Open-label Study to Assess the Effectiveness of Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis (IPF).
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03208933|
Recruitment Status : Completed
First Posted : July 6, 2017
Results First Posted : November 20, 2020
Last Update Posted : November 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Pulmonary Fibrosis||Drug: Pirfenidone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||November 13, 2019|
|Actual Study Completion Date :||November 13, 2019|
Participants will be administered pirfenidone 2403 milligram per day (mg/d) orally for 26 weeks in participants with IPF.
Pirfenidone 2403 mg/d capsules orally will be given in divided doses (TID) after titration period of 14 days.
Other Name: Esbriet, RO0220912
- 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.
- 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.
- Change From Baseline to Week 26 in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Index Score [ Time Frame: Baseline, Week 26 ]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.
- Change From Baseline to Week 26 in EQ-5D-5L Visual Analogue Scale (EQ-5D-5L VAS) Score [ Time Frame: Baseline, Week 26 ]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.
- Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [ Time Frame: Up to 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.
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
|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|
|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|
|Study Director:||Clinical Trials||Hoffmann-La Roche|