Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080223
Status:
COMPLETED
Last Update Posted:
2017-04-17
First Post:
2004-03-24
Brief Title:
Safety Study of Oral Pirfenidone in Patients With Pulmonary FibrosisIdiopathic Pulmonary Fibrosis
Sponsor:
Genentech Inc
Organization:
Genentech Inc
Study Overview
Official Title:
An Open-Label Phase 2 Study of the Safety of Oral Pirfenidone in Patients With Pulmonary FibrosisIdiopathic Pulmonary Fibrosis
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the safety of treatment with pirfenidone up to 3600 mgd in patients with pulmonary fibrosisidiopathic pulmonary fibrosis PFIPF
Detailed Description:
This study has been designed as a rollover study to collectively include safety data from various previous studies
In addition InterMune has also initiated an Early Access Program to make pirfenidone available to a limited number of patients with idiopathic pulmonary fibrosis in the United States This program is also being conducted under this protocol Registration of patients with documented IPF has been closed as of October 2005
In addition InterMune has also initiated an Early Access Program to make pirfenidone available to a limited number of patients with idiopathic pulmonary fibrosis in the United States This program is also being conducted under this protocol Registration of patients with documented IPF has been closed as of October 2005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GA29989 | OTHER | Hoffmann-La Roche | None |