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

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ClinicalTrials.gov Identifier: NCT03047031
Recruitment Status : Recruiting
First Posted : February 8, 2017
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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.

Condition or disease
Idiopathic Pulmonary Fibrosis

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: An Active Surveillance to Monitor the Real World Safety in Indian Patients Prescribed Nintedanib for the Treatment of Idiopathic Pulmonary Fibrosis
Actual Study Start Date : April 6, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


Group/Cohort
Group A
Patients who started treatment with nintedanib after 23rd January, 2017 and have permanently discontinued the drug (as decided by the investigator) at the time of participation in the active surveillance.
Group B
Patients who started treatment with nintedanib after 23rd January, 2017 and are continuing the drug at the time of participation in the active surveillance.
Group C
Patients who have been newly prescribed nintedanib at the time of participation in the active surveillance



Primary Outcome Measures :
  1. Incidence of all Adverse Drug Reactions (ADRs) in nintedanib treated patients [ Time Frame: up to 56 weeks ]
  2. Incidence of all serious adverse events (SAEs) in nintedanib treated patients [ Time Frame: up to 56 weeks ]

Secondary Outcome Measures :
  1. Percentage of patients who require dose reductions, interruptions and discontinuation due to adverse events [ Time Frame: up to 56 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This active surveillance will include all IPF patients treated with nintedanib per the inclusion/exclusion criteria at selected centres during the first two years after the commercial availability of the drug.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03047031


Contacts
Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
India
St. Johns medical College and Hospital Recruiting
Bangalore, India, 560034
Contact: Priya Ramachandra    9663590386    supriarvind@yahoo.co.in   
National Allergy Asthma Bronchitis Institute, Kolkata Recruiting
Kolkatta, India, 700017
Contact: Alok Gopal Ghoshal    91-9830068023    agghosal@yahoo.com   
Sponsors and Collaborators
Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03047031     History of Changes
Other Study ID Numbers: 1199-0280
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Nintedanib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action