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

  • Idiopathic Pulmonary Fibrosis
Trial Status:

Completed

This trial runs in
Countries
  • Russia
Trial Identifier:

NCT03208933 ML39355

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial Summary

      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.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT03208933 , ML39355 Trial Identifier
      Pirfenidone Treatments
      Idiopathic Pulmonary Fibrosis Condition
      Official Title

      Local Open-label Multicenter Study to Assess the Effectiveness of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis in Russian Clinical Practice

      Eligibility Criteria

      All Gender
      ≥ 40 Years & ≤ 80 Years Age
      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

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