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

Korábbi kezelés

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

Más betegség

• Patients with liver cirrhosis of which cause is not HCV or unknown.
• Patients with complication or history of malignant tumor (within 3 years before registration).
• Patients with active AIDS-indicator disease that require treatment.

Egyéb

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

• Hemophilia patients with liver cirrhosis caused by HIV/HCV co-infection that fall under the following 1) and 2):
  • 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).
  • 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:
  • Liver stiffness measurement by FibroScan is >= 12.5 kPa (Fibrosis stage F4) at screening.
  • Abdominal CT scan shows changes in liver shape and/or portal hypertension.
• Patients with Performance Status 0-2.