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NCT00662038 · ClinicalTrials.gov registry record · Phase 3
Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 3 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,058
- Enrollment target
NCT00662038: Completed Phase 3 study, sponsored by Genentech.
NCT00662038 is a Phase 3 study that has completed, run by Genentech. The registered enrollment target is 1,058 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00662038, a Phase 3 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,058 participants
- Enrollment target
Study Summary
This is an open-label, multi-center, extension study for patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone. The purpose of this study is to obtain additional safety data for pirfenidone 2403 mg/day in patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone.
Primary Outcome
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.
Interventions
- DRUG pirfenidone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,058 participants |
| Start Date | 2008-08 |
| Est. Completion | 2016-02 |
| Phase | Phase 3 |
What the finished NCT00662038 record still lists
NCT00662038 is an interventional study that assigns participants to a tested intervention. Its 1,058 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% higher).
The record links to 0 conditions, and to 1 intervention - of which pirfenidone is the first listed.
NCT00662038 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00662038 about?
NCT00662038 is a clinical study titled "Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)". This is an open-label, multi-center, extension study for patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone. The purpose of this study is to obtain additional safety data for pirfenidone 2403 mg/day in patients with IPF who complete a qualifying InterMune clinical tr...
What is the current status of trial NCT00662038?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,058 participants. The study started on 2008-08. Estimated completion is 2016-02.
What interventions are being tested in trial NCT00662038?
The interventions under investigation include: pirfenidone (DRUG).
Who is sponsoring clinical trial NCT00662038?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00662038's enrollment target sits among peer trials
1,058 276th of 2000 higher than 1,725 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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