients in Japan with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype who are prescribed with Ofev Capsules and have never been treated with Ofev Capsules before enrolment will be included.

Key exclusion criteria (2 listed)

Diagnosis of Idiopathic Pulmonary Fibrosis
Patients with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype due to systemic scleroderma as the underlying disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NintedanibAlso: OfevOfev Capsules as prescribed by the treating physician	Drug	Ofev Capsules

Primary outcome

Incidence of Adverse Drug Reactions (ADRs)
Time frame: From first intake of Ofev Capsules prescribed at baseline visit and within 28 days (inclusive) after the last intake of Ofev Capsules, up to approximately 204 weeks.
Incidence of adverse drug reactions (ADRs) is reported as the number of participants with an ADR. An adverse event (AE) was considered to be an ADR if either the physician who reported the AE, or the sponsor, assessed its causal relationship as 'related'.

Results and safety

Results posted to the registry on 6 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ofev Capsules	408	165

Primary outcome: Incidence of Adverse Drug Reactions (ADRs)

Time frame: From first intake of Ofev Capsules prescribed at baseline visit and within 28 days (inclusive) after the last intake of Ofev Capsules, up to approximately 204 weeks.. Count of participants. Unit: Participants

Measure	Ofev Capsules n = 408
Value	246

Population analysed: Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.

Adverse events

Group	Serious adverse events	Other adverse events	Deaths
Ofev Capsules	139 of 408 (34.1%)	192 of 408 (47.1%)	59 of 408

Limitations and caveats (from the sponsor): Due to the nature of a single cohort observational study, there are issues that may impose limitations, in particular on the validity of the assessment based on the study data, such as selection bias, loss to follow up, channeling bias, and information and recall bias. Thus, comparisons and causal conclusions cannot be made, except for the investigator reported drug-related adverse events.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41718945Ito T, Shibuya A, Noguchi H. Safety and Tolerability of Nintedanib in Japanese Patients with Progressive Fibrosing Interstitial Lung Diseases: Final Results of 2-Year Post-Marketing Surveillance. Adv Ther. 2026 Apr;43(4):1723-1740. doi: 10.1007/s12325-026-03502-w. Epub 2026 Feb 20.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Related trials for Lung Diseases, Interstitial

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Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Diseases, Interstitial, run by Boehringer Ingelheim at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Drug Reactions (ADRs) (time frame: From first intake of Ofev Capsules prescribed at baseline visit and within 28 days (inclusive) after the last intake of Ofev Capsules, up to approximately 204 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04559581, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.