Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06144086
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-11-16
Brief Title:
A Phase 2 Trial of Foscenvivint in Liver Cirrhosis Patients Caused by HIVHCV Co-infection With Hemophilia OP-724-H201
Sponsor:
Kiminori Kimura MD
Organization:
Komagome Hospital
Study Overview
Official Title:
A Multi-center Single-arm Open-label Phase 2 Trial of Foscenvivint in Liver Cirrhosis Patients Caused by HIVHCV Co-infection With Hemophilia
Status:
RECRUITING
Status Verified Date:
2024-05
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 a phase 2 trial of foscenvivint in liver cirrhosis patients caused by HIVHCV co-infection with hemophilia to evaluate the efficacy safety and pharmacokinetics
Detailed Description:
This is designed a multi-center single-arm open-label trial of foscenvivint administered intravenously twice a week for 24 weeks A follow up visit will be conducted 4 weeks after the last administration
Liver cirrhosis patients due to co-infection of HIV and HCV with hemophilia who have a Child-Pugh classification of A or B are included
Liver cirrhosis patients due to co-infection of HIV and HCV with hemophilia who have a Child-Pugh classification of A or B are included
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| jRCT2031230461 | OTHER | Japan Registry of Clinical Trials jRCT | None |