Idiopathic Pulmonary FibrosisPhase 3NCT03208933
Open-label Study to Assess the Effectiveness of Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis (IPF).
A Phase 3 study testing Pirfenidone in people with Idiopathic Pulmonary Fibrosis, run by Hoffmann-La Roche at 11 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Pirfenidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 11 sitesRussia
- Study dates
- 23 Oct 2017to 13 Nov 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Russia11 sites
Regional State Budgetary Institution of Healthcare "Regional Cinilcal Hospital"; Pulmonology
Barnaul, Altayskiy Kray, 656024
GBUZ Regional clinical hospital #4
Chelyabinsk, Evenkija
Central NII tuberkuleza RAMN
Moscow, Moscow Oblast
Pulmonologii NII FMBA of Russia
Moscow, Moscow Oblast
I.M. Sechenov First Moscow State Medical University: The E.M. Tareyev Clinic
Moscow, 119992
Vladimirskiy Regional Scientific Research Inst.
Moscow, 129110
State Novosibirsk Regional Clinical Hospital
Novosibirsk, 630087
SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
Saint Petersburg, Sankt-Peterburg, 197022
Republican clinical hospital named after G.G. Kuvatov
Ufa, 450005
Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"
Voronezh, 394066
New Hospital
Yekaterinburg, Sverdlovsk Oblast
About this study
Official title: Local Open-label Multicenter Study to Assess the Effectiveness of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis in Russian Clinical Practice
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
- Being tested
- Pirfenidone
- Keywords
- Pirfenidone, UIP, IPF, FVC
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirfenidoneDrug
Also called Esbriet, RO0220912
Pirfenidone 2403 mg/d capsules orally will be given in divided doses (TID) after titration period of 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Pirfenidone | Experimental | Participants will be administered pirfenidone 2403 milligram per day (mg/d) orally for 26 weeks in participants with IPF. Receives: Drug: Pirfenidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 26
Secondary outcomes (4)
Change From Baseline to Week 26 in 6-Minute Walk Test (6MWT) Distance
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.
Measured: Baseline, Week 26
Change From Baseline to Week 26 in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Index Score
The EQ-5D-5L is a self-reported health status questionnaire that consists of six questions used to calculate a health utility score for use in health economic analysis. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, 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.
Measured: Baseline, Week 26
Change From Baseline to Week 26 in EQ-5D-5L Visual Analogue Scale (EQ-5D-5L VAS) Score
The EQ-5D-5L is a self-reported health status questionnaire that consists of six questions used to calculate a health utility score for use in health economic analysis. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a visual analogue scale (VAS) that measures health state. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Measured: Baseline, Week 26
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
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.
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start23 Oct 2017
- Primary completion13 Nov 2019
- Study completion13 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208933
- Sponsor's protocol ID
- ML39355
- Status last verified
- Nov 2020
- First submitted
- 26 Jun 2017
- Last updated
- 20 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: CT images of lungs, forced vital capacity (FVC) measurements, post-hoc analysis
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Open-label Multicenter Study to Assess the Effectiveness of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis in Russian Clinical Practice
- ClinicalTrials.gov ID
- NCT03208933
- Acronym / sponsor ID
- ML39355
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Pirfenidone, UIP, IPF, FVC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 13 Nov 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Posted 20 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pirfenidone | Experimental | Drug: PirfenidoneParticipants will be administered pirfenidone 2403 milligram per day (mg/d) orally for 26 weeks in participants with IPF. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PirfenidoneAlso: Esbriet, RO0220912Pirfenidone 2403 mg/d capsules orally will be given in divided doses (TID) after titration period of 14 days. | Drug | Pirfenidone |
Primary outcome
Change From Baseline to Week 26 in Absolute Millilitre (mL) Forced Vital Capacity (FVC)
Time frame: Baseline, Week 26
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.
Change From Baseline to Week 26 in Percent (%) Predicted FVC
Time frame: Baseline, Week 26
Predicted FVC is based on sex, age, and height of a person. Percent predicted FVC (in %) = [(observed FVC)/(predicted FVC)]*100.
4 secondary outcomes
Change From Baseline to Week 26 in 6-Minute Walk Test (6MWT) Distance
Time frame: Baseline, Week 26
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
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: Up to Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. CT images of lungs, forced vital capacity (FVC) measurements, post-hoc analysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pirfenidone in people with Idiopathic Pulmonary Fibrosis, run by Hoffmann-La Roche at 11 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Week 26 in Absolute Millilitre (mL) Forced Vital Capacity (FVC) (time frame: Baseline, Week 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.