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Sponsored by: |
InterMune |
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Information provided by: | InterMune |
ClinicalTrials.gov Identifier: | NCT00080223 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Phase 2 Study of the Safety and Efficacy of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis |
Estimated Enrollment: | 90 |
Study Start Date: | August 2003 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 40 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
General Inclusion Criteria:
Roll-Over Criteria:
Criteria for Early Access Program patients:
Responsible Party: | InterMune, Inc. ( Javier Szwarcberg, MD, MPH / Senior Director ) |
Study ID Numbers: | PIPF-002 |
Study First Received: | March 24, 2004 |
Last Updated: | March 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00080223 |
Health Authority: | United States: Food and Drug Administration |
pulmonary fibrosis respiratory diseases |
Pirfenidone Lung Diseases, Interstitial Respiratory Tract Diseases Fibrosis |
Hamman-Rich syndrome Lung Diseases Respiration Disorders Pulmonary Fibrosis |
Anti-Inflammatory Agents Antineoplastic Agents Physiological Effects of Drugs Pharmacologic Actions Pathologic Processes Sensory System Agents Analgesics, Non-Narcotic |
Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |