Expanded Access Pirfenidone

Overview

Status: Not yet recruiting
Keywords: IPF , Idiopathic Pulmonary Fibrosis , pirfenidone , ILD
IRB Number: 00073161
Specialty: Pulmonary
Sub Specialties: Pulmonary Fibrosis

Brief Summary

 The objective of this treatment protocol is to provide access to pirfenidone to patients in the US with IPF

Principal Investigator: Mary Scholand
Department: Pulmonary
Co Investigator:

Contact Information

Name:Richard Mittan
Phone: 801-581-5811
Email: richard.mittan@hsc.utah.edu

Inclusion Criteria

1. Clinical and radiographical diagnosis of IPF including the presence of usul interstitial pneumonia (UIP) pattern or possible UIP pattern on historical HRCT

2. %FVC>= 50% and %DLco >=30% based either on historical pulmonary function tests obtained in the 30 days prior to screening or on tests obtained during screening.

3. Abe to understand the importance of adherence to program treatment (pirfenidone) and protocol, and willing to follow all program requirments, including the concomitant medication restrictions, throughout the program

3. Able to understand and sign a written informed consent form. 

4. Greater than 18 years of age

Exclusion Criteria

Is receiving an investigational agend (defined as any drug that has not been approved for marketing for any indication in the US); prior use of pirfenidone is permitted.

2.  Has received fluvoxamine therapy <=29 days prior to the first dose of program treatment (pirfenidone)in PIPF-031, or is unable or unwilling to avoid fluvoxamine for the duration of the program. 

3. Has any known contraindication for the use of pirfenidone, specifically;

-Hypersensitivity to the active substance or to any of the drug product excipients

-Severe hepatic impairment including end stage liver disease

-Severe renal impairment (CrCl<30 mL/min) including end stage renal disease requiring dialysis

4. History of cigarette smoking within 3 months prior to the completion of screening or is unwilling to avoid tobacco products throughout program. 

5. Known explanation for interstitial lung disease other than IPF, including but not limited to radiation, drug toxicity, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, human immunodeficiency virus (HIV) infection, viral hepatitis, and cancer.

6. History of clinically significant environmental exposure known to cause pulmonary fibrosis (PF), including but not limited to drugs (such as amiodarone), asbestos, beryllium, radiation,a dn domestic birds.

7.  Preganancy or lactiation.  Women of childbearing capacity are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective contraception by practicing abstinence or by using at least two methods of birth control from the date of consent through the end of participation in the program.  If abstinence is not practiced, one of the two methods of brith control should be a hormonal contraceptive (e.g. oral contraceptive and a spremicide).