Pirfenidone for the Treatment of Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis (PF/IPF)
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First Received Date ICMJE | March 24, 2004 | ||||
Last Updated Date | April 11, 2011 | ||||
Start Date ICMJE | August 2003 | ||||
Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00080223 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
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Current Other Outcome Measures ICMJE | |||||
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Descriptive Information | |||||
Brief Title ICMJE | Pirfenidone for the Treatment of Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis (PF/IPF) | ||||
Official Title ICMJE | An Open-Label, Phase 2 Study of the Safety and Efficacy of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis | ||||
Brief Summary | 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) |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | 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 |
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Study Arm (s) | 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
Intervention: Drug: Pirfenidone |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 90 | ||||
Estimated Completion Date | December 2014 | ||||
Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | General Inclusion Criteria:
Roll-Over Criteria:
Criteria for Early Access Program patients:
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Gender | Both | ||||
Ages | 40 Years to 85 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00080223 | ||||
Other Study ID Numbers ICMJE | PIPF-002 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Bill Bradford, MD, PhD, InterMune, Inc. | ||||
Study Sponsor ICMJE | InterMune | ||||
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Investigators ICMJE |
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Information Provided By | InterMune | ||||
Verification Date | April 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |