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CTRI Number  CTRI/2011/12/002245 [Registered on: 16/12/2011] Trial Registered Prospectively
Last Modified On: 03/09/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological
Preventive 
Study Design  Other 
Public Title of Study   A clinical trial to study the safety and efficacy of BIBF 1120 at high dose in patients with lung fibrosis because of unknown cause 
Scientific Title of Study   A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF) 
Trial Acronym  IPF 
Secondary IDs if Any  
Secondary ID  Identifier 
1199.34  Protocol Number 
2010-024252-29  EudraCT 
NCT01335477  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjay Hake 
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
MAHARASHTRA
400 051
India 
Phone  02226456484  
Fax  02226456163  
Email  sanjay.hake@boehringer-ingelheim.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay Hake 
Designation  Project Manager- Clinical Operations  
Affiliation   
Address  1102 11th Floor Hallmark Business Plaza Gurunanak Hospital Road Near Gurunanak Hospital Bandra East Mumbai Mumbai


MAHARASHTRA
400 051
India 
Phone    
Fax    
Email  sanjay.hake@boehringer-ingelheim.com  
 
Details of Contact Person
Public Query  
Name  Partha Gokhale 
Designation  Head Clinical Operations, India 
Affiliation   
Address  Boehringer Ingelheim India Pvt. Ltd. 1102, 11th Floor, Hallmark Business Plaza, Guru Nanak Hospital Road, Near Guru Nanak Hospital , Bandra (East) Mumbai

Mumbai
MAHARASHTRA
400051
India 
Phone    
Fax    
Email  partha.gokhale@boehringer-ingelheim.com  
 
Source of Monetary or Material Support  
Boehringer Ingelheim 
 
Primary Sponsor  
Name  Boehringer Ingelheim 
Address  Binger Street 173, Ingelheim, Germany 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Canada
Chile
Finland
France
Germany
Greece
Japan
Mexico
Netherlands
Portugal
Republic of Korea
Russian Federation
Spain
Turkey
United States of America
India  
Sites of Study  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashish Kumar  Asthma Bhavan  Respiratory Department, R-3, Sector 6,Vidhyadhar Nagar,
Jaipur
RAJASTHAN 		 919414454196

drashish19@gmail.com 
Dr Sujeet Rajan  Bhatia Hospital  Respiratory Department, G2, Ground Floor Clinic, Tardeo Road
Mumbai
MAHARASHTRA 		 919820191302

skrajan@hotmail.com 
Dr K S Sathish  Chest and Maternity Centre  Chest and Maternity Centre,Respiratory Department, 878 - 5th Block, Rajaji Nagar,
Bangalore
KARNATAKA 		 919886495731

mamthasatish@gmail.com 
Dr Mahendra Kawedia  Jehangir Hospital  Jehangir Hospital, Respiratory Department, 32, Sasson Road
Pune
MAHARASHTRA 		 91206728804

mkawedia@hotmail.com 
Dr Parag G Khatawkar  KEM Hospital  KEM Hospital and Research Center,Respiratory Department, Sardar Moodilar Road,Rastha Peth,
Pune
MAHARASHTRA 		 919890141514

drpgkhatavkar@gmail.com 
Dr Parthiv Mehta  Mehta hospital and Cardio-pulmonary care center  Mehta hospital and Cardio-pulmonary Care Center, Respiratory Department, 2nd Floor,SidhhachalComplex,Nr.T V Tower,Drive In Road,Thaltej,Ahmedabad
Ahmadabad
GUJARAT 		 919825031615

parthiv.mhrc@gmail.com 
Dr T Mohankumar  Sri Ramakrishna Hospital, Coimbatore  Institute of Pulmonary Medicine & Research,Respiratory Department, Sri Ramakrishna Hospital,395 - Sarojini Naidu Road, Avarampalyam,
Coimbatore
TAMIL NADU 		 919894622018

tmkdr@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Bangalore Central Ethics Committee  Approved 
Bhatia Hospital Medical Research Society Ethics Committee  Approved 
Hirabai Cowasji Jehangir Medical Research Institute and Jehangir Clinical Development Center Ethics Committee  Approved 
Institutional Ethics Committee KEM Hospital Research Center, Pune  Approved 
Safe Search Independent Ethics Committee  Approved 
Shri Ramakrishna Hospital Ethical Committee  Not Applicable 
Swasthya Kalyan Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Idiopathic Pulmonary Fibrosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BIBF 1120  Capsules containing BIBF 1120 twice a day for 52 weeks 
Comparator Agent  Placebo  capsules identical to those containing active drug twice a day for 52 weeks 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Age more than or equal to 40 years
IPF diagnosed according to most recent American Thoracic Society European Respiratory Society Japanese Respiratory Society Latin American Thoracic Association IPF guideline for diagnosis and management within 5 years
Combination of High Resolution Computerized Tomography pattern and if available surgical lung biopsy pattern as assessed by central reviewers are consistent with diagnosis of IPF
Dlco that is corrected for Hb is 30%-79% predicted of normal
FVC more than or equal to 50% predicted of normal
 
 
ExclusionCriteria 
Details  Aspartate Aminotransferase Alanine Aminotransferase more than 1.5 x Upper Limit of Normal ULN
Bilirubin more than 1.5 x ULN
Relevant airways obstruction that is pre bronchodilator FEV1/FVC less than 0.7
Patient likely to have lung transplantation during study being on transplantation list is acceptable for participation
Myocardial infarction within 6 months
Unstable angina within 1 month
Bleeding risk that is genetic predisposition or fibrinolysis or full-dose therapeutic anticoagulation or high dose antiplatelet therapy or history of hemorrhagic CNS event within 12 months haemoptysis or haematuria or active gastrointestinal bleeding or ulcers or major injury or surgery within 3 months
Thrombotic risk that is inherited predisposition history of thrombotic event including stroke and transient ischemic attacks within 12 months
International normalised ratio more 2, prolongation of prothrombin time and partial thromboplastin time by more than 50 percent of institutional ULN
N-ACetyl Cystein, prednisone more than 15mg per day or equivalent received within 2 weeks of visit 1
Pirfenidone or azathioprine or cyclophosphamide or cyclosporine A received within 8 weeks of visit 1
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Annual rate of decline in Forced Vital Capacity expressed in mL over 52 weeks  Annual rate of decline in Forced Vital Capacity expressed in mL over 52 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Acute exacerbations: Proportion of patients with at least one acute exacerbation during the 52 weeks. Exacerbation days (defined by number of days with an exacerbation per patient) during the 52 weeks. Number of exacerbations during the 52 weeks  52 weeks 
Change from baseline in Saint-George Respiratory Questionnaire (SGRQ) total score at 52 weeks (expressed in points).  52 weeks 
Further analyses on FVC- Absolute and relative change from baseline of FVC and FVC %pred up to 52 weeks Absolute categorical change of FVC percent up to 52 weeks: decrease by more than 5, increase by more than 5, and change within equal to 5   52 weeks 
On-treatment survival (on-treatment based on fatal adverse event + 28 days).  52 weeks 
Overall survival (all data collected based on randomized set, including vital status follow-up, censored at 52 weeks).  52 weeks 
Patient reported outcomes- changes in SGRQ, Shortness Of Breath Questionnaire (SOBQ), Cough And Sputum Assessment (CASAQ), Patients Global Impression of Change (PGIC), EuroQol 5-Dimensional Quality of Life Questionnaire (EQ5D), up to 52 weeks   52 weeks 
Respiratory mortality (adjudicated; all data collected based on randomized set, including vital status follow-up, censored at 52 weeks).  52 weeks 
Time to death or lung transplant.  52 weeks 
Time to first acute exacerbation (days)  52 weeks 
 
Target Sample Size   Total Sample Size="485"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   17/01/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  03/05/2011 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="2"
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   A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF). Total number patients proposed to be recruited from India is 20. First subject is expected to be enrolled on 17 January 2012.   
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