Phase 2 Interstitial Lung Disease Trial, Completed NCT00080223 Sponsor: Genentech, Inc. Condition: Interstitial Lung Disease
Back to Interstitial Lung Disease

Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 83 participants, all of whom received the study drug pirfenidone. Only 7 participants completed the study, while 76 did not complete it. The trial was primarily measuring how often participants experienced unwanted medical events (called adverse events) while taking the study drug. It also tracked several measures of lung function and breathing over time, as well as how long participants survived. The reported data shows that the vast majority of participants — 98.8% — experienced at least one adverse event (an unwanted medical occurrence linked to the study drug) during the trial. Of those, 59.0% experienced a serious adverse event (one serious enough to require hospitalisation or posing an immediate risk of dying, among other criteria), 36.1% had a severe adverse event (meaning it markedly limited their activity or required medical treatment), 21.7% experienced a life-threatening adverse event, 25.3% died, and 43.4% stopped taking the study drug because of an adverse event. For the lung function measures, the reported data shows that participants' lung capacity (measured as a percentage of what would be expected for a healthy person of the same age, sex and height) hovered around 65–70% across the various measurement points throughout the study. A separate measure of how well the lungs transfer oxygen into the blood sat at roughly 35–40% of the predicted healthy level across measurement points. Resting blood oxygen levels remained relatively stable across measurements, generally around 94–96%. The reported data also shows that the median survival time from the first dose was approximately 508.7 weeks (roughly 9–10 years), though the way this figure was calculated means it may reflect varying lengths of follow-up among participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Interstitial Lung Disease Trial, Completed

NCT00080223
Completed Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You must be able to understand and sign a consent form agreeing to take part in the study
  • You must understand how important it is to follow the study rules, including restrictions on other medications, throughout the entire study
  • You must be willing to travel to an approved regional center for all study-related appointments
  • Some participants may be able to join through a special "roll-over" process if they were already enrolled through a previous related program (confirm with trial site)
  • You must have symptoms consistent with a lung disease called IPF (idiopathic pulmonary fibrosis) that have lasted at least 3 months
  • You must be between 40 and 85 years old
  • At the time of first registering with a specific patient organization (NORD), your lung function tests must show your lungs are working at least 50% as well as expected for your age, and your ability to transfer oxygen into the blood must be at least 35% of what is expected
  • At the time of joining the study itself, your lung function must be at least 45% of what is expected, and your oxygen transfer ability must be at least 30% of expected
  • A special type of chest scan (a high-resolution CT scan) must clearly show signs of IPF
  • If you are under 50 years old, you must have had a surgical lung biopsy confirming the specific pattern of lung scarring associated with IPF, with no signs pointing to a different diagnosis
  • If you are 50 years old or older, at least one of several diagnostic tests (surgical lung biopsy, a small tissue sample taken through a breathing tube, or a fluid sample from the lungs) must support the IPF diagnosis, with no results suggesting a different condition

Who may not be able to join:

  • There are no specific exclusion criteria listed in the provided information (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
31 August 2003
Est. completion
30 April 2015

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

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

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov