Phase 3
N=60
Open-label Study to Assess the Effectiveness of Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis (IPF).
Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT03208933 ↗Enrolled (actual)
60
Serious AEs
16.7%
Results posted
Nov 2020
Primary outcome: Primary: Change From Baseline to Week 26 in Absolute Millilitre (mL) Forced Vital Capacity (FVC) — 128.78 Milliliter (mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pirfenidone (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 26 in Absolute Millilitre (mL) Forced Vital Capacity (FVC) |
128.78 | — |
| PRIMARY Change From Baseline to Week 26 in Percent (%) Predicted FVC |
-0.10 | — |
| SECONDARY Change From Baseline to Week 26 in 6-Minute Walk Test (6MWT) Distance |
14; 11; 24 | — |
| SECONDARY Change From Baseline to Week 26 in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Index Score |
-0.0288 | — |
| SECONDARY Change From Baseline to Week 26 in EQ-5D-5L Visual Analogue Scale (EQ-5D-5L VAS) Score |
-0.6 | — |
| SECONDARY Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) |
81.7; 16.7 | — |
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.
Eligibility 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 3 × ULN; alkaline phosphatase > 2.5 × ULN
- Creatinine clearance 500 msec at the Screening
Data sourced from ClinicalTrials.gov (NCT03208933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.