Trial · NCT01366209

Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)

NCT01366209, Phase 3, Completed, Genentech, Inc.; results first posted 2015-03-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF). Trials, record NCT01366209. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01366209

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
NCT number: NCT01366209
Status: Completed
Phases: Phase 3
Enrollment: 555 participants, actual
Lead sponsor: Genentech, Inc.
Conditions: Idiopathic Pulmonary Fibrosis
Interventions: Pirfenidone, Placebo
First posted: 2011-06-03
Last updated: 2017-04-05
Results first posted: 2015-03-12

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52	52 weeks

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	Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52	52 weeks	Intent to Treat all randomized Patient	percentage of patients	NUMBER

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52	Active Arm	Decline or >=10% or Death	16.5	percentage of patients
Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52	Placebo Arm	Decline or >=10% or Death	31.8	percentage of patients
Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52	Active Arm	No Decline (Change >0%)	22.7	percentage of patients
Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52	Placebo Arm	No Decline (Change >0%)	9.7	percentage of patients

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Active Arm	278
Overall Study	STARTED	Placebo Arm	277
Overall Study	COMPLETED	Active Arm	243
Overall Study	COMPLETED	Placebo Arm	241
Overall Study	NOT COMPLETED	Active Arm	35
Overall Study	NOT COMPLETED	Placebo Arm	36

Source ClinicalTrials.gov

Adverse events288

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	Abdominal pain upper	Gastrointestinal disorders	Active Arm	20	278	33
other	Abdominal pain upper	Gastrointestinal disorders	Placebo Arm	12	277	14
other	Constipation	Gastrointestinal disorders	Active Arm	32	278	38
other	Constipation	Gastrointestinal disorders	Placebo Arm	38	277	39
other	Diarrhoea	Gastrointestinal disorders	Active Arm	62	278	112
other	Diarrhoea	Gastrointestinal disorders	Placebo Arm	60	277	101
other	Dyspepsia	Gastrointestinal disorders	Active Arm	49	278	61
other	Dyspepsia	Gastrointestinal disorders	Placebo Arm	17	277	22
other	Flatulence	Gastrointestinal disorders	Active Arm	12	278	13
other	Flatulence	Gastrointestinal disorders	Placebo Arm	17	277	18

1 to 10 of 288Source ClinicalTrials.gov

See all 288 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Active Arm
Total, all-cause mortality	Placebo Arm
Total, other adverse events	Active Arm	271	278
Total, other adverse events	Placebo Arm	253	277
Total, serious adverse events	Active Arm	55	278
Total, serious adverse events	Placebo Arm	69	277

Source ClinicalTrials.gov

Papers17

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24836312	DERIVED	PubMed
25856121	DERIVED	PubMed
26173796	DERIVED	PubMed
26835133	DERIVED	PubMed
26968970	DERIVED	PubMed
27708114	DERIVED	PubMed
28388260	DERIVED	PubMed
30072107	DERIVED	PubMed
30116539	DERIVED	PubMed
30472023	DERIVED	PubMed

1 to 10 of 17

See all 17 papers

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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Active Arm vs Placebo Arm: serious adverse events

Source Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01366209

GET https://conductscience.org/api/trials/v1/NCT01366209/events?page=2

API reference For AI assistants