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Idiopathic Pulmonary FibrosisPhase 2NCT00080223

Safety Study of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis

A Phase 2 study testing Pirfenidone in people with Idiopathic Pulmonary Fibrosis and Pulmonary Fibrosis, run by Genentech, Inc. at 27 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess the safety of treatment with pirfenidone (up to 3600 mg/d) in patients with pulmonary fibrosis/idiopathic pulmonary fibrosis (PF/IPF). Read more about this study

Who is it for?
Ages 40 to 85 years
What is being tested?
Pirfenidone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
27 sitesUnited States
Study dates
31 Aug 2003to 30 Apr 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

General Inclusion Criteria:

  • Able to understand and sign an informed consent form
  • Understand the importance of adherence to study treatment and the study protocol, including concomitant medication restrictions, throughout the study period
  • Patients must be willing to travel to an approved regional center for all study-related visits

Roll-Over Criteria:

  • Entry into study through rollover has been completed

Criteria for Early Access Program patients:

  • Clinical symptoms consistent with IPF ≥3 months duration
  • Age 40 - 85, inclusive
  • At the time of registration with National Organization for Rare Disorders (NORD), patients with IPF must have a percent predicted forced vital capacity (FVC) of ≥50%, and percent predicted carbon monoxide diffusing capacity (DLCO) of ≥35%
  • At the time of enrollment in PIPF-002, (screening/baseline visit) percent predicted FVC must be ≥45%, and percent predicted DLCO must be ≥30%
  • High-resolution computed tomographic scan (HRCT) showing definite IPF. For patients with surgical lung biopsy showing definite or probable usual interstitial pneumonia (UIP), the HRCT criterion of probable IPF is sufficient
  • For patients aged <50 years: open or video-assisted thoracoscopic (VATS) lung biopsy showing definite or probable UIP. In addition, no features supporting an alternative diagnosis on transbronchial biopsy or bronchoalveolar lavage if performed
  • For patients aged ≥50 years: at least one of the following diagnostic findings as well as the absence of any features on specimens resulting from any of these procedures that support an alternative diagnosis: 1) Open or VATS lung biopsy showing definite or probable UIP; 2) Transbronchial biopsy showing no features to support an alternative diagnosis; 3) Bronchoalveolar lavage (BAL) showing no features to support an alternative diagnosis

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

United States27 sites

  • Study site

    Annandale, Virginia, 22003

  • Study site

    Atlanta, Georgia, 30322

  • Study site

    Boston, Massachusetts, 02118

  • Study site

    Bremerton, Washington, 98310 - 3349

  • Study site

    Dallas, Texas, 75390-8503

  • Study site

    Elk Grove Village, Illinois, 60007

  • Study site

    Houston, Texas, 77005

  • Study site

    Huntington Station, New York, 11746

  • Study site

    Kailua, Hawaii, 96734

  • Study site

    Lahaina, Hawaii, 96761

  • Study site

    Lancaster, Pennsylvania, 17601

  • Study site

    Nampa, Idaho, 83686

  • Study site

    New Haven, Connecticut, 06520

  • Study site

    New York, New York, 10016

  • Study site

    New York, New York, 10029-6574

  • Study site

    Phoenix, Arizona, 85006

  • Study site

    Pomona, California, 91767

  • Study site

    Portland, Oregon, 97220

  • Study site

    Portland, Oregon, 97227

  • Study site

    Provo, Utah, 84604

  • Study site

    Rochester, New York, 14620

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Jose, California, 95119

  • Study site

    Sarasota, Florida, 34239

  • Study site

    St Louis, Missouri, 63110

  • Study site

    West Roxbury, Massachusetts, 02132

  • Study site

    Worthington, Ohio, 43085

Other trials in United States

About this study

Official title: An Open-Label, Phase 2 Study of the Safety of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis

To assess the safety of treatment with pirfenidone (up to 3600 mg/d) in patients with pulmonary fibrosis/idiopathic pulmonary fibrosis (PF/IPF).

Read the detailed description

This study has been designed as a rollover study to collectively include safety data from various previous studies.

In addition, InterMune has also initiated an Early Access Program to make pirfenidone available to a limited number of patients with idiopathic pulmonary fibrosis in the United States. This program is also being conducted under this protocol. Registration of patients with documented IPF has been closed as of October 2005.

Being tested
Pirfenidone
Keywords
pulmonary fibrosis, respiratory diseases
Medical subject headings
Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Respiratory Tract Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PirfenidoneDrug

    up to 3600 mg/day of pirfenidone given orally administered in divided doses three times daily with food, for the duration of the study

Study groups in NCT00080223
Study groupRoleWhat they receive
PirfenidoneExperimentalup to 3600 mg/day of pirfenidone given orally administered in divided doses three times daily with food, for the duration of the study
Receives: Drug: Pirfenidone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With a Treatment-Emergent Adverse Event (AE), Serious AE (SAE), Severe AE, Life-threatening AE, Death or Discontinuation Because of an AE

    An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were classified as severe (Grade 3) in following cases: marked limitation in activity; some assistance usually required; medical intervention/ therapy required, hospitalization possible. Treatment-emergent AEs were those occurring on or after the first dosing day and up to 28 days after discontinuation of study treatment, and those occurring before treatment that worsened after the first study dose. AE included serious as well as non-serious AEs.

    Measured: Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)

Secondary outcomes (4)

  1. Percent Predicted Forced Vital Capacity (FVC)

    FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out from the lungs after full inspiration in the upright position, measured in liters. Predicted FVC is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (actual FVC value in liter)/(predicted FVC) * 100%

    Measured: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480

  2. Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)

    DLco is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. Predicted DLco is based on a formula using sex, age and height of a person. Predicted DLco = [Hbg-corrected DLco value (in milliliters per minute per millimeter mercury [mL/min/mmHg])/predicted DLco] * 100%

    Measured: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480

  3. Resting Oxygen Saturation by Pulse Oximetry (SpO2)

    SpO2 is the percentage of oxygen saturation in the blood. Oxygen level (oxygen saturation) of the blood was measured using pulse oximetry on room air.

    Measured: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480

  4. Overall Survival

    Survival was analyzed as time from first study dose to death (all-cause mortality) with surviving participants censored at their last available assessment.

    Measured: First dosing of study treatment until death (up to 604 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2004 (estimated)
  2. Study start31 Aug 2003
  3. Primary completion30 Apr 2015
  4. Study completion30 Apr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00080223
Sponsor's protocol ID
PIPF-002
Other IDs
GA29989
Status last verified
Mar 2017
First submitted
24 Mar 2004
Last updated
17 Apr 2017
Data monitoring committee
No

Publications

  • Gotfried MH, Girod CE, Antin-Ozerkis D, Burgess T, Strombom I, Stauffer JL, Kirchgaessler KU, Padilla ML. An Open-Label, Phase II Study of the Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (PIPF-002). Pulm Ther. 2018 Jun;4(1):59-71. doi: 10.1007/s41030-018-0053-y. Epub 2018 Apr 5.

    PubMed 32026243

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pirfenidone in people with Idiopathic Pulmonary Fibrosis and Pulmonary Fibrosis, run by Genentech, Inc. at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Percentage of Participants With a Treatment-Emergent Adverse Event (AE), Serious AE (SAE), Severe AE, Life-threatening AE, Death or Discontinuation Because of an AE (time frame: Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00080223, 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 17 Apr 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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