Ignite Creation Date:
2024-07-17 @ 11:18 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474442
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-13
Brief Title:
A Phase Ⅱa Study of the Safety Tolerability and Efficacy of BD111 in Herpes Simplex Virus Type I Stromal Keratitis
Sponsor:
Shanghai BDgene Co Ltd
Organization:
Shanghai BDgene Co Ltd
Study Overview
Official Title:
A Multicenter Single-blind Single-dose Randomized Phase Ⅱa Trial to Evaluate the Safety Tolerability and Efficacy of Intrastromal BD111 Gene Editing Therapy in Adults With HSV-1 Stromal Keratitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
This study aims to compare the clinical efficacy and safety of BD111 injection in combination with standard therapy vs standard therapy in herpes simplex virus type I stromal keratitis HSK providing preliminary confirmation of the clinical effectiveness of BD111 in combination with standard therapy
Detailed Description:
This is a phase Ⅱa single-blind single-dose randomized positively controlled clinical trial of BD111 in patients with herpes simplex virus type I stromal keratitis HSK aged 18 to 70 years Forty eligible participants will be recruited in the trial BD111 is investigational new biologics Injection--a type of lentiviral-like particle that can simultaneously deliver SpCas9 and gRNA targeting the HSV-1 virus gene also known as HSV-1-erasing lentiviral particles HELP The total follow-up duration was 12 months the safe endpoints and efficacy endpoints will be used to assess the efficacy safety and tolerability profiles in patients with HSK
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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