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

NCT03208933 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: ML39355
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 11

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

Outcome Measures

Primary Outcomes (2)

• Change From Baseline to Week 26 in Absolute Millilitre (mL) Forced Vital Capacity (FVC)

  FVC is a standard pulmonary function test. FVC is defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Baseline FVC will be the average of the highest FVC measurement recorded at the Screening and Day 1. The FVC at Week 26 will be the average of the highest FVC measurement recorded on two separate days at Week 26.

  Baseline, Week 26

• Change From Baseline to Week 26 in Percent (%) Predicted FVC

  Predicted FVC is based on sex, age, and height of a person. Percent predicted FVC (in %) = \[(observed FVC)/(predicted FVC)\]\*100.

  Baseline, Week 26

Secondary Outcomes (4)

• Change From Baseline to Week 26 in 6-Minute Walk Test (6MWT) Distance

  Baseline, Week 26

• Change From Baseline to Week 26 in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Index Score

  Baseline, Week 26

• Change From Baseline to Week 26 in EQ-5D-5L Visual Analogue Scale (EQ-5D-5L VAS) Score

  Baseline, Week 26

• Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

  Up to Week 52

Study Arms (1)

Pirfenidone

EXPERIMENTAL

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

Drug: Pirfenidone

Interventions

Pirfenidone DRUG

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

Also known as: Esbriet, RO0220912

Pirfenidone

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (11)

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

Barnaul, Altayskiy Kray, 656024, Russia

Location

GBUZ Regional clinical hospital #4

Chelyabinsk, Evenkija, Russia

Location

Central NII tuberkuleza RAMN

Moscow, Moscow Oblast, Russia

Location

Pulmonologii NII FMBA of Russia

Moscow, Moscow Oblast, Russia

Location

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

Saint Petersburg, Sankt-Peterburg, 197022, Russia

Location

New Hospital

Yekaterinburg, Sverdlovsk Oblast, Russia

Location

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

Moscow, 119992, Russia

Location

Vladimirskiy Regional Scientific Research Inst.

Moscow, 129110, Russia

Location

State Novosibirsk Regional Clinical Hospital

Novosibirsk, 630087, Russia

Location

Republican clinical hospital named after G.G. Kuvatov

Ufa, 450005, Russia

Location

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

Voronezh, 394066, Russia

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: July 6, 2017
• Study Start: October 23, 2017
• Primary Completion: November 13, 2019
• Study Completion: November 13, 2019
• Last Updated: November 20, 2020
• Results First Posted: November 20, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share

Locations

RU (11)