Nintedanib Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)
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This is an 6 month multi-centre, prospective, randomized, placebo controlled, double blind clinical trial followed by conversion of each arm to active nintedanib for an additional 6 months comparing the effect of nintedanib 150mg BID on the progression of IPF measured by using HRCT, lung function, 6MWT, biomarkers, and PROs with continued treatment and assessments for up to 18 months.
A Six Month Double Blind Randomized Placebo Controlled Trial Followed by Each Arm Being Converted to Oral Nintedanib 150 mg Twice Daily Comparing the Effect on High Resolution Computerized Tomography Quantitative Lung Fibrosis Score, Lung Function, Six Minute Walk Test Distance and St. George¿s Respiratory Questionnaire After Six Months of Treatment in Patients With Idiopathic Pulmonary Fibrosis With Continued Evaluations Over a Period of up to Eighteen Months
Actual Study Start Date
November 26, 2013
Primary Completion Date
July 18, 2016
Study Completion Date
October 27, 2016
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Ages Eligible for Study:
40 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Written Informed Consent consistent with International Conference on Harmonisation Good Clinical Practice (ICH-GCP) and local laws signed prior to entry into the study
Patient aged >= 40 years at Visit 1.
IPF diagnosed, according to the 2011 ATS/ERS/JRS/ALAT IPF guidelines for diagnosis and management, within 5 years and reaffirmed applying 2011 Guidelines (P11-07084) if diagnosed >2 years and up to 5 year from Visit 1,. Diagnosis must be confirmed by chest HRCT taken within 24 months of Visit 1. All HRCT results reported to be possible or inconsistent usual interstitial pneumonia (UIP) must have confirmatory pathology.
DLCO (corrected for Hb): 30%-79% predicted of normal
FVC >= 50% predicted of normal at Visit 1 and Visit 2
AST, ALT > 1.5 fold ULN
Bilirubin > 1.5 fold ULN
Patients who require fibrinolysis, full-dose therapeutic anticoagulation (e.g. 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 (e.g. enoxaparin 4000 IU s.c. per day) and prophylactic use of antiplatelet therapy (e.g. acetyl salicylic acid up to 325 mg/d, or clopidogrel at 75 mg/d, or equivalent doses of other antiplatelet therapy)
History of hemorrhagic Central Nervous System (CNS) event within 12 months
Any of the following within 3 months:
Haemoptysis or haematuria.
Active gastro-intestinal bleeding or ulcers.
Major injury or surgery.
Coagulation parameters: International normalised ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 150% of institutional ULN.
Planned major surgery within the next 3 months, including lung transplantation, major abdominal or major intestinal surgery.
Known inherited predisposition to thrombosis.
History of thrombotic event (including stroke and transient ischemic attacks) within 12 months
Current or planned usage of any investigational drug during the course of this trial
Previous treatment with nintedanib within a clinical trial in the previous 3 months and discontinuation of nintedanib study treatment due to an adverse event
Known hypersensitivity to the trial drug or its component
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 patient's ability to participate in this trial. Patients will be excluded if they require greater than 12L/min oxygen, are not ambulatory or require use of a walker or cane during the 6 Minute Titration Walk Test. Patients who cannot complete the 6 Minute Titration Walk Test are excluded from participation.
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 non-barrier) for at least 1 month prior to trial and/or not committing to using it until 3 months after end of treatment.