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
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Pulmonary Fibrosis||Drug: pirfenidone||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||1058 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
U.S. FDA Resources
Pirfenidone, 2403 mg/d, administered as 801-mg doses, three times daily.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00662038
|United States, California|
|South San Francisco, California, United States, 94080-4990|
|Study Director:||Clinical Trials||Genentech, Inc.|