Ignite Creation Date:
2024-05-06 @ 7:04 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02460588
Status:
COMPLETED
Last Update Posted:
2022-06-30
First Post:
2015-03-16
Brief Title:
Cyclophosphamide for Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Cyclophosphamide Added to Corticosteroid in the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis a Placebo-controlled Randomized Trial
Status:
COMPLETED
Status Verified Date:
2022-06
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:
EXAFIP
Brief Summary:
Acute exacerbation of idiopathic pulmonary fibrosis AE-IPF is a major event of IPF with an annual incidence between 5 and 10 and is responsible for the death of one third of IPF patients When AE-IPF occurs it is associated with poor survival with an overall mortality at 3 months upper of 50 To date no treatment has been proved to be effective in AE-IPF but the efficacy of cyclophosphamide CYC on survival has been suggested mainly by retrospective series and needs to be confirmed This confirmation is mandatory to improve prognosis of AE-IPF but also to avoid unsuspected deleterious effect as it as been shown with immunosuppressor in stable IPF
Detailed Description:
Acute exacerbation of idiopathic pulmonary fibrosis AE-IPF is a major event of IPF with an annual incidence between 5 and 10 and is responsible for the death of one third of IPF patients When AE-IPF occurs it is associated with poor survival with an overall mortality at 3 months upper of 50 To date no treatment has been proved to be effective in AE-IPF but the efficacy of CYC on survival has been suggested mainly by retrospective series and needs to be confirmed This confirmation is mandatory to improve prognosis of AE-IPF but also to avoid unsuspected deleterious effect as it as been shown with immunosuppressor in stable IPF
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 |
|---|---|---|---|
| 2015-000492-27 | EUDRACT_NUMBER | None | None |