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

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ClinicalTrials.gov Identifier: NCT03208933
Recruitment Status : Active, not recruiting
First Posted : July 6, 2017
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: Pirfenidone Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Local Open-label Multicenter Study to Assess the Effectiveness of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis in Russian Clinical Practice
Actual Study Start Date : October 23, 2017
Estimated Primary Completion Date : June 24, 2020
Estimated Study Completion Date : June 24, 2020


Arm Intervention/treatment
Experimental: Pirfenidone
Participants will be administered pirfenidone 2403 milligram per day (mg/d) orally for 26 weeks in participants with IPF.
Drug: Pirfenidone
Pirfenidone 2403 mg/d capsules orally will be given in divided doses (TID) after titration period of 14 days.
Other Name: Esbriet, RO0220912




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

  2. Change From Baseline to Week 26 in Absolute Millilitre (mL) % FVC [ Time Frame: Baseline, Week 26 ]
    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.


Secondary Outcome Measures :
  1. Change From Baseline to Week 26 in 6-Minute Walk Test (6MWT) Distance [ Time Frame: Baseline, Week 26 ]
    Baseline 6MWT distance will be the average of the measurements recorded at the Screening and Day 1 visits. The 6MWT distance at Week 26 will be defined as the average of the 6MWT distance recorded on two separate days at Week 26.

  2. Change From Baseline to Week 26 in Participants' Quality of Life as Measured With European Quality of Life 5-Dimension Questionnaire (EQ-5D) [ Time Frame: Baseline, Week 26 ]
    The European Quality of Life (EuroQol) 5-Dimension Questionnaire, 3-level version (EQ-5D-5L), is a self-report health status questionnaire that consists of six questions used to calculate a health utility score. There are two components to the EuroQol EQ-5D: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a visual analogue scale (VAS) that measures health state. Overall scores range from 0 to 1, with low scores representing a higher level of dysfunction.

  3. Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [ Time Frame: Baseline, Week 52 ]
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. Serious adverse event is any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect.

  4. Number of Participants With Markedly Abnormal Laboratory Values and Electrocardiogram (ECG) Parameters [ Time Frame: Baseline, Week 52 ]
    The number of participants with any markedly abnormal standard safety laboratory values or who meet markedly abnormal criteria for ECG will be reported.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208933


Locations
Russian Federation
Regional State Budgetary Institution of Healthcare "Regional Cinilcal Hospital"; Pulmonology
Barnaul, Altaj, Russian Federation, 656024
GBUZ Regional clinical hospital #4
Chelyabinsk, Evenkija, Russian Federation
SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
Sankt-peterburg, Leningrad, Russian Federation, 197022
Central NII tuberkuleza RAMN
Moscow, Moskovskaja Oblast, Russian Federation
Pulmonologii NII FMBA of Russia
Moscow, Moskovskaja Oblast, Russian Federation
New Hospital
Yekaterinburg, Sverdlovsk, Russian Federation
I.M. Sechenov First Moscow State Medical University: The E.M. Tareyev Clinic
Moscow, Russian Federation, 119992
Vladimirskiy Regional Scientific Research Inst.
Moscow, Russian Federation, 129110
State Novosibirsk Regional Clinical Hospital
Novosibirsk, Russian Federation, 630087
Republican clinical hospital named after G.G. Kuvatov
UFA, Russian Federation, 450005
Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"
Voronezh, Russian Federation, 394066
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03208933     History of Changes
Other Study ID Numbers: ML39355
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: CT images of lungs, forced vital capacity (FVC) measurements, post-hoc analysis

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Hoffmann-La Roche:
Pirfenidone, UIP, IPF, FVC

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Pirfenidone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents