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.
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).
Liver stiffness measurement by FibroScan of ≥12.5 kPa, corresponding to fibrosis stage F4, at screening.
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.
Single group
Foscenvivint
DrugExperimental:Foscenvivint Administered by intravenous (IV) infusion over 3-4 hours Arm Description:Foscenvivint 280 mg/m2, once a week for 24 weeks
ALBI score
Change from baseline in ALBI score at 24 weeks after administration. ALBI score = (log10 bilirubin \[mg/dL\] x 17.1) x 0.66 + (albumin \[g/dL\] x 10 x -0.085)
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Kiminori Kimura, MD
Lead sponsor
Komagome Hospital
Sponsor institution
Japan Agency for Medical Research and Development
Collaborator
Ohara Pharmaceutical Co., Ltd.
Collaborator
