Trial · NCT00662038
Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
NCT00662038, Phase 3, Completed, Genentech, Inc.; results first posted 2017-03-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF). Trials, record NCT00662038. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00662038
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
- NCT number
- NCT00662038
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,058 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- pirfenidone
- First posted
- 2008-04-21
- Last updated
- 2017-03-29
- Results first posted
- 2017-03-29
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events | 7.5 years | An adverse event defined as any unfavorable, harmful, or pathologic change in a research participant administered a pharmaceutical study treatment as indicated by physical signs, symptoms, and/or clinically significant laboratory abnormalities that occurred during the treatment and the post-treatment period, regardless of suspected cause. |
Source ClinicalTrials.gov
Outcomes1
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 Adverse Events | 7.5 years | All participants who received any pirfenidone. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
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 Adverse Events | Pirfenidone | 98.0 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pirfenidone | 1,058 | |
| Overall Study | COMPLETED | Pirfenidone | 427 | |
| Overall Study | NOT COMPLETED | Pirfenidone | 631 |
Source ClinicalTrials.gov
Adverse events420
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 | Cataract | Eye disorders | Pirfenidone | 53 | 1,058 | |
| other | Abdominal pain | Gastrointestinal disorders | Pirfenidone | 60 | 1,058 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Pirfenidone | 66 | 1,058 | |
| other | Constipation | Gastrointestinal disorders | Pirfenidone | 118 | 1,058 | |
| other | Diarrhoea | Gastrointestinal disorders | Pirfenidone | 242 | 1,058 | |
| other | Dyspepsia | Gastrointestinal disorders | Pirfenidone | 126 | 1,058 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Pirfenidone | 102 | 1,058 | |
| other | Nausea | Gastrointestinal disorders | Pirfenidone | 305 | 1,058 | |
| other | Stomach discomfort | Gastrointestinal disorders | Pirfenidone | 53 | 1,058 | |
| other | Vomiting | Gastrointestinal disorders | Pirfenidone | 122 | 1,058 |
1 to 10 of 420Source ClinicalTrials.gov
See all 420 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 | 1,027 | 1,058 |
| Total, serious adverse events | Pirfenidone | 571 | 1,058 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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/NCT00662038
GET https://conductscience.org/api/trials/v1/NCT00662038/events?page=2