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Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF) (PIPF-012)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00662038
Recruitment Status : Completed
First Posted : April 21, 2008
Results First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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Brief Summary:
This is an open-label, multi-center, extension study for patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone. The purpose of this study is to obtain additional safety data for pirfenidone 2403 mg/day in patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: pirfenidone Phase 3

Detailed Description:

This is an open-label, multi-center, extension study for patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone. Eligible patients must complete the final visit for their qualifying study, have not permanently discontinued study drug in their qualifying study, and meet all of the eligibility criteria noted in this protocol.

Since data from the qualifying study may remain blinded during patient enrollment in PIPF-012, all patients will be treated as if they were taking placebo in their qualifying study. At the start of PIPF-012 participation, each patient will escalate the dose of pirfenidone.

The duration of treatment for each patient will vary and will continue until pirfenidone is commercially or otherwise available in his/her geographic region or the study is terminated by the sponsor for reasons outlined in the protocol.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1058 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Study Start Date : August 2008
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Pirfenidone

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
pirfenidone
 Drug: pirfenidone
Pirfenidone, 2403 mg/d, administered as 801-mg doses, three times daily.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Adverse Events [ Time Frame: 7.5 years ]
    An adverse event defined as any unfavorable, harmful, or pathologic change in a research participant administered a pharmaceutical study treatment as indicated by physical signs, symptoms, and/or clinically significant laboratory abnormalities that occurred during the treatment and the post-treatment period, regardless of suspected cause.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completes the qualifying clinical study final visit
  • In the opinion of the principal investigator (PI), has been generally compliant with study requirements during the qualifying study, or must be considered eligible to enroll in PIPF-012 by the InterMune medical monitor
  • Is able to provide informed consent and comply with the requirements of the study

Exclusion Criteria:

  • Is pregnant or lactating
  • Has known hypersensitivity to any of the components of the study drug
  • Starts participation in another interventional clinical trial between the end of participation in the qualifying InterMune clinical trial and entry into PIPF-012
  • Receives concomitant and/or excluded medications as defined in the protocol
  • Permanently discontinues study drug during the qualifying study for any reason before study completion
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00662038


Locations
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United States, California
Genentech, Inc.
South San Francisco, California, United States, 94080-4990
Sponsors and Collaborators
Genentech, Inc.
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Genentech, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00662038    
Other Study ID Numbers: PIPF-012
GA29960 ( Other Identifier: Genentech )
First Posted: April 21, 2008    Key Record Dates
Results First Posted: March 29, 2017
Last Update Posted: March 29, 2017
Last Verified: February 2017
Keywords provided by Genentech, Inc.:
idiopathic
pulmonary
fibrosis
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Pirfenidone
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents