Ignite Creation Date:
2024-05-06 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03536143
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2018-04-20
Brief Title:
A Phase III Study of KB103 a Topical HSV1-COL7 on DEB Patients
Sponsor:
Krystal Biotech Inc
Organization:
Krystal Biotech Inc
Study Overview
Official Title:
A Phase III Study of KB103 a Non-Integrating Replication-Incompetent HSV Vector Expressing the Human Collagen VII Protein for the Treatment of Dystrophic Epidermolysis Bullosa DEB
Status:
COMPLETED
Status Verified Date:
2022-11
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:
GEM-1
Brief Summary:
This study was conducted to assess the safety and efficacy of topical Beremagene Geperpavec KB103 HSV1-COL7 on DEB patients
Detailed Description:
The primary objectives were the evaluation of safety through incidence of adverse events associated with the administration of B-VEC as compared to placebo as well as the demonstration of molecular correction of the disease by establishing the presence of functional COL7 expression and anchoring fibrils AF formation post administration of B-VEC Additional primary objectives were to assess the proportion of wounds with complete wound closure 90 reduction from baseline wound surface area at Week 8 10 and 12 the duration of wound closure and the time to wound closure of B-VEC treated wounds as compared with placebo treated wounds
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None