Phase
Condition
Cystic Fibrosis
Lung Injury
Pulmonary Fibrosis
Treatment
N/AClinical Study ID
Ages 40-80 All Genders
Study Summary
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
Connect with a study center
Regional State Budgetary Institution of Healthcare "Regional Cinilcal Hospital"; Pulmonology
Barnaul, Altaj 656024
Russian FederationSite Not Available
GBUZ Regional clinical hospital #4
Chelyabinsk, Evenkija
Russian FederationSite 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 FederationSite Not Available
Central NII tuberkuleza RAMN
Moscow, Moskovskaja Oblast
Russian FederationSite Not Available
Pulmonologii NII FMBA of Russia
Moscow, Moskovskaja Oblast
Russian FederationSite Not Available
SBI at Rostov Region "Regional Clinical Hospital #2"
Rostov-na-donu, Rostov 344029
Russian FederationSite Not Available
New Hospital
Yekaterinburg, Sverdlovsk
Russian FederationSite Not Available
Region Cinical Hospital; Gastroenterology
Krasnoyarsk, 660022
Russian FederationSite Not Available
I.M. Sechenov First Moscow State Medical University: The E.M. Tareyev Clinic
Moscow, 119992
Russian FederationSite Not Available
Vladimirskiy Regional Scientific Research Inst.
Moscow, 129110
Russian FederationSite Not Available
State Novosibirsk Regional Clinical Hospital
Novosibirsk, 630087
Russian FederationSite 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 FederationSite Not Available
Republican clinical hospital named after G.G. Kuvatov
UFA, 450005
Russian FederationSite Not Available
Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"
Voronezh, 394066
Russian FederationSite Not Available
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