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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,058
Pirfenidone, 2403 mg/d, administered as 801-mg doses, three times daily.
Genentech, Inc.
South San Francisco, California, United States
Percentage of Participants With Adverse Events
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.
Time frame: 7.5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.