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Safety of Nintedanib in Real World in China

NCT ID: NCT05676112

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-29

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Nintedanib new users

nintedanib

Intervention Type DRUG

nintedanib

Pirfenidone new users

pirfenidone

Intervention Type DRUG

pirfenidone

no drug-treated users

subjects who did not receive nintedanib, pirfenidone

No interventions assigned to this group

Interventions

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nintedanib

nintedanib

Intervention Type DRUG

pirfenidone

pirfenidone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Countries

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China

Related Links

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https://clinicaltrials.gov/ct2/show/NCT03666234?term=NCT03666234&draw=2&rank=1

Link to PORTRAY study on clinicaltrials.gov

Other Identifiers

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1199-0412

Identifier Type: -

Identifier Source: org_study_id