| CTRI Number |
CTRI/2017/02/007867 [Registered on: 14/02/2017] Trial Registered Prospectively |
| Last Modified On: |
23/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
An active surveillance to monitor the real world safety of Nintedanib in Indian Idiopathic Pulmonary Fibrosis (a type of lung disease in which tissue deep in our lungs becomes thick and stiff, or scarred, over the time) patients |
|
Scientific Title of Study
|
An active surveillance to monitor the real world safety in Indian patients prescribed nintedanib for the treatment of Idiopathic Pulmonary Fibrosis |
| Trial Acronym |
PASS IPF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1199.280: Version 1.0 dated 26-Apr-2016 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Pavitra Wagh |
| Designation |
Manager - Local Clinical Trials |
| Affiliation |
|
| Address |
Boehringer Ingelheim India Pvt. Ltd. 1102, Hallmark Business Plaza, Gurunanak Hospital Road
Bandra (E)
Mumbai (Suburban)
MAHARASHTRA
400051
India |
| Phone |
9967088793 |
| Fax |
|
| Email |
pavitra.wagh@boehringer-ingelheim.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Naik |
| Designation |
Head of Medical Oncology |
| Affiliation |
Boehringer Ingelheim India Pvt Ltd |
| Address |
10th Floor, Hallmark Business Plaza
Gurunanak Hospital Road, Bandra (E), Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
912271456633 |
| Fax |
|
| Email |
rajesh.naik@boehringer-ingelheim.com |
|
Details of Contact Person
Public Query
|
| Name |
Raj Kumar |
| Designation |
Project Manager |
| Affiliation |
Boehringer Ingelheim India Pvt Ltd |
| Address |
11th Floor, Hallmark Business Plaza
Gurunanak Hospital Road, Bandra (E), Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
912271456610 |
| Fax |
|
| Email |
raj.kumar@boehringer-ingelheim.com |
|
|
Source of Monetary or Material Support
|
| Boehringer Ingelheim India Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Boehringer Ingelheim India Pvt Ltd |
| Address |
1102, 11th Floor, Hallmark Business Plaza
Gurunanak Hospital Road, Bandra (E), Mumbai - 400051 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aloke Ghoshal |
National Allergy Asthma Bronchitis Institute |
11/3 Dr Biresh Guha street, 2nd Floor, IMA House, Park Circus, Kolkata
Kolkata
WEST BENGAL |
03322902305
agghosal@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 16 |
| Name of Committee |
Approval Status |
| Artemis Health Sciences Institutional Ethics Committee |
Approved |
| Bhatia Hospital Medical Research Society Ethics Committee |
Approved |
| Getwell Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee Asthma Bhawan |
Approved |
| Institutional Ethics Committee CMRI |
Approved |
| Institutional Ethics Committee for Midland Healthcare & Research Centre |
Approved |
| Institutional Ethics Committee Global Hospitals and Health City |
Approved |
| Institutional Ethics Committee St John’s Medical College and Hospital |
Approved |
| Institutional Ethics Committee, King Georges Medical University |
Approved |
| Institutional Ethics Committee, National Allergy Asthma Bronchitis Institute, Kolkata |
Approved |
| Institutional Ethics Committee, PD Hinduja |
Approved |
| KRIMS Ethics Committee |
Approved |
| Metro Ethical Review Board |
Approved |
| Poona Medical Research Foundation InstitutionalEthicsCommittee |
Approved |
| Sri Ramakrishna Hospital Ethical Committee |
Approved |
| Sterling Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
| Status |
| No Objection Certificate |
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Idiopathic Pulmonary Fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nintedanib |
This is not interventional study. This is an active surveillance is based on new data collection to gather real world information i e
data under routine medical practice on safety of the nintedanib treatment in IPF patients.
In addition consecutive IPF
patients who will be newly prescribed pirfenidone will also be registered.
The number of the patients enrolled in pirfenidone arm
will be equal to the number of patients in the nintedanib arm.
Niintedanib is Soft Gelatin Capsules should be taken orally
Treatment with nintedanib should be initiated by physicians experienced in the diagnosis and treatment of IPF. The recommended dose of nintedanib is 150 mg twice daily administered approximately 12 hours apart |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with documented diagnosis of IPF based upon ATS ERS JRS ALAT 2011 guidelines
and who comply with inclusion and exclusion criteria will be included in this active
surveillance The diagnosis of IPF as per ATS ERS JRS ALAT 2011 guidelines requires
Exclusion of other known causes of ILD eg domestic and occupational environmental
exposures connective tissue disease and drug toxicity
The presence of a UIP pattern on HRCT in patients not subjected to surgical lung biopsy
Specific combinations of HRCT and surgical lung biopsy pattern in patients subjected to
surgical lung biopsy
Patients with IPF IPFtreatment naïve or pretreated who are newly prescribed nintedanib according to the package insert
Willing and able to provide the informed consent
Patients in whom further visit/contact is possible during the planned period of active
surveillance
In addition equal number of consecutive IPF patients with documented diagnosis of IPF
based upon ATS ERS JRS ALAT 2011 guidelines who will be newly prescribed pirfenidone
will be enrolled
Patients with IPF IPF treatment naïve or pretreated who are newly prescribed
pirfenidone
Willing and able to provide informed consent to collect the baseline characteristics |
|
| ExclusionCriteria |
| Details |
Patients who have taken nintedanib before participation in this active surveillance
Patients who are being treated with pirfenidone
Patients who are participating in a clinical trial or other IPF registries
In addition equal number of consecutive IPF patients with documented diagnosis of IPF
based upon ATS ERS JRS ALAT 2011 guidelines who will be newly prescribed pirfenidone
will be enrolled
Patients who have taken pirfenidone before participation in this active surveillance
Patients who are participating in a clinical trial or other IPF registries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Occurrence of ADRs serious and nonserious
Occurrence of AEs serious and fatal |
2 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage of patients who require dose reductions and discontinuation due to adverse
events |
2 years |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "21"
Final Enrollment numbers achieved (India)="21" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/02/2017 |
| Date of Study Completion (India) |
21/07/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This active surveillance is based on new data collection to gather real-world information i e data under routine medical practice) on safety of the nintedanib treatment in IPF patients in Indian real world setting. It will include all IPF patients who have been newly prescribed nintedanib according to the approved Indian label during the first two years from the date of commercial availability of the drug. In addition consecutive IPF patients who will be newly prescribed pirfenidone will also be registered from the same centres during the same time period. The number of the patients enrolled in pirfenidone arm will be equal to the number of patients in the nintedanib arm
|