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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 10, 2021
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

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Study Type : Observational
Estimated Enrollment : 400 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
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022


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

Locations
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India
Sterling Hospital Recruiting
Ahmedabad, India, 380015
Contact: Tushar Patel    91 79 40011622    drtusharpatel@yahoo.com   
St. Johns medical College and Hospital Recruiting
Bangalore, India, 560034
Contact: Priya Ramachandra    9663590386    supriarvind@yahoo.co.in   
Gleneagles Global Hospital Recruiting
Chennai, India, 600100
Contact: Vijil Rahulan    +91-044-44777000    vkrahulan@gmail.com   
Sri Ramakrishna Hospital Recruiting
Coimbatore, India, 641044
Contact: T. Mohankumar    91 9894622018    tmkdr@hotmail.com   
Artemis Health Institute Recruiting
Gurgaon, India, 122001
Contact: ASHOK RAJPUT    91 124 4511 111    ashok.rajput@artemishospitals.com   
Asthma Bhawan Recruiting
Jaipur, India, 302039
Contact: Virendra Singh    91 9414051212    drvirendrasingh93@gmail.com   
National Allergy Asthma Bronchitis Institute, Kolkata Recruiting
Kolkatta, India, 700017
Contact: Alok Gopal Ghoshal    91-9830068023    agghosal@yahoo.com   
King George Medical University Recruiting
Lucknow, India, 226003
Contact: Surya Kant    +91-5222255167    skantpulmed@gmail.com   
Midland Healthcare and Research Centre Recruiting
Lucknow, India, 226006
Contact: Bhanu Singh    0522-2333333    bps2159@yahoo.com   
Bhatia Hospital Recruiting
Mumbai, India, 400007
Contact: Sujeet Rajan    91-9820191302    skrajan@hotmail.com   
P.D. Hinduja National Hospital Recruiting
Mumbai, India, 400016
Contact: Zarir Udwadia    22-24447353    zfu@hindujahospital.com   
Ketki Research Institute of Medical Sciences(KRIMS) Hospital Recruiting
Nagpur, India, 440010
Contact: Ashok Arbat    +91-9822466640    ashok_arbat@yahoo.com   
Getwell Hospital & Research Institute Recruiting
Nagpur, India, 440012
Contact: Rajesh Nathuram Swarnakar    91 9314249227    drrajeshswarnakar@gmail.com   
Metro Multispeciality Hospital Recruiting
Noida, India, 201301
Contact: Deepak Talwar    91-120-2533481    dtlung@hotmail.com   
Grant Medical Foundation, Ruby Hall Clinic Recruiting
Pune, India, 411001
Contact: Mahavir Modi    +91-9822253596    drm_modi@yahoo.co.in   
Sponsors and Collaborators
Boehringer Ingelheim
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: September 10, 2021
Last Verified: September 2021
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