Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287729
Status:
COMPLETED
Last Update Posted:
2017-04-17
First Post:
2006-02-06
Brief Title:
Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Sponsor:
Genentech Inc
Organization:
Genentech Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo Controlled Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic 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:
The purposes of this study are to assess the efficacy of treatment with pirfenidone 2403 milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis IPFand to assess the safety of treatment with pirfenidone 2403 milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis
Detailed Description:
This is a Phase 3 randomized double-blind placebo-controlled safety and efficacy study of pirfenidone in patients with idiopathic pulmonary fibrosis IPF Approximately 320 patients at approximately 50 centers will be randomly assigned 11 to receive pirfenidone 2403 milligrams or placebo equivalent administered in divided doses three times per day TID with food The primary outcome variable will be the absolute change in percent predicted Forced Vital Capacity from Baseline to Week 72 Patients will be randomized by geographic region
Patients will receive blinded study treatment from the time of randomization until the last patient randomized has been treated for 72 weeks A Data Monitoring Committee DMC will periodically review safety and efficacy data to ensure patient safety
After week 72 patients who meet the Progression of Disease POD definition which is a 10 absolute decrease in percent predicted Forced Vital Capacity or a 15 absolute decrease in percent predicted carbon monoxide diffusing capacity DLco will be eligible to receive permitted idiopathic pulmonary fibrosis therapies in addition to their blinded study drug Permitted idiopathic pulmonary therapies include corticosteroids azathioprine cyclophosphamide and N-acetyl-cysteine with restrictions
Patients will receive blinded study treatment from the time of randomization until the last patient randomized has been treated for 72 weeks A Data Monitoring Committee DMC will periodically review safety and efficacy data to ensure patient safety
After week 72 patients who meet the Progression of Disease POD definition which is a 10 absolute decrease in percent predicted Forced Vital Capacity or a 15 absolute decrease in percent predicted carbon monoxide diffusing capacity DLco will be eligible to receive permitted idiopathic pulmonary fibrosis therapies in addition to their blinded study drug Permitted idiopathic pulmonary therapies include corticosteroids azathioprine cyclophosphamide and N-acetyl-cysteine with restrictions
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 |
|---|---|---|---|
| Capacity 1 | None | None | None |