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

Genentech

Status and phase

Completed

Phase 3

Conditions

Idiopathic Pulmonary Fibrosis

Treatments

Drug: pirfenidone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00662038

GA29960 (Other Identifier)

PIPF-012

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,058 patients

Sex

All

Ages

40 to 84 years old

Volunteers

No Healthy Volunteers

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