Safety of Nintedanib in Real World in China

NCT05676112 | Withdrawn

• 1 other identifier: 1199-0412
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (4)

• Incidence rate of adverse drug reactions (ADRs) during entire follow-up period

  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

  During follow-up period after index date, up to 1 year

• Incidence rate of fatal adverse events (AEs) during entire follow-up period

  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

  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

  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

  At baseline

Study Arms (3)

Nintedanib new users

Drug: nintedanib

Pirfenidone new users

Drug: pirfenidone

no drug-treated users

subjects who did not receive nintedanib, pirfenidone

Interventions

nintedanib DRUG

nintedanib

Nintedanib new users

pirfenidone DRUG

pirfenidone

Pirfenidone new users

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• China-Japan Friendship Hospital: collaborator

Related Links

• Link to PORTRAY study on clinicaltrials.gov

MeSH Terms

Conditions

Pulmonary Fibrosis

Interventions

nintedanib; pirfenidone

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 9, 2023
• Study Start: December 29, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share