Three-Arm Study of the Safety & Efficacy of Pirfenidone in Patients With

Status Completed

Clinical Trial Summary

The objectives of this study are to assess the safety and efficacy of treatment with pirfenidone 2403 milligrams per day (mg/d) compared with placebo in patients with idiopathic pulmonary fibrosis (IPF), to assess the safety and efficacy of treatment with pirfenidone 1197 mg/d in patients with idiopathic pulmonary fibrosis and to characterize the pharmacokinetic disposition of pirfenidone in patients with idiopathic pulmonary fibrosis.

Clinical Trial Description

This is a Phase 3, randomized, double blind, placebo-controlled, three-arm, safety and efficacy study of pirfenidone in patients with idiopathic pulmonary fibrosis. Approximately 400 patients at approximately 70 centers will be randomly assigned (2:2:1) to receive either 2403 milligrams (mg) of pirfenidone, placebo equivalent, or 1197 mg of pirfenidone administered in divided doses three times per day (TID) with food. Patients will be randomized by geographic region.

Patients will receive blinded study treatment from the time of randomization until the last patient randomized has been treated for 72 weeks. A Data Monitoring Committee (DMC) will periodically review safety and efficacy data to ensure patient safety.

After week 72, patients who meet the Progression of Disease (POD) definition, which is a ≥ 10% absolute decrease in percent predicted FVC or a ≥ 15% absolute decrease in percent predicted carbon monoxide diffusing capacity (DLco), will be eligible to receive permitted IPF therapies in addition to their blinded study drug. Permitted IPF therapies include corticosteroids, azathioprine, cyclophosphamide and N-acetyl-cysteine (with restrictions). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Fibrosis
Idiopathic Interstitial Pneumonias
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis

Clinical Trial Details

NCT number	NCT00287716
Study type	Interventional
Source	InterMune
Contact
Status	Completed
Phase	Phase 3
Start date	June 2006
Completion date	November 2008

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05984992` - The First-in-human Study of SRN-001 in Healthy Participants	Phase 1
Active, not recruiting	`NCT04312594` - Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis	Phase 2
Recruiting	`NCT03865927` - GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis	Phase 2
Completed	`NCT03979430` - Early Detection of Acute Exacerbation in Patients With Idiopathic Lung Fibrosis - a Pilot Study	N/A
Enrolling by invitation	`NCT04905693` - Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis	Phase 3
Not yet recruiting	`NCT06241560` - A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood	Phase 2
Terminated	`NCT04419558` - Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)	Phase 3
Completed	`NCT03725852` - A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF)	Phase 2
Terminated	`NCT03573505` - An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis	Phase 2
Recruiting	`NCT04148157` - Quality of Life in IPF - Patient and Physician Perceptions
Completed	`NCT03222648` - Structured Exercise Training Programme in Idiopathic Pulmonary Fibrosis	N/A
Not yet recruiting	`NCT06422884` - A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial)	Phase 2
Completed	`NCT02257177` - RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients	Phase 1/Phase 2
Completed	`NCT02268981` - Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)	N/A
Withdrawn	`NCT01524068` - A MultiCenter Study of Combined PEX, Rituximab, and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations	Phase 2
Enrolling by invitation	`NCT01382368` - Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients	Phase 4
Completed	`NCT01199887` - Trial Of IW001 in Patients With Idiopathic Pulmonary Fibrosis	Phase 1
Completed	`NCT01110694` - Prospective Observation of Fibrosis in the Lung Clinical Endpoints Study
Active, not recruiting	`NCT02951416` - Clinical Course of Interstitial Lung Diseases: European IPF Registry and Biobank
Terminated	`NCT00981747` - Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis	Phase 2/Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms