NCT06144086

A Phase 2 Trial of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection with Hemophilia (OP-724-H201)

A Multi-center, Single-arm, Open-label Phase 2 Trial of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection with Hemophilia

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Kiminori Kimura, MD · Academic / Other
• Sex: Male
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2 trial of foscenvivint in liver cirrhosis patients caused by HIV/HCV 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.

Conditions

• Liver Cirrhosis

Interventions

Type	Name	Description
DRUG	Foscenvivint	Administered by intravenous (IV) infusion over 3-4 hours

Timeline

• Start date: 2024-05-08
• Primary completion: 2025-12-31
• Completion: 2026-03-31
• First posted: 2023-11-22
• Last updated: 2025-03-17

Locations

3 sites across 1 country: Japan