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Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF) (PIPF-012)
This study is ongoing, but not recruiting participants.
First Received: April 17, 2008   Last Updated: January 15, 2009   History of Changes
Sponsored by: InterMune
Information provided by: InterMune
ClinicalTrials.gov Identifier: NCT00662038
  Purpose

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
Idiopathic Pulmonary Fibrosis
Drug: pirfenidone
Phase III

MedlinePlus related topics: Pulmonary Fibrosis
Drug Information available for: Pirfenidone
U.S. FDA Resources
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

Further study details as provided by InterMune:

Primary Outcome Measures:
  • Adverse events (AEs) (including acute IPF exacerbation and pneumonia), clinical lab tests, electrocardiograms, early discontinuations, death. [ Time Frame: Week 1, 2, 4, 6, 12, and every 12 weeks thereafter until the end of the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent predicted forced vital capacity (FVC, Percent predicted hemoglobin (HB)-corrected Carbon monoxide diffusing capacity (DLCO) [ Time Frame: Weeks 2, 4, 6, 12, and every 12 weeks thereafter until the end of the study ] [ Designated as safety issue: No ]

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
A: Experimental
pirfenidone
Drug: pirfenidone
2403 mg/d of pirfenidone administered in 3 capsules TID

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completes the CAPACITY studies Final Follow-Up Visit.
  • In the opinion of the principal investigator (PI), has been at least 80% compliant with taking the study drug at the time of the CAPACITY Treatment Completion Visit, or must obtain permission from the InterMune medical monitor
  • Is able to provide informed consent and comply with the requirements of the study

Exclusion Criteria:

  • Pregnant or lactating women
  • Known hypersensitivity to any of the components of the study drug
  • In the opinion of the PI, is not a suitable candidate for study participation
  • Participates in another interventional clinical trial between the end of participation in either PIPF-004 or PIPF-006 and planned entry into this trial
  • Receives concomitant medications defined in the protocol
  • Permanently discontinues study drug during the PIPF-004 or PIPF-006 studies for any reason
  • Does not meet liver function test criteria as defined in protocol
  • Has an ECG from the CAPACITY Study Treatment Completion Visit or from the PIPF-012 Day 1 Visit with a heart-rate-corrected (using Bazett's formula) QT interval (QTcB) of >500 ms
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662038

Locations
United States, California
InterMune, Inc.
Brisbane, California, United States, 94005
Sponsors and Collaborators
InterMune
Investigators
Study Director: Javier Szwarcberg, MD, MPH InterMune
  More Information

No publications provided

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

Keywords provided by InterMune:
idiopathic
pulmonary
fibrosis

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009