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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 : Completed
First Posted : July 6, 2017
Results First Posted : November 20, 2020
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Idiopathic Pulmonary Fibrosis
Intervention Drug: Pirfenidone
Enrollment 60
Recruitment Details The study enrolled participants in Russia.
Pre-assignment Details  
Arm/Group Title Pirfenidone
Hide Arm/Group Description Participants administered pirfenidone 2403 milligram per day (mg/d) orally for 26 weeks
Period Title: Overall Study
Started 60
Completed 47
Not Completed 13
Reason Not Completed
Death             3
Withdrawal by Subject             3
Adverse Event             1
Lost to Follow-up             2
Physician Decision             3
Protocol Violation             1
Arm/Group Title Pirfenidone
Hide Arm/Group Description Participants administered pirfenidone 2403 milligram per day (mg/d) orally for 26 weeks
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants
67.4  (7.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
19
  31.7%
Male
41
  68.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Russian
48
  80.0%
Tatar
4
   6.7%
Bashkir
4
   6.7%
Armenian
1
   1.7%
Dagestani
1
   1.7%
Kazah
1
   1.7%
Uzbek
1
   1.7%
1.Primary Outcome
Title Change From Baseline to Week 26 in Absolute Millilitre (mL) Forced Vital Capacity (FVC)
Hide Description 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.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Included participants that had data for at least one post-baseline assessment of any efficacy measurement
Arm/Group Title Pirfenidone
Hide Arm/Group Description:
Participants administered pirfenidone 2403 milligram per day (mg/d) orally for 26 weeks
Overall Number of Participants Analyzed 55
Mean (95% Confidence Interval)
Unit of Measure: Milliliter (mL)
128.78
(-26.84 to 284.40)
2.Primary Outcome
Title Change From Baseline to Week 26 in Percent (%) Predicted FVC
Hide Description Predicted FVC is based on sex, age, and height of a person. Percent predicted FVC (in %) = [(observed FVC)/(predicted FVC)]*100.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Included participants that had data for at least one post-baseline assessment of any efficacy measurement
Arm/Group Title Pirfenidone
Hide Arm/Group Description:
Participants administered pirfenidone 2403 milligram per day (mg/d) orally for 26 weeks
Overall Number of Participants Analyzed 55
Mean (95% Confidence Interval)
Unit of Measure: percent predicted
-0.10
(-3.18 to 2.99)
3.Secondary Outcome
Title Change From Baseline to Week 26 in 6-Minute Walk Test (6MWT) Distance
Hide Description 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.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Included participants that had data for at least one post-baseline assessment of any efficacy measurement and for the 6MWT at Week 26
Arm/Group Title Pirfenidone
Hide Arm/Group Description:
Participants administered pirfenidone 2403 milligram per day (mg/d) orally for 26 weeks
Overall Number of Participants Analyzed 49
Measure Type: Count of Participants
Unit of Measure: Participants
Decline of >= 50 m
14
  28.6%
Decline of <50 m to 0 m
11
  22.4%
Improvement of >= 0 m
24
  49.0%
4.Secondary Outcome
Title Change From Baseline to Week 26 in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Index Score
Hide Description 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.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Included participants that had data for at least one post-baseline assessment of any efficacy measurement
Arm/Group Title Pirfenidone
Hide Arm/Group Description:
Participants administered pirfenidone 2403 milligram per day (mg/d) orally for 26 weeks
Overall Number of Participants Analyzed 55
Mean (Standard Deviation)
Unit of Measure: score on scale
-0.0288  (0.1820)
5.Secondary Outcome
Title Change From Baseline to Week 26 in EQ-5D-5L Visual Analogue Scale (EQ-5D-5L VAS) Score
Hide Description 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.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Included participants that had data for at least one post-baseline assessment of any efficacy measurement
Arm/Group Title Pirfenidone
Hide Arm/Group Description:
Participants administered pirfenidone 2403 milligram per day (mg/d) orally for 26 weeks
Overall Number of Participants Analyzed 55
Mean (Standard Deviation)
Unit of Measure: score on scale
-0.6  (17.16)
6.Secondary Outcome
Title Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Hide Description 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.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pirfenidone
Hide Arm/Group Description:
Participants administered pirfenidone 2403 milligram per day (mg/d) orally for 26 weeks
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: percentage of participants
TEAEs 81.7
TESAEs 16.7
Time Frame Up to 52 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pirfenidone
Hide Arm/Group Description Participants administered pirfenidone 2403 milligram per day (mg/d) orally for 26 weeks
All-Cause Mortality
Pirfenidone
Affected / at Risk (%)
Total   7/60 (11.67%)    
Hide Serious Adverse Events
Pirfenidone
Affected / at Risk (%) # Events
Total   10/60 (16.67%)    
Cardiac disorders   
Atrial fibrillation  1  1/60 (1.67%)  1
Atrial flutter  1  1/60 (1.67%)  1
General disorders   
Death  1  2/60 (3.33%)  2
Sudden cardiac death  1  1/60 (1.67%)  1
Infections and infestations   
Bronchitis bacterial  1  1/60 (1.67%)  1
Cholecystitis infective  1  1/60 (1.67%)  1
Pneumonia  1  1/60 (1.67%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Adenocarcinoma of colon  1  1/60 (1.67%)  1
Respiratory, thoracic and mediastinal disorders   
Idiopathic pulmonary fibrosis  1  2/60 (3.33%)  3
Bronchitis chronic  1  1/60 (1.67%)  1
Dyspnoea  1  1/60 (1.67%)  1
1
Term from vocabulary, MedDRA version 22.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pirfenidone
Affected / at Risk (%) # Events
Total   32/60 (53.33%)    
Gastrointestinal disorders   
Nausea  1  16/60 (26.67%) 
Dyspepsia  1  8/60 (13.33%) 
Vomiting  1  8/60 (13.33%) 
Diarrhoea  1  7/60 (11.67%) 
Investigations   
Weight decreased  1  4/60 (6.67%) 
Metabolism and nutrition disorders   
Decreased appetite  1  13/60 (21.67%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  6/60 (10.00%) 
Cough  1  4/60 (6.67%) 
Skin and subcutaneous tissue disorders   
Pruritus  1  4/60 (6.67%) 
1
Term from vocabulary, MedDRA version 22.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03208933    
Other Study ID Numbers: ML39355
First Submitted: June 26, 2017
First Posted: July 6, 2017
Results First Submitted: October 20, 2020
Results First Posted: November 20, 2020
Last Update Posted: November 20, 2020