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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03047031
Recruitment Status : Completed
First Posted : February 8, 2017
Last Update Posted : August 23, 2022
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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 Design
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Study Type : Observational
Actual Enrollment : 21 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 5, 2017
Actual Primary Completion Date : July 21, 2022
Actual Study Completion Date : July 21, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Nintedanib

Groups and Cohorts
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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.
Contacts and Locations
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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


Locations
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India
Gleneagles Global Hospital
Chennai, India, 600100
Sri Ramakrishna Hospital
Coimbatore, India, 641044
Asthma Bhawan
Jaipur, India, 302039
CK Birla Hospitals, The Calcutta Medical Research Institute
Kolkata, India, 700027
National Allergy Asthma Bronchitis Institute, Kolkata
Kolkatta, India, 700017
King George Medical University
Lucknow, India, 226003
Midland Healthcare and Research Centre
Lucknow, India, 226006
Bhatia Hospital
Mumbai, India, 400007
P.D. Hinduja National Hospital
Mumbai, India, 400016
Grant Medical Foundation, Ruby Hall Clinic
Pune, India, 411001
Sponsors and Collaborators
Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03047031    
Other Study ID Numbers: 1199-0280
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: August 23, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
URL: https://www.mystudywindow.com/msw/datasharing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
 Pathologic Processes
Lung Diseases
Respiratory Tract Diseases