Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00287716 · ClinicalTrials.gov registry record · Phase 3
Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
A Phase 3 study of Idiopathic Pulmonary Fibrosis, sponsored by Genentech.
- Completed
- Registry status
- Phase 3
- Development phase
- 435
- Enrollment target
- 1
- Study location
NCT00287716: Completed Phase 3 study of Idiopathic Pulmonary Fibrosis, sponsored by Genentech.
NCT00287716 is a Phase 3 study of Idiopathic Pulmonary Fibrosis that has completed, run by Genentech. The registered enrollment target is 435 participants, below the 743-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (41% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00287716, a Phase 3 study of Idiopathic Pulmonary Fibrosis, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 435 participants
- Enrollment target
- 1
- Study location
Study Summary
The objectives of this study are to assess the safety and efficacy of treatment with pirfenidone 2403 milligrams per day (mg/d) compared with placebo in patients with idiopathic pulmonary fibrosis (IPF), to assess the safety and efficacy of treatment with pirfenidone 1197 mg/d in patients with idiopathic pulmonary fibrosis and to characterize the pharmacokinetic disposition of pirfenidone in patients with idiopathic pulmonary fibrosis.
Primary Outcome
Mean Change in Percent Predicted Forced Vital Capacity (FVC) as measured from baseline to week 72.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pirfenidone
Study Locations (1)
California
- InterMune, Inc. - Brisbane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 435 participants |
| Start Date | 2006-07-14 |
| Est. Completion | 2008-11-10 |
| Phase | Phase 3 |
What the finished NCT00287716 record still lists
NCT00287716 is an interventional study that assigns participants to a tested intervention. The registered 435 participants enrollment target is mid-sized for trials with a published cap, below the 743-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (41% lower).
The record links to 1 condition, with Idiopathic Pulmonary Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00287716 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00287716 about?
NCT00287716 is a clinical study titled "Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis". The objectives of this study are to assess the safety and efficacy of treatment with pirfenidone 2403 milligrams per day (mg/d) compared with placebo in patients with idiopathic pulmonary fibrosis (IPF), to assess the safety and efficacy of treatment with pirfenidone 1197 mg/d in patients with idiop...
What is the current status of trial NCT00287716?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 435 participants. The study started on 2006-07-14. Estimated completion is 2008-11-10.
What conditions does trial NCT00287716 study?
This clinical trial studies the following conditions: Idiopathic Pulmonary Fibrosis.
What interventions are being tested in trial NCT00287716?
The interventions under investigation include: Placebo (DRUG), Pirfenidone (DRUG).
Who is sponsoring clinical trial NCT00287716?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00287716 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Idiopathic Pulmonary Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00287716's enrollment target sits among peer trials
435 12th of 51 higher than 40 of 51 other Idiopathic Pulmonary Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Idiopathic Pulmonary Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast
RECRUITING · Phase 3
-
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
COMPLETED · Phase 3
-
A Phase 2 Study of CAL101 in Patients With Idiopathic Pulmonary Fibrosis
RECRUITING · Phase 2
-
Zinc and Nicotinamide Riboside for Idiopathic Pulmonary Fibrosis
RECRUITING · Phase 2
-
Hyperpolarized Xenon-129 MRI in Idiopathic Pulmonary Fibrosis
RECRUITING · Early Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05563220 · 435 participants · Phase 1
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
- NCT07088926 · 435 participants · Phase 2
A Study to Evaluate the Efficacy, Safety, and PK of AZD0292 Administered IV in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization
- NCT02622542 · 436 participants · NA
ACute Uncomplicated Type b Aortic Dissection: Endovascular Repair vs. Best Medical Therapy
- NCT05918211 · 436 participants · Phase 3
Fontan Udenafil Exercise Longitudinal Assessment Trial - 2
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI