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

Idiopathic Pulmonary Fibrosis Clinical Trial

— PIPF-012  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00662038
• Other study ID #: PIPF-012
• Secondary ID: GA29960
• Status: Completed
• Phase: Phase 3
• First received: April 17, 2008
• Last updated: July 13, 2016
• Start date: August 2008
• Est. completion date: February 2016

Study information

• Verified date: July 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaAustralia: Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1058
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 84 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• pirfenidone
2403 mg/day of pirfenidone administered in divided doses 3 times daily

Locations

Country	Name	City	State
United States	Genentech, Inc.	South San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Genentech, Inc.	Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events (AEs), clinical lab tests, electrocardiograms, early discontinuations, death.		Week 1, 2, 4, 8, 12, 16, 20, 24 and every 12 weeks thereafter until the end of the study	Yes