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

• 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: Genentech, Inc.
• Collaborator: Hoffmann-La Roche
• Information provided by (Responsible Party): Genentech, Inc.

Tracking Information

• First Submitted Date: April 17, 2008
• First Posted Date: April 21, 2008
• Results First Submitted Date: February 9, 2017
• Results First Posted Date: March 29, 2017
• Last Update Posted Date: March 29, 2017
• Study Start Date: August 2008
• Actual Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (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: Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Idiopathic Pulmonary Fibrosis

Intervention

Drug: pirfenidone

Pirfenidone, 2403 mg/d, administered as 801-mg doses, three times daily.

Study Arms

Experimental: Treatment

pirfenidone

Intervention: Drug: pirfenidone

Publications *

• Maher TM, Lancaster LH, Jouneau S, Morrison L, Lederer DJ, Molina-Molina M, Bendstrup E, Kirchgaessler KU, Gilberg F, Axmann J, Petzinger U, Noble PW. Pirfenidone Treatment in Individuals with Idiopathic Pulmonary Fibrosis: Impact of Timing of Treatment Initiation. Ann Am Thorac Soc. 2019 Jul;16(7):927-930. doi: 10.1513/AnnalsATS.201810-720RL. No abstract available.
• Costabel U, Albera C, Lancaster LH, Lin CY, Hormel P, Hulter HN, Noble PW. An Open-Label Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (RECAP). Respiration. 2017;94(5):408-415. doi: 10.1159/000479976. Epub 2017 Sep 13.
• Lancaster L, Albera C, Bradford WZ, Costabel U, du Bois RM, Fagan EA, Fishman RS, Glaspole I, Glassberg MK, King TE Jr, Lederer DJ, Lin Z, Nathan SD, Pereira CA, Swigris JJ, Valeyre D, Noble PW. Safety of pirfenidone in patients with idiopathic pulmonary fibrosis: integrated analysis of cumulative data from 5 clinical trials. BMJ Open Respir Res. 2016 Jan 12;3(1):e000105. doi: 10.1136/bmjresp-2015-000105. eCollection 2016.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 13, 2016): 1058
• Original Estimated Enrollment (submitted: April 18, 2008): 750
• Actual Study Completion Date: February 2016
• Actual Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 84 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00662038
• Other Study ID Numbers: PIPF-012; GA29960 ( Other Identifier: Genentech )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Genentech, Inc.
• Original Responsible Party: Javier Szwarcberg/Senior Director, Clinical Science, InterMune, Inc.
• Current Study Sponsor: Genentech, Inc.
• Original Study Sponsor: InterMune
• Collaborators: Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Genentech, Inc.

• PRS Account: Genentech, Inc.
• Verification Date: February 2017