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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03208933|
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : August 22, 2018
|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)|
|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|
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 ]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 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.
- 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 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.
- 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.
- 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.
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
|Contact: Reference Study Id Number ML39355 www.roche.com/about_roche/roche_worldwide.htm||888-662-6728 ext +email@example.com|
|Regional State Budgetary Institution of Healthcare "Regional Cinilcal Hospital"; Pulmonology||Recruiting|
|Barnaul, Altaj, Russian Federation, 656024|
|GBUZ Regional clinical hospital #4||Active, not recruiting|
|Chelyabinsk, Evenkija, Russian Federation|
|SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF||Active, not recruiting|
|Sankt-peterburg, Leningrad, Russian Federation, 197022|
|Central NII tuberkuleza RAMN||Active, not recruiting|
|Moscow, Moskovskaja Oblast, Russian Federation|
|Pulmonologii NII FMBA of Russia||Active, not recruiting|
|Moscow, Moskovskaja Oblast, Russian Federation|
|Yekaterinburg, Sverdlovsk, Russian Federation|
|Region Cinical Hospital; Gastroenterology||Withdrawn|
|Krasnoyarsk, Russian Federation, 660022|
|I.M. Sechenov First Moscow State Medical University: The E.M. Tareyev Clinic||Recruiting|
|Moscow, Russian Federation, 119992|
|Vladimirskiy Regional Scientific Research Inst.||Recruiting|
|Moscow, Russian Federation, 129110|
|State Novosibirsk Regional Clinical Hospital||Active, not recruiting|
|Novosibirsk, Russian Federation, 630087|
|Republican clinical hospital named after G.G. Kuvatov||Active, not recruiting|
|UFA, Russian Federation, 450005|
|Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"||Recruiting|
|Voronezh, Russian Federation, 394066|
|Study Director:||Clinical Trials||Hoffmann-La Roche|