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Completed

NCT Number: NCT03047031

Post Marketing Surveillance of Nintedanib in Indian Patients With Idiopathic Pulmonary Fibrosis

This is an active surveillance study to monitor the real world safety of nintedanib in Indian patients with Idiopathic Pulmonary Fibrosis. The safety of nintedanib has been assessed in clinical trials.This active surveillance aims to collect the safety data of 200 IPF patients treated with nintedanib in approved indication after the commercial availability of the drug in India (23rd January 2017). The objective is to look at safety of nintedanib in the real world setting.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asthma Bhawan, Jaipur, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with documented diagnosis of Idiopathic Pulmonary Fibrosis (IPF) based upon ATS/ERS/JRS/ALAT 2011 guidelines (nintedanib naïve or pirfenidone pre-treated) who have initiated or will initiate nintedanib according to the package insert after the commercial availability of drug in India (23rd January 2017).
  • Patients in whom it is possible to obtain voluntary informed consent either from the patient or patient's legally authorised representative (applicable for Group B and C patients).
  • Patients in whom data collection is possible from the medical records (applicable for Group A and B patients)
  • Further inclusion criteria apply

Exclusion criteria

  • Patients who were previously treated with nintedanib.
  • Patients who have initiated or will initiate nintedanib concomitantly with pirfenidone..
  • Patients who are participating in a clinical trial.
  • Further exclusion criteria apply.

Treatment and study plan

Nintedanib

Drug

Nintedanib

pirfenidone

Drug

Pirfenidone

Primary outcomes

  1. Incidence Rate of All ADRs in Nintedanib Treated Patients

    Time frame: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.

    Incidence of all Adverse Drug Reactions (ADRs) in nintedanib treated patients is reported. An adverse reaction is defined as at least a reasonable possibility of a causal relationship between a suspected medicinal product and an adverse event.

    Incidence rate was calculated using the number of patients with ADRs events per treatment divided by time at risk expressed as [100 patient-years (pt-yrs)].

    Time at risk was calculated as below:

    If patients with AE: Time at risk= (start date of first AE- start date of treatment administration) +1; If patients without AE: Time at risk= (end of date at risk (date of study completion or date of discontinuation or last visit date available)-start date of treatment administration) +1.

  2. Incidence Rate of All SAEs in Nintedanib Treated Patients

    Time frame: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.

    Incidence rate of all Serious Adverse Events (SAEs) in nintedanib treated patients is reported.

    A SAE was defined as any adverse event which:

    • results in death,
    • is life-threatening,
    • requires in-patient hospitalization, or
    • prolongation of existing hospitalisation,
    • results in persistent or significant disability or incapacity, or
    • is a congenital anomaly/birth defect.

    Incidence rate was calculated using the number of patients with SAEs events per treatment divided by time at risk expressed as [100 patient-years (pt-yrs)].

    Time at risk was calculated as below:

    If patients with AE: Time at risk= (start date of first AE- start date of treatment administration) +1; If patients without AE: Time at risk= (end of date at risk (date of study completion or date of discontinuation or last visit date available)-start date of treatment administration) +1.

Secondary outcomes

  1. Percentage of Patients With AEs Leading to Permanent Dose Reductions of Study Drug

    Time frame: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.

    Percentage of patients with Adverse Events (AEs) leading to permanent dose reductions of study drug is reported.

  2. Percentage of Patients With AEs Causing Dose Interruption of Study Drug

    Time frame: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.

    Percentage of patients with Adverse Events (AEs) causing dose interruption of study drug is reported.

  3. Percentage of Patients With AEs Leading to Permanently Discontinuation of Study Drug

    Time frame: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.

    Percentage of patients with adverse events (AEs) leading to permanently discontinuation of study drug is reported.

    Percentages are rounded to one decimal places.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

An Active Surveillance to Monitor the Real World Safety in Indian Patients Prescribed Nintedanib for the Treatment of Idiopathic Pulmonary Fibrosis

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Feb 8, 2017
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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