Clinical trial NCT03208933: Open-label Study to Assess the Effectiveness of Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis (IPF).
Official title: Local Open-label Multicenter Study to Assess the Effectiveness of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis in Russian Clinical Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Pirfenidone, UIP, IPF, FVC
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-07-06
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Change From Baseline to Week 26 in Absolute Millilitre (mL) Forced Vital Capacity (FVC)
timeFrame: Baseline, Week 26
measure: Change From Baseline to Week 26 in Percent (%) Predicted FVC
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: Change From Baseline to Week 26 in 6-Minute Walk Test (6MWT) Distance
timeFrame: Baseline, Week 26
measure: Change From Baseline to Week 26 in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Index Score
timeFrame: Baseline, Week 26
measure: Change From Baseline to Week 26 in EQ-5D-5L Visual Analogue Scale (EQ-5D-5L VAS) Score
timeFrame: Baseline, Week 26
measure: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
timeFrame: Up to Week 52
Other outcomes:
Locations:
city: Barnaul
country: Russian Federation
facility: Regional State Budgetary Institution of Healthcare "Regional Cinilcal Hospital"; Pulmonology
state: Altaj
city: Chelyabinsk
country: Russian Federation
facility: GBUZ Regional clinical hospital #4
state: Evenkija
city: Sankt-peterburg
country: Russian Federation
facility: SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
state: Leningrad
city: Moscow
country: Russian Federation
facility: Central NII tuberkuleza RAMN
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: Pulmonologii NII FMBA of Russia
state: Moskovskaja Oblast
city: Yekaterinburg
country: Russian Federation
facility: New Hospital
state: Sverdlovsk
city: Moscow
country: Russian Federation
facility: I.M. Sechenov First Moscow State Medical University: The E.M. Tareyev Clinic
city: Moscow
country: Russian Federation
facility: Vladimirskiy Regional Scientific Research Inst.
city: Novosibirsk
country: Russian Federation
facility: State Novosibirsk Regional Clinical Hospital
city: UFA
country: Russian Federation
facility: Republican clinical hospital named after G.G. Kuvatov
city: Voronezh
country: Russian Federation
facility: Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: