Expanded Access Program (EAP): Allow Patients in the US With Idiopathic Pulmonary Fibrosis Access to Pirfenidone

July 9, 2015 updated by: Genentech, Inc.

A Treatment Protocol to Allow Patients in the US With Idiopathic Pulmonary Fibrosis Access to Pirfenidone

This is an open label multi-center program to allow patients in the US with IPF access to treatment with pirfenidone.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Study Type

Expanded Access

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. Clinical and radiographic diagnosis of IPF including the presence of usual interstitial pneumonia (UIP) pattern or possible UIP pattern on historical HRCT (ATS 2011).

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

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

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from the program:

  1. Is receiving an investigational agent (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 ≤ 28 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, and domestic birds.
  7. Pregnancy or lactation. 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 birth control should be a hormonal contraceptive (e.g., oral contraceptive and a spermicide).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 15, 2014

First Submitted That Met QC Criteria

May 15, 2014

First Posted (ESTIMATE)

May 19, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

July 13, 2015

Last Update Submitted That Met QC Criteria

July 9, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIPF-031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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