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.
Sponsor:
Information provided by (Responsible Party):
InterMune
ClinicalTrials.gov Identifier:
NCT00662038
First received: April 17, 2008
Last updated: January 30, 2012
Last verified: January 2012

April 17, 2008
January 30, 2012
August 2008
December 2015   (final data collection date for primary outcome measure)
Adverse events (AEs), clinical lab tests, electrocardiograms, early discontinuations, death. [ Time Frame: Week 1, 2, 4, 8, 12, 16, 20, 24 and every 12 weeks thereafter until the end of the study ] [ Designated as safety issue: Yes ]
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 ]
Complete list of historical versions of study NCT00662038 on ClinicalTrials.gov Archive Site
Not Provided
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 ]
Not Provided
Not Provided
 
Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
An Open-Label Extension Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)

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.

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.

Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Idiopathic Pulmonary Fibrosis
Drug: pirfenidone
2403 mg/day of pirfenidone administered in divided doses 3 times daily
Experimental: Treatment
pirfenidone
Intervention: Drug: pirfenidone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3000
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
40 Years to 84 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00662038
PIPF-012, No secondary ID
No
InterMune
InterMune
Not Provided
Study Director: Elizabeth Fagan, MD, FACP InterMune
InterMune
January 2012

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