A randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-Arm Study of the Safety and Efficacy of Pirferidone in patients with Idiopathic Pulmonary Fibrosis - ND

• Conditions: Idiopathic pulmonary fibrosis IPF ICD X J84.1other interstitial pulmonary; MedDRA version: 6.1Level: PTClassification code 10037383

• Registration Number: EUCTR2006-000252-41-IT
• Lead Sponsor: INTERMUNE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 325

Inclusion Criteria

Clinical symptoms consistent with IPF of 3 months duration Diagnosis of IPF within 48 months of randomization Age 40 through 80 years, inclusive High-resolution computed tomographic HRCT scan showing a pattern of disease consistent with a confident definite radiographic diagnosis of usual interstitial pneumonia UIP /IPF. For patients with surgical lung biopsy showing definite or probable UIP, the HRCT criterion of probable IPF is sufficient. For patients aged 50 years open or video-assisted thoracoscopic VATS lung biopsy showing definite or probable UIP within 48 months of randomization. In addition, there are no features supporting an alternative diagnosis on transbronchial biopsy or bronchoalveolar lavage BAL if performed. For patients aged 50 years At least one of the following diagnostic findings, as well as the absence of any features on specimens resulting from any of these procedures that support an alternative diagnosis, within 48 months of randomization Open or VATS lung biopsy showing definite or probable UIP Transbronchial biopsy showing no features to support an alternative diagnosis BAL showing no features to support an alternative diagnosis
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study, in the opinion of the investigator Premature withdrawal from a randomized IPF clinical trial in the previous 2 years for any reason other than Sponsor decision or current participation in a clinical drug trial Forced expiratory volume in the first second FEV1 /FVC ratio 0.7 after administration of bronchodilator Bronchodilator Response defined by an absolute increase in FEV1 or FVC of 8805;12 predicted or 200 mL after bronchodilator use The change in FVC between the Screen Visit and Day 1 Baseline cannot vary by more than 10 absolute difference and the Bronchodilator Response, Baseline FVC and FEV1/FVC ratio must all continue to meet the inclusion and exclusion criteria Residual volume RV 120 of predicted before administration of bronchodilator History of clinically significant environmental exposure known to cause pulmonary fibrosis including but not limited to drugs, asbestos, beryllium, radiation, domestic birds Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, human immunodeficiency virus HIV , viral hepatitis and cancer Diagnosis of any connective tissue disease, including but not limited to scleroderma, systemic lupus erythematosus, and rheumatoid arthritis Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis, urinary tract infection, or cellulitis On a lung transplantation waiting list at time of randomization Unable to undergo pulmonary function testing

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified