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

NCT ID: NCT03208933

Last Updated: 2020-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-23
• Study Completion Date: 2019-11-13

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Pirfenidone, UIP, IPF, FVC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pirfenidone

Participants will be administered pirfenidone 2403 milligram per day (mg/d) orally for 26 weeks in participants with IPF.

Group Type: EXPERIMENTAL

Pirfenidone

Intervention Type: DRUG

Pirfenidone 2403 mg/d capsules orally will be given in divided doses (TID) after titration period of 14 days.

Interventions

Pirfenidone

Pirfenidone 2403 mg/d capsules orally will be given in divided doses (TID) after titration period of 14 days.

Intervention Type: DRUG

Other Intervention Names

Esbriet, RO0220912

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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

Barnaul, Altayskiy Kray, Russia

GBUZ Regional clinical hospital #4

Chelyabinsk, Evenkija, Russia

Central NII tuberkuleza RAMN

Moscow, Moscow Oblast, Russia

Pulmonologii NII FMBA of Russia

Moscow, Moscow Oblast, Russia

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

Saint Petersburg, Sankt-Peterburg, Russia

New Hospital

Yekaterinburg, Sverdlovsk Oblast, Russia

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

Moscow, , Russia

Vladimirskiy Regional Scientific Research Inst.

Moscow, , Russia

State Novosibirsk Regional Clinical Hospital

Novosibirsk, , Russia

Republican clinical hospital named after G.G. Kuvatov

Ufa, , Russia

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

Voronezh, , Russia

Countries

Russia

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ML39355

Identifier Type: -

Identifier Source: org_study_id