Trial · NCT00080223
Safety Study of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis
NCT00080223, Phase 2, Completed, Genentech, Inc.; results first posted 2016-03-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety Study of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis. Trials, record NCT00080223. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00080223
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis
- NCT number
- NCT00080223
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 83 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis
- Interventions
- Pirfenidone
- First posted
- 2004-03-26
- Last updated
- 2017-04-17
- Results first posted
- 2016-03-09
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks) | 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. |
| Secondary | Percent Predicted Forced Vital Capacity (FVC) | Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480 | 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% |
| Secondary | Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco) | Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480 | 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% |
| Secondary | Resting Oxygen Saturation by Pulse Oximetry (SpO2) | Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480 | 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. |
| Secondary | Overall Survival | First dosing of study treatment until death (up to 604 weeks) | Survival was analyzed as time from first study dose to death (all-cause mortality) with surviving participants censored at their last available assessment. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks) | All treated participants | percentage of participants | NUMBER |
| SECONDARY | Percent Predicted Forced Vital Capacity (FVC) | Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480 | All treated participants. n = participants who were evaluable for specified time point. | percent predicted FVC | MEAN |
| SECONDARY | Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco) | Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480 | All treated participants. n = participants who were evaluable for specified time point. | percent predicted DLco | MEAN |
| SECONDARY | Resting Oxygen Saturation by Pulse Oximetry (SpO2) | Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480 | All treated participants. n = participants who were evaluable for specified time point. | percentage of oxygen saturation | MEAN |
| SECONDARY | Overall Survival | First dosing of study treatment until death (up to 604 weeks) | All treated participants | weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Pirfenidone | Any AE | 98.8 | percentage of participants | |
| 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 | Pirfenidone | SAE | 59.0 | percentage of participants | |
| 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 | Pirfenidone | Severe AE | 36.1 | percentage of participants | |
| 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 | Pirfenidone | Life-threatening AE | 21.7 | percentage of participants | |
| 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 | Pirfenidone | AEs leading to death | 25.3 | percentage of participants | |
| 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 | Pirfenidone | AE leading to study treatment discontinuation | 43.4 | percentage of participants | |
| Percent Predicted Forced Vital Capacity (FVC) | Pirfenidone | Baseline (n=78) | 67.7 | Standard Deviation 18.70 | percent predicted FVC |
| Percent Predicted Forced Vital Capacity (FVC) | Pirfenidone | Week 24 (n=71) | 67.5 | Standard Deviation 17.11 | percent predicted FVC |
| Percent Predicted Forced Vital Capacity (FVC) | Pirfenidone | Week 48 (n=57) | 68.7 | Standard Deviation 17.36 | percent predicted FVC |
| Percent Predicted Forced Vital Capacity (FVC) | Pirfenidone | Week 72 (n=50) | 68.4 | Standard Deviation 16.20 | percent predicted FVC |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pirfenidone | 83 | |
| Overall Study | COMPLETED | Pirfenidone | 7 | |
| Overall Study | NOT COMPLETED | Pirfenidone | 76 |
Source ClinicalTrials.gov
Adverse events106
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Pirfenidone | 5 | 83 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Pirfenidone | 7 | 83 | |
| other | Constipation | Gastrointestinal disorders | Pirfenidone | 10 | 83 | |
| other | Diarrhoea | Gastrointestinal disorders | Pirfenidone | 10 | 83 | |
| other | Dyspepsia | Gastrointestinal disorders | Pirfenidone | 7 | 83 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Pirfenidone | 10 | 83 | |
| other | Nausea | Gastrointestinal disorders | Pirfenidone | 40 | 83 | |
| other | Stomach discomfort | Gastrointestinal disorders | Pirfenidone | 5 | 83 | |
| other | Vomiting | Gastrointestinal disorders | Pirfenidone | 13 | 83 | |
| other | Asthenia | General disorders | Pirfenidone | 8 | 83 |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pirfenidone | ||
| Total, other adverse events | Pirfenidone | 81 | 83 |
| Total, serious adverse events | Pirfenidone | 49 | 83 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32026243 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00080223
GET https://conductscience.org/api/trials/v1/NCT00080223/results?page=2