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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.

Tracking Information
First Submitted Date  ICMJE April 17, 2008
First Posted Date  ICMJE April 21, 2008
Results First Submitted Date  ICMJE February 9, 2017
Results First Posted Date  ICMJE March 29, 2017
Last Update Posted Date March 29, 2017
Study Start Date  ICMJE August 2008
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2008)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Official Title  ICMJE An Open-Label Extension Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Pulmonary Fibrosis
Intervention  ICMJE Drug: pirfenidone
Pirfenidone, 2403 mg/d, administered as 801-mg doses, three times daily.
Study Arms  ICMJE Experimental: Treatment
pirfenidone
Intervention: Drug: pirfenidone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2016)
1058
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2008)
750
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00662038
Other Study ID Numbers  ICMJE PIPF-012
GA29960 ( Other Identifier: Genentech )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Hoffmann-La Roche
Investigators  ICMJE
Study Director: Clinical Trials Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP