NCT00662038

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,058 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 40 Years – 84 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	pirfenidone	Pirfenidone, 2403 mg/d, administered as 801-mg doses, three times daily.

Timeline

• Start date: 2008-08-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2008-04-21
• Last updated: 2017-03-29
• Results posted: 2017-03-29

Locations

1 site across 1 country: United States