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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Experimental:Foscenvivint Administered by intravenous (IV) infusion over 3-4 hours Arm Description:Foscenvivint 280 mg/m2, once a week for 24 weeks
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
RECRUITINGNational Hospital Organization Osaka National Hospital
Osaka, Osaka, Japan
RECRUITINGTokyo Metropolitan Komagome Hospital
Bunkyo-Ku, Tokyo, Japan
RECRUITINGALBI 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)
Time frame: Baseline to 24 weeks after administration
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