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

NCT ID: NCT00080223

Last Updated: 2017-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2015-04-30

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).

Detailed Description

This study has been designed as a rollover study to collectively include safety data from various previous studies.

In addition, InterMune has also initiated an Early Access Program to make pirfenidone available to a limited number of patients with idiopathic pulmonary fibrosis in the United States. This program is also being conducted under this protocol. Registration of patients with documented IPF has been closed as of October 2005.

Conditions

Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Pirfenidone

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

Group Type: EXPERIMENTAL

Pirfenidone

Intervention Type: 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

Interventions

Pirfenidone

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Phoenix, Arizona, United States

Pomona, California, United States

San Jose, California, United States

New Haven, Connecticut, United States

Sarasota, Florida, United States

Atlanta, Georgia, United States

Kailua, Hawaii, United States

Lahaina, Hawaii, United States

Nampa, Idaho, United States

Elk Grove Village, Illinois, United States

Boston, Massachusetts, United States

West Roxbury, Massachusetts, United States

St Louis, Missouri, United States

Huntington Station, New York, United States

New York, New York, United States

New York, New York, United States

Rochester, New York, United States

Worthington, Ohio, United States

Portland, Oregon, United States

Portland, Oregon, United States

Lancaster, Pennsylvania, United States

Dallas, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States

Provo, Utah, United States

Annandale, Virginia, United States

Bremerton, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32026243 (View on PubMed)

Other Identifiers

GA29989

Identifier Type: OTHER

Identifier Source: secondary_id

PIPF-002

Identifier Type: -

Identifier Source: org_study_id