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Sponsored by: |
InterMune |
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Information provided by: | InterMune |
ClinicalTrials.gov Identifier: | NCT00662038 |
This is an open-label, multicenter, extension study for patients with IPF who complete the CAPACITY Trials (PIPF-004 and PIPF 006). The purpose of this study is to obtain additional safety data for pirfenidone in patients with IPF who complete either Study PIPF-004 or PIPF-006.
Condition | Intervention | Phase |
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Idiopathic Pulmonary Fibrosis |
Drug: pirfenidone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Extension Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies |
Enrollment: | 603 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
pirfenidone
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Drug: pirfenidone
2403 mg/d of pirfenidone administered in 3 capsules TID
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This is an open-label, multicenter, extension study for patients with IPF who complete the CAPACITY Trials (PIPF-004 and PIPF 006). Eligible patients must complete the Final Follow-Up Visit for the CAPACITY studies and meet all of the eligibility criteria noted in the protocol. Only the sites that participate in the CAPACITY studies will be eligible to participate in this study.
The data from the CAPACITY Trials will remain blinded during the PIPF-012 enrollment period. Therefore, all patients will be treated as if they were taking placebo in the CAPACITY studies, and at the start of PIPF-012 will escalate their dose of pirfenidone.
The duration of treatment for each patient will be variable and will continue until pirfenidone is commercially available in a geographic region, the study is terminated by the sponsor for reasons outlined in the protocol, or approximately 2.5 years have elapsed since the patient's first dose of pirfenidone, whichever is shortest.
Ages Eligible for Study: | 40 Years to 84 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | InterMune, Inc. ( Javier Szwarcberg/Senior Director, Clinical Science ) |
Study ID Numbers: | PIPF-012, No secondary ID |
Study First Received: | April 17, 2008 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00662038 History of Changes |
Health Authority: | United States: Food and Drug Administration; Belgium: Federal Agency for Medicinal Products and Health Products; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Ireland: Irish Medicines Board; Italy: Ministry of Health; Mexico: Ministry of Health; Poland: Ministry of Health; Spain: Spanish Agency of Medicines; Switzerland: Swissmedic; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
idiopathic pulmonary fibrosis |
Anti-Inflammatory Agents Lung Diseases, Interstitial Fibrosis Pulmonary Fibrosis Pirfenidone Respiratory Tract Diseases Analgesics, Non-Narcotic |
Lung Diseases Idiopathic Pulmonary Fibrosis Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents |
Anti-Inflammatory Agents Lung Diseases, Interstitial Antineoplastic Agents Fibrosis Physiological Effects of Drugs Pulmonary Fibrosis Pharmacologic Actions Pirfenidone Pathologic Processes Respiratory Tract Diseases |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Lung Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |