Overview
This is a phase 2 study to evaluate the efficacy and safety of foscenvivint in patients with liver cirrhosis resulting from HIV/HCV co-infection in the setting of hemophilia.
Description
This is a multicenter, single-arm, open-label phase 2 study of foscenvivint administered intravenously once-weekly for 24 weeks. A follow-up visit will be conducted 4 weeks after the final administration.
Eligible patients are those with Child-Pugh class A or B liver cirrhosis resulting from HIV/HCV co-infection in the setting of hemophilia.
Eligibility
Inclusion Criteria:
- Patients with hemophilia and liver cirrhosis caused by HIV/HCV co-infection who meet both of the following criteria:
- Patients who are serum HIV-RNA positive or HIV antibody positive, with HIV-RNA maintained at \<200 copies/mL and a CD4-positive T lymphocyte count of ≥200 cells/µL at screening.
- Patients with HCV infection who have achieved sustained virologic response (SVR) at least 12 months before registration.
- Patients with Child-Pugh class A or B liver cirrhosis (Child-Pugh score 5-9).
- Patients who meet at least one of the following criteria for the diagnosis of liver cirrhosis:
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- Liver stiffness measurement by FibroScan of ≥12.5 kPa, corresponding to fibrosis stage F4, at screening.
- Abdominal CT showing changes in liver morphology and/or findings suggestive of portal hypertension.
- Patients with an Eastern Cooperative Oncology Group Performance Status of 0-2.
Exclusion Criteria:
- Patients with liver cirrhosis caused by etiologies other than HCV or of unknown etiology.
- Patients with esophageal or gastric varices judged by endoscopic examination at screening to require treatment.
- Patients with current malignancy or a history of malignancy within 3 years before registration.
- Patients who have undergone liver transplantation or other organ transplantation, including bone marrow transplantation.
- Patients with active AIDS-defining disease requiring treatment. -
