Open-label Study to Assess the Effectiveness of Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis (IPF).

Roche

Status and phase

Completed

Phase 3

Conditions

Idiopathic Pulmonary Fibrosis

Treatments

Drug: Pirfenidone

Study type

Interventional

Funder types

Industry

Identifiers

NCT03208933

ML39355

Details and patient eligibility

About

This study is a national, multicenter, interventional, non-randomized, non-controlled, open-label study to assess the effectiveness of pirfenidone in participants with IPF in Russian clinical practice.

Enrollment

60 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical symptoms consistent with IPF of ≥ 6months duration
Participants could have both "confident" or "consistent" with UIP diagnosis of IPF based on clinical, radiologic and pathologic data according to 2011 American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines at the Screening. HRCT scan performed within 24 months before the start of the Screening may be used, if it meets all image acquisition guideline
No features supporting an alternative diagnosis on transbronchial biopsy, bronchoalveolar lavage (BAL), or surgical lung biopsy, if performed. Results of the surgical lung biopsy performed within the last 4 years must be confirmed by central review
Participants with %FVC ≥ 40 % at the Screening
Participants with %Carbon monoxide diffusing capacity (DLCO) ≥ 30 % at the Screening
Ability to walk ≥ 100 m during the 6-minute walk test at the Screening
Eligible participants must discontinue all prohibited medications at least 28 days before the Screening
Female participants of childbearing potential must have negative urine pregnancy test at the Screening and before first dosing on Day 1

Exclusion criteria

Significant clinical worsening of IPF between Screening and Day 1, in the opinion of the investigator
Relevant airways obstruction (i.e. pre-bronchodilator forced expiratory volume (FEV)1/FVC < 0.7)
Cigarette smoking within 28 days before the start of treatment or unwilling to avoid tobacco products throughout the study
History of clinically significant environmental exposure known to cause pulmonary fibrosis (PF), including but not limited to drugs (such as amiodarone), asbestos, beryllium, radiation, and domestic birds
Known explanation for interstitial lung disease, including but not limited to radiation, drug toxicity, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis, and cancer
Clinical diagnosis of any connective tissue disease, including but not limited to scleroderma, polymyositis/ dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis
During baseline analysis of HRCT, significant coexistent emphysema (emphysema extent greater than extent of fibrosis) confirmed by central review
Planned lung transplantation during the study
Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis, urinary tract infection, or cellulitis
Unable to perform 6MWT or to undergo pulmonary function test
Any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 1 years. This does not include minor surgical procedures for localized cancer (e.g., basal cell carcinoma)
History of severe hepatic impairment or end-stage liver disease
History of end-stage renal disease requiring dialysis
History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months
Pregnancy or lactation, or intention to become pregnant during the study. Women of childbearing capacity are required to have a negative urine pregnancy test before treatment and must agree to maintain highly effective contraception
Liver function test outside specified limits at the Screening: total bilirubin above the upper limit of normal (ULN); aspartate or alanine aminotransferase (AST or ALT) > 3 × ULN; alkaline phosphatase > 2.5 × ULN
Creatinine clearance < 30 mL/min, calculated using the Cockcroft-Gault formula
Electrocardiogram (ECG) with a QT interval corrected according to Fridericia's formula (QTcF) > 500 msec at the Screening