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Clinical Trials in Italy / NCT06714812
Active, not recruiting Observational

Diarrheal Adverse Events in Caucasian Patients With Idiopathic Pulmonary Fibrosis Undergoing Treatment With Nintedanib

NCT06714812 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2023-08-20
Last updated
2025-12-19

Condition(s) studied

IPF

Study summary

The goal of this observational study is to identify the demographic and clinical characteristics associated with the development of diarrheal adverse events in a Caucasian population with IPF undergoing treatment with nintedanib. Additionally this study aims to evaluate the different therapeutic strategies for dose reduction of nintedanib and assess the effectiveness of these strategies in reducing the occurrence of diarrhea.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Caucasian ethnicity; * Age ≥ 18 years; * Subjects with a diagnosis of IPF who started antifibrotic therapy with nintedanib on or after 01/06/2020. * Obtaining written informed consent Exclusion Criteria: * clinical and functional data not availbale

Primary outcome measure(s)

  • Identification of the demographic and clinical characteristics associated with the development of diarrheal adverse events in a Caucasian population with IPF undergoing treatment with nintedanib — 18 months
    Presence and intensity of diarrheal adverse events defined according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, which defines diarrhea as 'frequent and watery bowel movements' and classifies it into the following grades: Grade 1 = Increase in the number of daily bowel movements \< 4 compared to baseline. Grade 2 = Increase in the number of daily bowel movements from 4-6 compared to baseline. Grade 3 = Increase in the number of daily bowel movements \> 7 compared to baseline. Grade 4 = Requires urgent intervention, life-threatening. Grade 5 = Death

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliera-Universitaria di Bologna Bologna Bologna

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06714812 on ClinicalTrials.gov ↗ ← All trials in Italy