Idiopathic Pulmonary FibrosisNCT02141087
Expanded Access Program (EAP): Allow Patients in the US With Idiopathic Pulmonary Fibrosis Access to Pirfenidone
A study testing Pirfenidone in people with Idiopathic Pulmonary Fibrosis, run by Genentech, Inc..
Trial summary
This is an open label multi-center program to allow patients in the US with IPF access to treatment with pirfenidone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Pirfenidone
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- A patient who meets any of the following criteria will be excluded from the program:
- 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.
- 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.
- 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
Show all 11Show fewer
- Severe renal impairment (CrCl < 30 mL/min) including end stage renal disease requiring dialysis
- History of cigarette smoking within 3 months prior to the completion of screening or is unwilling to avoid tobacco products throughout program.
- 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.
- 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.
- 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).
About this study
Official title: 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Pirfenidone
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirfenidoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141087
- Sponsor's protocol ID
- PIPF-031
- Status last verified
- Jul 2015
- First submitted
- 15 May 2014
- Last updated
- 13 Jul 2015
- Results posted
- No
Publications
Lancaster L, Morrison L, Auais A, Ding B, Iqbal A, Polman B, Flaherty KR. Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis: Experience from 92 Sites in an Open-Label US Expanded Access Program. Pulm Ther. 2017 Dec;3(2):317-325. doi: 10.1007/s41030-017-0049-z. Epub 2017 Sep 6.
PubMed 32026347
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Treatment Protocol to Allow Patients in the US With Idiopathic Pulmonary Fibrosis Access to Pirfenidone
- ClinicalTrials.gov ID
- NCT02141087
- Acronym / sponsor ID
- PIPF-031
- Conditions
- Idiopathic Pulmonary Fibrosis
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- First posted
- 19 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label multi-center program to allow patients in the US with IPF access to treatment with pirfenidone.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
- 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.
- Has any known contraindication for the use of pirfenidone, specifically:
- History of cigarette smoking within 3 months prior to the completion of screening or is unwilling to avoid tobacco products throughout program.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pirfenidone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2015.
- Derived from this study: PubMed 32026347Lancaster L, Morrison L, Auais A, Ding B, Iqbal A, Polman B, Flaherty KR. Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis: Experience from 92 Sites in an Open-Label US Expanded Access Program. Pulm Ther. 2017 Dec;3(2):317-325. doi: 10.1007/s41030-017-0049-z. Epub 2017 Sep 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pirfenidone in people with Idiopathic Pulmonary Fibrosis, run by Genentech, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02141087, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2015.