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

• Status: Recruiting
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kiminori Kimura, MD
• Collaborator: Japan Agency for Medical Research and Development

Criteria

Key Inclusion Criteria

• Hemophilia patients with liver cirrhosis caused by HIV/HCV co-infection that fall under the following 1) and 2):

1. Serum HIV-RNA positive or HIV antibody positive patients (maintaining HIV-RNA < 200 copies/mL and CD4 positive T lymphocyte count >= 200 cells/µL at screening).

2. Regarding HCV, patients who had passed >= 12 months after achieving SVR at registration.

• Patients with Child-Pugh classification A or B (Child-Pugh score 5-9).

• Patients who meet at least one of 1) to 2) for diagnosis of liver cirrhosis:

1. Liver stiffness measurement by FibroScan is >= 12.5 kPa (Fibrosis stage F4) at screening.

2. Abdominal CT scan shows changes in liver shape and/or portal hypertension.

• Patients with Performance Status 0-2.

Key Exclusion Criteria

• Patients with liver cirrhosis of which cause is not HCV or unknown.

• Patients with esophageal gastric varices judged to require treatment by endoscopic examinations at screening.

• Patients with complication or history of malignant tumor (within 3 years before registration).

• Patients who have undergone liver transplantation or other organ transplantation (including bone marrow transplantation).

• Patients with active AIDS-indicator disease that require treatment.