To investigate the safety and efficacy of PRI-724 against HCV or HBV liver cirrhosis.
【Phase I Phase】 To evaluate safety and pharmacokinetics when PRI-724 is administered to patients with HCV or HBV liver cirrhosis , and determine the recommended dose of PRI-724. 【Phase IIa phase】 To evaluate the efficacy and safety of the recommended dose of PRI-724 administered to patients with HCV or HBV liver cirrhosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
twice a week for 4 hours continuous intravenous administration of PRI-724
Kohnodai Hospital, National Center for Global Health and Medicine
Ichikawa, Chiba, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyō-Ku, Tokyo, Japan
Kyushu University Hospital
Fukuoka, Japan
Serious side effect expression rate
(Phase I)Serious side effect expression rate
Time frame: 12 weeks after administration
liver tissue fibrosis area ratio by liver biopsy
(Phase II) Amount of change from the baseline in liver tissue fibrosis area ratio by liver biopsy at 12 weeks after administration
Time frame: 12 weeks after administration
Adverse Event Expression Ratio
Adverse Event Expression Ratio after PRI-724 treatment
Time frame: 12 weeks after administration
Percentage of occurrence of side effects
Percentage of occurrence of side effects after PRI-724 treatment
Time frame: 12 weeks after administration
Pharmacokinetic parameter
Maximum Plasma Concentration (Cmax)
Time frame: 12 weeks after administration
liver stiffness from Fibro Scan
Amount of change from measurement of liver stiffness by baseline from Fibro Scan at 12 weeks after administration
Time frame: 12 weeks after administration
Child Pugh score
Amount of change from baseline of Child-Pugh Score at 12 weeks after administration Child Pugh score (scale range 5-15) is obtained by adding the score for each parameter (encephalopathy, ascites, bilirubin, albumin, PT or INR).
Time frame: 12 weeks after administration
MELD score
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Amount of change from baseline for MELD score at 12 weeks after administration The Model for End-Stage Liver Disease (MELD) is a scoring system for assessing the severity of chronic liver disease and uses the subject's values for total bilirubin, serum creatinine, and the international normalized ratio (INR) for prothrombin time to predict survival. MELD is calculated according to the following formula: MELD = 3.78×ln\[serum bilirubin (mg/dL)\] + 11.2×ln\[INR\] + 9.57×ln\[serum creatinine (mg/dL)\] + 6.43
Time frame: 12 weeks after administration
modified Histological Activity Index (HAI) by liver biopsy
Change amount from baseline of modified Histological Activity Index (HAI) by liver biopsy at 12 weeks after administration
Time frame: 12 weeks after administration