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

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ClinicalTrials.gov Identifier: NCT00287716

Recruitment Status : Completed

First Posted : February 7, 2006

Results First Posted : June 13, 2011

Last Update Posted : May 22, 2017

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Genentech, Inc.

Tracking Information

First Submitted Date ^ICMJE

February 6, 2006

First Posted Date ^ICMJE

February 7, 2006

Results First Submitted Date ^ICMJE

June 2, 2010

Results First Posted Date ^ICMJE

June 13, 2011

Last Update Posted Date

May 22, 2017

Actual Study Start Date ^ICMJE

July 14, 2006

Actual Primary Completion Date

November 10, 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Absolute Change in Percent Predicted Forced Vital Capacity (FVC) [ Time Frame: From baseline up to 72 weeks ]

Mean Change in Percent Predicted Forced Vital Capacity (FVC) as measured from baseline to week 72.

Original Primary Outcome Measures ^ICMJE

The primary efficacy outcome variable is the change in FVC from baseline to Week 60.

Change History

Current Secondary Outcome Measures ^ICMJE

Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity (FVC) [ Time Frame: baseline up to 72 weeks ]
Based on the change in baseline percent predicted FVC at week 72, patients were assigned to 1 of 5 categories: mild decline (<10% but >=0% decline), moderate decline (<20% but >=10% decline), severe decline (>=20% decline), mild improvement (>0% but <10% improvement), or moderate improvement (>=10% improvement). Those who died or had a lung transplant before Week 72 were included in the severe decline category. The results indicate the number of patients who experienced a Categorical Change in Percent Predicted Forced Vital Capacity.
Progression-free Survival (PFS) [ Time Frame: Baseline to Week 72 ]
Progression is defined as the first occurrence of a 10% absolute decline from baseline in percent predicted Forced Vital Capacity, a 15% absolute decline from baseline in percent predicted hemoglobin(Hgb)-corrected carbon monoxide diffusing capacity (DLco), or, death.
Change in Six-Minute Walk Test (6MWT)Distance [ Time Frame: Baseline to Week 72 ]
The change from Baseline to week 72 in distance walked during the 6-Minute Walk Test as measured in meters (m).
Change in Worst Oxygen Saturation by Pulse Oximetry (SpO2) Measurement Observed During the 6-Minute Walk Test [ Time Frame: Baseline to Week 72 ]
The change from baseline to week 72 in worst oxygen saturation during the 6-Minute Walk Test as measure by Pulse Oximetry (SpO2) Level is calculated as the simple difference between baseline SpO2 measurements and week 72 SpO2 measurements.
Change in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs [ Time Frame: Baseline to Week 72 ]
Change in Dyspnea Score [ Time Frame: Baseline to Week 72 ]
The mean change from baseline to week 72 in Dyspnea score was measured by the University of San Diego Shortness of Breath Questionnaire (UCSD SOBQ). The SOBQ is used to assess shortness of breath with various activities of daily living (for example, brushing ones teeth or mowing the lawn). Patients rated the severity of their shortness of breath experienced on an average day during the past week on a 6 point scale (0 to 5), with 0 = not at all breathless, 4= severely breathless and 5 = Maximally or unable to do because of breathlessness.
Worsening of Idiopathic Pulmonary Fibrosis (IPF) [ Time Frame: Time to acute IPF exacerbation, IPF-related death, lung transplant or respiratory hospitalization, whichever comes first. ]
Worsening of IPF was defined by the occurrence of any of the following events: Acute IPF exacerbation, IPF-related death, Lung transplantation, or Respiratory hospitalization.

Original Secondary Outcome Measures ^ICMJE

1.Composite outcomes of important IPF-related events
2.Progression-free survival
3.Change in percent FVC from baseline to Week 60
4.Change in Shortness-Of-Breath from baseline to Week 60
5.Change in Hb-corrected DLCO/TLCO from baseline to Week 60
6.Change in oxygen saturation during the 6MWT from baseline to Week 60
7.Change in the 6MWT from baseline to Week 60

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized, Double-Blind, Placebo Controlled, Phase 3, Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

Brief 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.

Detailed 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 Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Idiopathic Pulmonary Fibrosis

Intervention ^ICMJE

Drug: Pirfenidone
1197 or 2403 mg/day given orally, and administered in divided doses three times daily with food, for the duration of the study.
Drug: Placebo
Placebo equivalent, given orally, and administered in divided doses three times daily with food, for the duration of the study.

Study Arms ^ICMJE

Active Comparator: 2403 mg/day pirfenidone
Active arm 1, 2403 mg/day pirfenidone dose group.

Intervention: Drug: Pirfenidone
Active Comparator: 1197 mg/day pirfenidone
Active arm 2, 1197 mg/day pirfenidone.

Intervention: Drug: Pirfenidone
Placebo Comparator: placebo
Placebo equivalent.

Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

435

Original Enrollment ^ICMJE

325

Actual Study Completion Date ^ICMJE

November 10, 2008

Actual Primary Completion Date

November 10, 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Primary Inclusion criteria:

diagnosis of idiopathic pulmonary fibrosis
40 to 80 years of age
Forced Vital Capacity greater than or equal to 50% predicted value
Carbon monoxide diffusing capacity greater than or equal to 35% predicted value
either Forced Vital Capacity or Carbon monoxide diffusing capacity less than or equal to 90% predicted value
no improvement in past year
able to walk 150 meters in 6 minutes and maintain saturation greater than or equal to 83% while on no more than 6 liters per minute (L/min) supplemental oxygen

Primary Exclusion criteria:

unable to undergo pulmonary function testing
evidence of significant obstructive lung disease or airway hyper-responsiveness
in opinion of investigator patient is expected to need and be eligible for a lung transplant within 72 weeks after randomization
active infection
liver disease
cancer or other medical condition likely to result in death within 2 years
diabetes
pregnancy or lactation
substance abuse
personal or family history of long QT (Q wave,T wave) syndrome
other IPF treatment
unable to take study medication
withdrawal from other IPF trials

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

40 Years to 80 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00287716

Other Study ID Numbers ^ICMJE

PIPF-004
Capacity 2

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

Genentech, Inc.

Original Responsible Party

Not Provided

Current Study Sponsor ^ICMJE

Genentech, Inc.

Original Study Sponsor ^ICMJE

InterMune

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Genentech, Inc.

Verification Date

April 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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