Safety Study of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis

NCT00080223 | Completed Phase 2 Results

• 2 other identifiers: PIPF-002GA29989
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 27

Brief Summary

To assess the safety of treatment with pirfenidone (up to 3600 mg/d) in patients with pulmonary fibrosis/idiopathic pulmonary fibrosis (PF/IPF).

Conditions

Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis

Keywords

pulmonary fibrosis; respiratory diseases

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Treatment-Emergent Adverse Event (AE), Serious AE (SAE), Severe AE, Life-threatening AE, Death or Discontinuation Because of an AE

  An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were classified as severe (Grade 3) in following cases: marked limitation in activity; some assistance usually required; medical intervention/ therapy required, hospitalization possible. Treatment-emergent AEs were those occurring on or after the first dosing day and up to 28 days after discontinuation of study treatment, and those occurring before treatment that worsened after the first study dose. AE included serious as well as non-serious AEs.

  Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)

Secondary Outcomes (4)

• Percent Predicted Forced Vital Capacity (FVC)

  Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480

• Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)

  Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480

• Resting Oxygen Saturation by Pulse Oximetry (SpO2)

  Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480

• Overall Survival

  First dosing of study treatment until death (up to 604 weeks)

Study Arms (1)

Pirfenidone

EXPERIMENTAL

up to 3600 mg/day of pirfenidone given orally administered in divided doses three times daily with food, for the duration of the study

Drug: Pirfenidone

Interventions

Pirfenidone DRUG

up to 3600 mg/day of pirfenidone given orally administered in divided doses three times daily with food, for the duration of the study

Pirfenidone

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and sign an informed consent form
• Understand the importance of adherence to study treatment and the study protocol, including concomitant medication restrictions, throughout the study period
• Patients must be willing to travel to an approved regional center for all study-related visits
• Roll-Over Criteria:
• Entry into study through rollover has been completed
• Criteria for Early Access Program patients:
• Clinical symptoms consistent with IPF ≥3 months duration
• Age 40 - 85, inclusive
• At the time of registration with National Organization for Rare Disorders (NORD), patients with IPF must have a percent predicted forced vital capacity (FVC) of ≥50%, and percent predicted carbon monoxide diffusing capacity (DLCO) of ≥35%
• At the time of enrollment in PIPF-002, (screening/baseline visit) percent predicted FVC must be ≥45%, and percent predicted DLCO must be ≥30%
• High-resolution computed tomographic scan (HRCT) showing definite IPF. For patients with surgical lung biopsy showing definite or probable usual interstitial pneumonia (UIP), the HRCT criterion of probable IPF is sufficient
• For patients aged \<50 years: open or video-assisted thoracoscopic (VATS) lung biopsy showing definite or probable UIP. In addition, no features supporting an alternative diagnosis on transbronchial biopsy or bronchoalveolar lavage if performed
• For patients aged ≥50 years: at least one of the following diagnostic findings as well as the absence of any features on specimens resulting from any of these procedures that support an alternative diagnosis: 1) Open or VATS lung biopsy showing definite or probable UIP; 2) Transbronchial biopsy showing no features to support an alternative diagnosis; 3) Bronchoalveolar lavage (BAL) showing no features to support an alternative diagnosis

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (27)

Unknown Facility

Phoenix, Arizona, 85006, United States

Location

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Pomona, California, 91767, United States

Location

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San Jose, California, 95119, United States

Location

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New Haven, Connecticut, 06520, United States

Location

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Sarasota, Florida, 34239, United States

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Atlanta, Georgia, 30322, United States

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Kailua, Hawaii, 96734, United States

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Lahaina, Hawaii, 96761, United States

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Nampa, Idaho, 83686, United States

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Elk Grove Village, Illinois, 60007, United States

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Boston, Massachusetts, 02118, United States

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West Roxbury, Massachusetts, 02132, United States

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St Louis, Missouri, 63110, United States

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Huntington Station, New York, 11746, United States

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New York, New York, 10016, United States

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New York, New York, 10029-6574, United States

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Rochester, New York, 14620, United States

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Worthington, Ohio, 43085, United States

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Portland, Oregon, 97220, United States

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Portland, Oregon, 97227, United States

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Lancaster, Pennsylvania, 17601, United States

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Dallas, Texas, 75390-8503, United States

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Houston, Texas, 77005, United States

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San Antonio, Texas, 78229, United States

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Provo, Utah, 84604, United States

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Annandale, Virginia, 22003, United States

Location

Unknown Facility

Bremerton, Washington, 98310 - 3349, United States

Location

Related Publications (1)

• Gotfried MH, Girod CE, Antin-Ozerkis D, Burgess T, Strombom I, Stauffer JL, Kirchgaessler KU, Padilla ML. An Open-Label, Phase II Study of the Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (PIPF-002). Pulm Ther. 2018 Jun;4(1):59-71. doi: 10.1007/s41030-018-0053-y. Epub 2018 Apr 5.

  PMID: 32026243 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis; Respiratory Tract Diseases

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2004
• First Posted: March 26, 2004
• Study Start: August 31, 2003
• Primary Completion: April 30, 2015
• Study Completion: April 30, 2015
• Last Updated: April 17, 2017
• Results First Posted: March 9, 2016

Record last verified: 2017-03

Locations

US (27)