Safety and pharmacokinetics of recombinant human hepatocyte growth factor (rh-HGF) in patients with fulminant hepatitis: a phase I/II clinical trial, following preclinical studies to ensure safety

Table 1 Patient characteristics

Patient No.	1	2	3	4
Age/Gender	67/M	71/F	64/F	40/M
Diagnosis/Etiology	FHSA/HEV	FHSA/unknown	LOHF/unknown	FHSA/drug
Reason for not receiving LT	donor¹	age²	donor¹	donor¹
Before rh-HGF administration
Grade of HE	II	II	V	0
Prothrombin time INR (%)	2.07 (33)	1.55 (49)	1.78 (37)	1.62 (43)
Albumin (g/dL)	2.9	3.2	2.9	2.9
T-Bil (mg/dL)	11.2	6.9	11.7	27.6
Direct/total bilirubin ratio	0.58	0.41	0.44	0.71
ALT (IU/L)	32	131	260	253
Serum HGF (ng/mL)	0.77	1.94	1.07	1.88
AFP (ng/ml)	7.0	22.9	3.9	39.7
Liver volume (mL)	1055	595	640	1110
Days between HE and rh-HGF administration (days)	7	5	5	5
Duration of rh-HGF dosing (days)	13	14	12	14
Outcome
during the study period	alive	alive	dead	alive
during the follow-up period	dead	alive	-	alive

FHSA, fulminant hepatitis subacute type; LOHF, late onset hepatc failure; HEV, hepatitis E virus; LT, liver transplantation; HE, hepatic encephalopathy. ¹lack of an appropriate donor; ²age 70 or over.

ISSN: 1479-5876