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

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.

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.

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.