| CTRI Number |
CTRI/2013/01/003290 [Registered on: 11/01/2013] Trial Registered Prospectively |
| Last Modified On: |
05/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A long term clinical study to determine safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) |
|
Scientific Title of Study
|
An open-label extension study of long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1199.33, Version 2.0 dated 15 Oct 2012 |
Protocol Number |
| 2011-002766-21 |
EudraCT |
| NCT01619085 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Anand Pendse |
| Designation |
Project Manager - Clinical Operations |
| Affiliation |
Boehringer Ingelheim (India) Pvt. Ltd |
| Address |
1102 11th Floor Hallmark Business Plaza Gurunanak Hospital Road
Near Gurunanak Hospital Bandra East Mumbai
Mumbai
MAHARASHTRA
400 051
India
Mumbai
MAHARASHTRA
400 051
India |
| Phone |
919820563905 |
| Fax |
912226456163 |
| Email |
anand.pendse@boehringer-ingelheim.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Anand Pendse |
| Designation |
Project Manager - Clinical Operations |
| Affiliation |
Boehringer Ingelheim (India) Pvt. Ltd |
| Address |
1102 11th Floor Hallmark Business Plaza Gurunanak Hospital Road
Near Gurunanak Hospital Bandra East Mumbai
Mumbai
MAHARASHTRA
400 051
India
Mumbai
MAHARASHTRA
400 051
India |
| Phone |
919820563905 |
| Fax |
912226456163 |
| Email |
anand.pendse@boehringer-ingelheim.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Partha Gokhale |
| Designation |
Head Clinical Operations, India |
| Affiliation |
Boehringer Ingelheim India Pvt. Ltd. |
| Address |
Boehringer Ingelheim India Pvt. Ltd. 1102, 11th Floor, Hallmark
Business Plaza, Guru Nanak Hospital Road, Near Guru Nanak
Hospital , Bandra (East)
Mumbai
MAHARASHTRA
400051
India
Mumbai (Suburban)
MAHARASHTRA
400051
India |
| Phone |
91912226456478 |
| Fax |
912226456163 |
| Email |
partha.gokhale@boehringer-ingelheim.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Boehringer Ingelheim |
| Address |
Binger Street 173, Ingelheim, Germany |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Australia
Belgium
Canada
Chile
China
Czech Republic
Finland
France
Germany
Greece
India
Ireland
Israel
Italy
Japan
Mexico
Netherlands
Portugal
Republic of Korea
Russian Federation
Spain
Turkey
United Kingdom
United States of America |
|
Sites of Study
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashish Kumar |
Asthma Bhawan |
Indian Asthma Care Society
R 3 Sector 6
Vidyadhar Nagar
Jaipur
RAJASTHAN |
911412235005
drashish19@gmail.com |
| Dr Sathish Kadappa Shivappa |
Chest And Maternity Centre |
No 878
5th Block
Rajajinagar
Bangalore
KARNATAKA |
919886495731
mamthasatish@gmail.com |
| Dr Mahendra Kawedia |
Jehangir Clinical Development Centre Pvt Ltd |
Jehangir Hospital Premises
32 Sassoon Road
Pune
MAHARASHTRA |
912026059318
mkawedia@gmail.com |
| Dr Parag Khatavkar |
K E M Hospital |
KEM Hospital
Department of Medicine
Chest Unit
Sardar Moodliar Road
Pune
MAHARASHTRA |
919890141514
drpgkhatavkar@gmail.com |
| Dr Parthiv Mehta |
Mehta Hospital and Cardiopulmonary Care Center |
2 floor,
Sidhhachal Complex
Near Doordarshan Kendra,
Drive in Road,
Thaltej
Ahmadabad
GUJARAT |
919825031615
parthiv.mhrc@gmail.com |
| Dr Aloke Gopal Ghosal |
National Allergy Asthma |
Respiratory
Department,
11/3,Dr.Biresh Guha
street,
Kolkata
WEST BENGAL
Kolkata
WEST BENGAL |
919830068023
agghosal@yahoo.com |
| Dr Zarir Udwadia |
P.D Hinduja National Hospital & Medical Research Centre |
Department of Pulmonary Medicine
3rd floor
OPD building
Veer Savarkar Marg
Mahim
Mumbai 400116
Mumbai
MAHARASHTRA |
912224447353
912224447361
zfu@hindujahospital.com |
| Dr K Srikanth |
PSG Hospital |
PSG Hospital,
Respiratory
Department,
Peelamedu, IN
Coimbatore
TAMIL NADU |
914222570170
drsrikanthcbe@gmail.com |
| Dr Virendra Singh |
SMS Medical College |
Division of allergy &
pulmonology,
Dhanvantari OPD block
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
919414051212
drvirendrasingh@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Clinical Research Ethics committe |
Approved |
| Ethics Committee of KEM Hospital Research Centre Pune |
Submittted/Under Review |
| Ethics Committee of SMS Medical College |
Submittted/Under Review |
| Institutional Ethics Committee National Allergy Asthma |
Approved |
| Jehangir Clinical Development Centre (IRB) |
Approved |
| MEDISYS CLINISEARCH ETHICAL REVIEW BOARD. |
Approved |
| PSG Institute of Medical Sciences and Research Institutional Human Ethics Committee |
Submittted/Under Review |
| Safe Research Independent Ethics Committee, Ahmedabad, Dr. Parthiv Mehta |
Approved |
| Swasthya Kalyan Ethics Committee, Jaipur, Dr. Ashish Kumar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Idiopathic Pulmonary Fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nintedanib (BIBF1120) |
Capsules containing BIBF 1120 twice a day.
Dose:- 100mg or 150 mg
Route:- Oral
Frequency:- Twice a day
Duration of therapy;- approximately 6 years |
| Comparator Agent |
None (Open label extension study) |
None (Open label extension study) |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Signed Informed Consent consistent with ICH-GCP and local laws prior to trial
participation
Patients from trials 1199.32 or 1199.34 who completed the 52 weeks treatment period
and performed the follow-up visit |
|
| ExclusionCriteria |
| Details |
AST ALT more than 1.5 fold ULN
Patients who completed the parent trial with transaminase values more than 1.5 fold ULN but less than 3 fold ULN are considered eligible
Bilirubin more than 1.5 fold ULN
Bleeding risk
Patients who require fibrinolysis full dose therapeutic anticoagulation eg
vitamin K antagonists dabigatran heparin hirudin or high dose antiplatelet
therapy Exceptions prophylactic low dose heparin or heparin flush as needed
for maintenance of an indwelling intravenous device eg enoxaparin 4000 IU
sc per day) and prophylactic use of antiplatelet therapy eg acetyl salicylic
acid up to 325 mg per dayor clopidogrel at 75 mg per day or equivalent doses of other
antiplatelet therapy
Hemorrhagic CNS event gross frank haemoptysis or haematuria active
gastrointestinal bleeding or ulcers after completion of the parent trial
Coagulation parameters International normalised ratio INR more than 2 prothrombin
time PT and partial thromboplastin time PTT more than 150percent of institutional ULN
Planned major surgery within the next 3 months including lung transplantation major
abdominal or major intestinal surgery
New major thromboembolic events developed after completion of the parent trial
Stroke
Deep vein thrombosis
Pulmonary embolism
Myocardial infarction
Time period more than 12 weeks between Visit 9 of the parent trial and Visit 2 of this study
Usage of any investigational drug after completion of the parent trial or planned usage
of a specific investigational drug during the course of this trial
A disease or condition which in the opinion of investigator may put the patient at risk
because of participation in this trial or limit the patients ability to participate in this
trial
Alcohol or drug abuse which in the opinion of the investigator would interfere with
trial participation
Pregnant women or women who are breast feeding or of child bearing potential not
using two effective methods of birth control one barrier and one highly effective nonbarrier
for at least 1 month prior to Visit 2 and or not committing to using it until 3
months after end of treatment
Women will be considered to be of childbearing potential unless surgically sterilised
by hysterectomy or bilateral tubal ligation or postmenopausal for at least two years
Highly effective methods of birth control include established use of oral injected or
implanted hormonal methods of contraception placement of an intrauterine device
IUD or intrauterine system IUS A barrier method of contraception includes
condom or occlusive cap with spermicidal foam gel film cream suppository or
male sterilization with appropriate postvasectomy documentation of the absence of
sperm in the ejaculate
Sexually active men not committing to using condoms during participation in the
study except if their partner is not of childbearing potential and 3 months after the
last intake of BIBF 1120 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the long-term safety of BIBF 1120
treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one
year treatment and the follow-up period in the phase III trials 1199.32 and 1199.34 |
To assess the long-term safety (up to approximately 6 years) of BIBF 1120
treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one
year treatment and the follow-up period in the phase III trials 1199.32 and 1199.34 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="759"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/01/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
02/07/2012 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="6"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) . The total number of patients proposed to be recruited in India is 20. First patient is expected to be rolled-over on 31 Jan 2013. |