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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03208933
• Date of registration: 26/06/2017
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: Open-label Study to Assess the Effectiveness of Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis (IPF).
• Scientific title: Local Open-label Multicenter Study to Assess the Effectiveness of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis in Russian Clinical Practice
• Date of first enrolment: October 23, 2017
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03208933
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Russian Federation

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: Pirfenidone

Primary Outcome(s)

Change From Baseline to Week 26 in Percent (%) Predicted FVC [Time Frame: Baseline, Week 26]

Change From Baseline to Week 26 in Absolute Millilitre (mL) Forced Vital Capacity (FVC) [Time Frame: Baseline, Week 26]

Secondary Outcome(s)

Change From Baseline to Week 26 in 6-Minute Walk Test (6MWT) Distance [Time Frame: Baseline, Week 26]

Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [Time Frame: Up to Week 52]

Change From Baseline to Week 26 in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Index Score [Time Frame: Baseline, Week 26]

Change From Baseline to Week 26 in EQ-5D-5L Visual Analogue Scale (EQ-5D-5L VAS) Score [Time Frame: Baseline, Week 26]

Secondary ID(s)

ML39355

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 20/11/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03208933