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

Last updated: November 18, 2020
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Cystic Fibrosis

Lung Injury

Pulmonary Fibrosis

Treatment

N/A

Clinical Study ID

NCT03208933
ML39355
  • Ages 40-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical symptoms consistent with IPF of ≥ 6months duration
  • Participants could have both "confident" or "consistent" with UIP diagnosis of IPFbased on clinical, radiologic and pathologic data according to 2011 American ThoracicSociety/European Respiratory Society (ATS/ERS) guidelines at the Screening. HRCT scanperformed within 24 months before the start of the Screening may be used, if it meetsall image acquisition guideline
  • No features supporting an alternative diagnosis on transbronchial biopsy,bronchoalveolar lavage (BAL), or surgical lung biopsy, if performed. Results of thesurgical lung biopsy performed within the last 4 years must be confirmed by centralreview
  • 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 daysbefore the Screening
  • Female participants of childbearing potential must have negative urine pregnancy testat the Screening and before first dosing on Day 1

Exclusion

Exclusion Criteria:

  • Significant clinical worsening of IPF between Screening and Day 1, in the opinion ofthe 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 avoidtobacco products throughout the study
  • History of clinically significant environmental exposure known to cause pulmonaryfibrosis (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 toradiation, drug toxicity, sarcoidosis, hypersensitivity pneumonitis, bronchiolitisobliterans organizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis,and cancer
  • Clinical diagnosis of any connective tissue disease, including but not limited toscleroderma, polymyositis/ dermatomyositis, systemic lupus erythematosus, andrheumatoid arthritis
  • During baseline analysis of HRCT, significant coexistent emphysema (emphysema extentgreater 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 torequire significant medical or surgical intervention within the next 1 years. Thisdoes not include minor surgical procedures for localized cancer (e.g., basal cellcarcinoma)
  • 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 ofchildbearing capacity are required to have a negative urine pregnancy test beforetreatment and must agree to maintain highly effective contraception
  • Liver function test outside specified limits at the Screening: total bilirubin abovethe 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

Study Design

Total Participants: 60
Study Start date:
October 23, 2017
Estimated Completion Date:
November 13, 2019

Connect with a study center

  • Regional State Budgetary Institution of Healthcare "Regional Cinilcal Hospital"; Pulmonology

    Barnaul, Altaj 656024
    Russian Federation

    Site Not Available

  • GBUZ Regional clinical hospital #4

    Chelyabinsk, Evenkija
    Russian Federation

    Site Not Available

  • SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

    Sankt-peterburg, Leningrad 197022
    Russian Federation

    Site Not Available

  • Central NII tuberkuleza RAMN

    Moscow, Moskovskaja Oblast
    Russian Federation

    Site Not Available

  • Pulmonologii NII FMBA of Russia

    Moscow, Moskovskaja Oblast
    Russian Federation

    Site Not Available

  • SBI at Rostov Region "Regional Clinical Hospital #2"

    Rostov-na-donu, Rostov 344029
    Russian Federation

    Site Not Available

  • New Hospital

    Yekaterinburg, Sverdlovsk
    Russian Federation

    Site Not Available

  • Region Cinical Hospital; Gastroenterology

    Krasnoyarsk, 660022
    Russian Federation

    Site Not Available

  • I.M. Sechenov First Moscow State Medical University: The E.M. Tareyev Clinic

    Moscow, 119992
    Russian Federation

    Site Not Available

  • Vladimirskiy Regional Scientific Research Inst.

    Moscow, 129110
    Russian Federation

    Site Not Available

  • State Novosibirsk Regional Clinical Hospital

    Novosibirsk, 630087
    Russian Federation

    Site Not Available

  • SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

    St Petersburg, 197089
    Russian Federation

    Site Not Available

  • Republican clinical hospital named after G.G. Kuvatov

    UFA, 450005
    Russian Federation

    Site Not Available

  • Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"

    Voronezh, 394066
    Russian Federation

    Site Not Available

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