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.

Study Description

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

• 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

Arms and Interventions

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

Outcome Measures

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

• 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

Locations

United States, California

Genentech, Inc.

South San Francisco, California, United States, 94080-4990

Sponsors and Collaborators

Genentech, Inc.

Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Genentech, Inc.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT00662038
• Other Study ID Numbers: PIPF-012; GA29960 ( Other Identifier: Genentech )
• First Posted: April 21, 2008
• 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:

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