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NCT05676112 Clinical Trial

Safety of Nintedanib in Real World in China

Pulmonary Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT05676112
Other study ID # 1199-0412
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date December 29, 2023
Est. completion date September 30, 2026

Study information
Verified date December 2023
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date September 30, 2026
Est. primary completion date September 30, 2026
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• nintedanib
nintedanib
• pirfenidone
pirfenidone

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Boehringer Ingelheim China-Japan Friendship Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence rate of adverse drug reactions (ADRs) during entire follow-up period During entire follow-up period, up to 1 year
Primary Incidence rate of adverse drug reactions (ADRs) during the 1-year follow-up period after the index date During follow-up period after index date, up to 1 year
Primary Incidence rate of fatal adverse events (AEs) during entire follow-up period During entire follow-up period, up to 1 year
Primary Incidence rate of fatal adverse events (AEs) during the 1-year follow-up period after the index date During follow-up period after index date, up to 1 year
Secondary 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 At baseline
Secondary 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 At baseline
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