Pulmonary FibrosisNCT05676112
Safety of Nintedanib in Real World in China
An observational study of Pulmonary Fibrosis, run by Boehringer Ingelheim.
Trial summary
The main objective of this study is to evaluate the incidence rates of adverse drug reactions (ADRs) and fatal adverse events (AEs) among idiopathic pulmonary fibrosis (IPF) patients in China who initiate nintedanib during the study period. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Fibrosis
- What is being tested?
- nintedanib and pirfenidone
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 29 Dec 2023to 30 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Idiopathic pulmonary fibrosis (IPF) patients in China: Patients who initiate nintedanib during the study (group 1). The index date for this group of patients is defined as the day when a patient initiates nintedanib; Patients who initiate pirfenidone during the study (group 2). The index date for this group of patients is defined as the day when a patient initiates pirfenidone; Patients who receive neither nintedanib nor pirfenidone (group 3). To define the index date for this group of patients, we will first calculate the average number of days between the first diagnosis of IPF and the day when nintedanib is initiated in group 1 patients (Xn). The index date for group 3 patients is defined as Xn days after the first diagnosis of IPF of a patient.
Who may be able to join
- Patients who initiate nintedanib during the study period
- Patients who initiate pirfenidone during the study period
- Patients who use neither nintedanib nor pirfenidone
- Patients who were diagnosed with IPF according to the 2011 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) guidelines in the past 3 months before recruitment
- Patients who are 40 years old and above when enrolled
- Patients who are willing to participate in the study and sign the informed consent form
Who cannot join
None listed.
About this study
Official title: Safety of Nintedanib in Real World in China: a Non-interventional Study Based on Idiopathic Pulmonary (Interstitial) Fibrosis Registry China Study (PORTRAY) Data
The main objective of this study is to evaluate the incidence rates of adverse drug reactions (ADRs) and fatal adverse events (AEs) among idiopathic pulmonary fibrosis (IPF) patients in China who initiate nintedanib during the study period.
- Conditions
- Pulmonary Fibrosis
- Being tested
- nintedanib, pirfenidone
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nintedanibDrug
nintedanib
pirfenidoneDrug
pirfenidone
| Study group | Role | What they receive |
|---|---|---|
| Nintedanib new users | Not described Receives: Drug: nintedanib | |
| Pirfenidone new users | Not described Receives: Drug: pirfenidone | |
| no drug-treated users | subjects who did not receive nintedanib, pirfenidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of adverse drug reactions (ADRs) during entire follow-up period
Measured: During entire follow-up period, up to 1 year
Incidence rate of adverse drug reactions (ADRs) during the 1-year follow-up period after the index date
Measured: During follow-up period after index date, up to 1 year
Incidence rate of fatal adverse events (AEs) during entire follow-up period
Measured: During entire follow-up period, up to 1 year
Incidence rate of fatal adverse events (AEs) during the 1-year follow-up period after the index date
Measured: During follow-up period after index date, up to 1 year
Secondary outcomes (2)
Mean age at baseline of idiopathic pulmonary disease (IPF) patients in China who are new users of nintedanib, new users of pirfenidone, and those who receive neither of the two antifibrotic drug
Measured: At baseline
Percentage of each gender of idiopathic pulmonary disease (IPF) patients in China who are new users of nintedanib, new users of pirfenidone, and those who receive neither of the two antifibrotic drug
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start29 Dec 2023 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Why it stopped: Company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- China-Japan Friendship Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676112
- Sponsor's protocol ID
- 1199-0412
- Status last verified
- Dec 2024
- First submitted
- 22 Dec 2022
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Nintedanib in Real World in China: a Non-interventional Study Based on Idiopathic Pulmonary (Interstitial) Fibrosis Registry China Study (PORTRAY) Data
- ClinicalTrials.gov ID
- NCT05676112
- Acronym / sponsor ID
- 1199-0412
- Conditions
- Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Company decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- China-Japan Friendship Hospital
- Study start
- 29 Dec 2023 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to evaluate the incidence rates of adverse drug reactions (ADRs) and fatal adverse events (AEs) among idiopathic pulmonary fibrosis (IPF) patients in China who initiate nintedanib during the study period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nintedanib new users | – | Drug: nintedanib |
| Pirfenidone new users | – | Drug: pirfenidone |
| no drug-treated users | – | –subjects who did not receive nintedanib, pirfenidone |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Idiopathic pulmonary fibrosis (IPF) patients in China: Patients who initiate nintedanib during the study (group 1). The index date for this group of patients is defined as the day when a patient initiates nintedanib; Patients who initiate pirfenidone during the study (group 2). The index date for this group of patients is defined as the day when a patient initiates pirfenidone; Patients who receive neither nintedanib nor pirfenidone (group 3). To define the index date for this group of patients, we will first calculate the average number of days between the first diagnosis of IPF and the day when nintedanib is initiated in group 1 patients (Xn). The index date for group 3 patients is defined as Xn days after the first diagnosis of IPF of a patient.
Key inclusion criteria (6 listed)
- Patients who initiate nintedanib during the study period
- Patients who initiate pirfenidone during the study period
- Patients who use neither nintedanib nor pirfenidone
- Patients who were diagnosed with IPF according to the 2011 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) guidelines in the past 3 months before recruitment
- Patients who are 40 years old and above when enrolled
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| nintedanibnintedanib | Drug | Nintedanib new users |
| pirfenidonepirfenidone | Drug | Pirfenidone new users |
Primary outcome
Incidence rate of adverse drug reactions (ADRs) during entire follow-up period
Time frame: During entire follow-up period, up to 1 year
Incidence rate of adverse drug reactions (ADRs) during the 1-year follow-up period after the index date
Time frame: During follow-up period after index date, up to 1 year
Incidence rate of fatal adverse events (AEs) during entire follow-up period
Time frame: During entire follow-up period, up to 1 year
Incidence rate of fatal adverse events (AEs) during the 1-year follow-up period after the index date
Time frame: During follow-up period after index date, up to 1 year
2 secondary outcomes
Mean age at baseline of idiopathic pulmonary disease (IPF) patients in China who are new users of nintedanib, new users of pirfenidone, and those who receive neither of the two antifibrotic drug
Time frame: At baseline
Percentage of each gender of idiopathic pulmonary disease (IPF) patients in China who are new users of nintedanib, new users of pirfenidone, and those who receive neither of the two antifibrotic drug
Time frame: At baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Link to PORTRAY study on clinicaltrials.govLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Fibrosis, run by Boehringer Ingelheim.
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 6 inclusion and 0 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: withdrawn, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 rate of adverse drug reactions (ADRs) during entire follow-up period (time frame: During entire follow-up period, up to 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2024.