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Safety of Nintedanib in Real World in China

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05676112
Collaborator
China-Japan Friendship Hospital (Other)
800
Enrollment
1
Location
42.5
Anticipated Duration (Months)
18.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
800 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Mar 15, 2023
Anticipated Primary Completion Date :
Sep 30, 2026
Anticipated Study Completion Date :
Sep 30, 2026

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Incidence rate of adverse drug reactions (ADRs) during entire follow-up period [During entire follow-up period, up to 1 year]

  2. 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]

  3. Incidence rate of fatal adverse events (AEs) during entire follow-up period [During entire follow-up period, up to 1 year]

  4. 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

  1. 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]

  2. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 China-Japan Friendship Hospital Beijing China 100029

Sponsors and Collaborators

  • Boehringer Ingelheim
  • China-Japan Friendship Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT05676112
Other Study ID Numbers:
  • 1199-0412
First Posted:
Jan 9, 2023
Last Update Posted:
Jan 27, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Pulmonary Fibrosis
Fibrosis
Pirfenidone
Nintedanib

Study Results

No Results Posted as of Jan 27, 2023