Pirfenidone for the Treatment of Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis (PF/IPF) - Full Text View

Sponsor:	InterMune
Information provided by:	InterMune
ClinicalTrials.gov Identifier:	NCT00080223

Purpose

To assess the long-term safety and efficacy of oral pirfenidone in doses of up to 40 mg/kg/d in a limited number of patients with pulmonary fibrosis/idiopathic pulmonary fibrosis (PF/IPF)

Condition	Intervention	Phase
Idiopathic Pulmonary Fibrosis Pulmonary Fibrosis	Drug: Pirfenidone	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label, Phase 2 Study of the Safety and Efficacy of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:

MedlinePlus related topics: Pulmonary Fibrosis

U.S. FDA Resources

Further study details as provided by InterMune:

Primary Outcome Measures:

Adverse events, clinical lab tests, directed physical exams [ Time Frame: Assessments are at 6 month intervals up to approximately 8 years ] [ Designated as safety issue: Yes ]
FVC, DLco,resting SpO2, oxygen utilization, acute IPF exacerbations, survival time [ Time Frame: Assessments are at 6 month intervals up to approximately 8 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	August 2003
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pirfenidone up to 3600 mg/day of pirfenidone given orally, with a target dose of 2403 mg/day, administered in divided doses three times daily with food, for the duration of the study	Drug: Pirfenidone up to 3600 mg/day of pirfenidone given orally, with a target dose of 2403 mg/day, administered in divided doses three times daily with food, for the duration of the study

Detailed Description:

This study has been designed as a rollover study to collectively include safety and efficacy 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.

Eligibility

Ages Eligible for Study:	40 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

General 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 NORD, patients with IPF must have a percent predicted FVC of ≥50%, and percent predicted 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:
Open or VATS lung biopsy showing definite or probable UIP
Transbronchial biopsy showing no features to support an alternative diagnosis
Bronchoalveolar lavage (BAL) showing no features to support an alternative diagnosis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080223

Locations

United States, California
InterMune, Inc.
Brisbane, California, United States, 94005

Sponsors and Collaborators

InterMune

Investigators

Study Director:

Bill Bradford, MD, PhD

InterMune

More Information

No publications provided

Responsible Party:	Bill Bradford, MD, PhD, InterMune, Inc.
ClinicalTrials.gov Identifier:	NCT00080223 History of Changes
Other Study ID Numbers:	PIPF-002
Study First Received:	March 24, 2004
Last Updated:	April 11, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by InterMune:

pulmonary fibrosis
respiratory diseases

Additional relevant MeSH terms:

Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Pirfenidone
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 21, 2012