Safety of Nintedanib in Real World in China

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.

Study Overview

• Status: Withdrawn
• Conditions: Pulmonary Fibrosis
• Intervention / Treatment: Drug: nintedanib; Drug: pirfenidone

• Study Type: Observational

Contacts and Locations

• Study Contact: Name: Boehringer Ingelheim; Phone Number: 1-800-243-0127; Email: clintriage.rdg@boehringer-ingelheim.com

Study Locations

• China
  • Beijing, China, 100029
    • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Nintedanib new users	Drug: nintedanib; nintedanib
Pirfenidone new users	Drug: pirfenidone; pirfenidone
no drug-treated users; subjects who did not receive nintedanib, pirfenidone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Collaborators: China-Japan Friendship Hospital

Publications and helpful links

Helpful Links

• Link to PORTRAY study on clinicaltrials.gov

Study record dates

Study Major Dates

• Study Start (Estimated): December 29, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: December 22, 2022
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pulmonary Fibrosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Protein Kinase Inhibitors; Pirfenidone; Nintedanib
• Other Study ID Numbers: 1199-0412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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