Actively Recruiting
Phase 2 Open-Label Study of Weekly Intravenous Foscenvivint for Men with Liver Cirrhosis from HIVHCV Co-infection and Hemophilia
Led by Kiminori Kimura, MD · Updated on 2026-08-05
4
Participants Needed
3
Research Sites
17 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of foscenvivint in men aged 18 to 79 who have liver cirrhosis caused by HIV and HCV co-infection along with hemophilia. This phase 2 study focuses on patients with Child-Pugh class A or B liver cirrhosis, aiming to understand how this treatment impacts their condition. Participants receive foscenvivint through an intravenous infusion once a week for 24 weeks. After completing the treatment period, there is a follow-up visit 4 weeks later to monitor any lasting effects or changes. The study is open-label and conducted at multiple centers. During the study, participants will undergo various assessments including measurement of liver function using the ALBI score from baseline through 24 weeks after treatment starts. Researchers will also monitor HIV viral load, CD4 cell counts, liver stiffness via FibroScan, imaging studies like abdominal CT scans, and overall health status. Safety and treatment adherence will be closely observed throughout the trial, which lasts approximately 28 weeks including follow-up.
CONDITIONS
Brief Title
A Phase 2 Study of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection With Hemophilia
Research Team
K
Kiminori Kimura, MD
A
Akemi Ikoma
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