Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT04371627
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2021-05-28
First Post:
2020-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Viaskin® Peanut (DBV712) Expanded Access Protocol
Sponsor:
DBV Technologies
Organization:
Study Overview
Official Title:
Viaskin® Peanut (DBV712) Expanded Access Protocol in Peanut-Allergic Children
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2021-05
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:
This is an open label expanded access program for male and female patients ≥ 4 years old.
Detailed Description:
This study is an open-label Intermediate-size EAP designed to provide treatment access for eligible Peanut-Allergic Children. This EAP entails visits every three months to assess patient status, safety, and to provide drug supply. Viaskin® Peanut treatment will continue until, in the clinical judgment of the Investigator, the patient is no longer benefiting from continuation of the treatment, the drug becomes approved and available by prescription, or the study is terminated.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: