Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-02-13 @ 2:35 PM
Study NCT ID:
NCT02074995
Status:
TERMINATED
Last Update Posted:
2016-03-07
First Post:
2014-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Tolerability and Efficacy of BVS857 in Severe Burn Subjects
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
Multiple Ascending, Sequential, Placebo-controlled, Double-blind Study to Assess Safety, Tolerability and Efficacy of BVS857 in Severe Burn Subjects
Status:
TERMINATED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was prematurely terminated due to recruitment issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study of tolerability and efficacy of BVS857 in severe burn subjects over 8 weeks and 15 weeks
Detailed Description:
No formal analysis was performed as study was terminated due to low enrollment issues. (n=1 patient was enrolled)
Study Oversight
Has Oversight DMC:
True
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?: