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Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00287729
Recruitment Status : Completed
First Posted : February 7, 2006
Results First Posted : June 13, 2011
Last Update Posted : April 17, 2017
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 April 17, 2017
Study Start Date  ICMJE April 2006
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2011)
Absolute Change in Percent Predicted Forced Vital Capacity(FVC) [ Time Frame: Baseline to week 72 ]
Mean Change in Percent Predicted Forced Vital Capacity (FVC) as measured from baseline to week 72. It is calculated as the simple difference between baseline Percent Predicted FVC measurements and week 72 Percent Predicted FVC measurements.
Original Primary Outcome Measures  ICMJE
 (submitted: February 6, 2006)
The primary outcome variable is the change in FVC.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2011)
  • Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity [ Time Frame: Baseline to week 72 ]
    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 experience Categorical Change in Percent Predicted Forced Vital Capacity.
  • Progression-free Survival [ 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 the 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. This measure was calculated as the simple difference between baseline distanced walked over 6 minutes and week 72 distance walked over 6 minutes 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. It 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 ]
    The change from baseline to week 72 in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs. It is calculated as the simple difference between baseline DLco measurements and week 72 DLco measurements.
  • 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 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
 (submitted: February 6, 2006)
  • 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 HRCT assessment from baseline to Week 60
  • 8.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 Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Official Title  ICMJE A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Brief Summary The purposes of this study are to assess the efficacy of treatment with pirfenidone 2403 milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis (IPF)and to assess the safety of treatment with pirfenidone 2403 milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis.
Detailed Description

This is a Phase 3, randomized, double-blind, placebo-controlled, safety and efficacy study of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF). Approximately 320 patients at approximately 50 centers will be randomly assigned (1:1) to receive pirfenidone 2403 milligrams or placebo equivalent administered in divided doses three times per day (TID) with food. The primary outcome variable will be the absolute change in percent predicted Forced Vital Capacity from Baseline to Week 72. 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 Forced Vital Capacity or a ≥ 15% absolute decrease in percent predicted carbon monoxide diffusing capacity (DLco), will be eligible to receive permitted idiopathic pulmonary fibrosis therapies in addition to their blinded study drug. Permitted idiopathic pulmonary 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
    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
    2403 mg/day pirfenidone dose group.
    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
 (submitted: January 15, 2009)
344
Original Enrollment  ICMJE
 (submitted: February 6, 2006)
260
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 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 ≥ 50% predicted value
  • carbon monoxide diffusing capacity (DLco) ≥ 35% predicted value
  • either Forced Vital Capacity or carbon monoxide diffusing capacity (DLco) ≤ 90% predicted value
  • no improvement in past year
  • able to walk 150 meters in 6 minutes and maintain saturation ≥ 83% while on no more than 6 liters per minute supplemental oxygen

Primary Exclusion criteria:

  • unable to undergo pulmonary function testing
  • evidence of significant obstructive lung disease or airway hyper-responsiveness
  • in the clinical opinion of the investigator, the patient is expected to need and be eligible for a lung transplant within 72 weeks of 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 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 No
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 NCT00287729
Other Study ID Numbers  ICMJE PIPF-006
Capacity 1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Genentech, Inc.
Verification Date March 2017

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