Liver Failure, Acute
Conditions
Brief summary
The purpose of this study is to determine whether recombinant human hepatocyte growth factor is safe and effective in the treatment of fulminant and late-onset hepatic failure.
Detailed description
Fulminant and late-onset hepatic failure (LOHF) is intractable disease with high degree of fatality (70-80%). Only liver transplantation is established as a therapeutic modality to rescue patients with fulminant hepatic failure or LOHF. However, approximately 75% of the patients are not able to receive liver transplantation in Japan, and effective non-surgical treatment has not been established yet. Hepatocyte growth factor (HGF) is one of major agents stimulating liver regeneration and ameliorating hepatic injury. In this study, recombinant human HGF is administered to patients with fulminant hepatic failure or LOHF, who can not receive liver transplantation.
Interventions
DRUGRecombinant human hepatocyte growth factor
Sponsors
Kyoto University, Graduate School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of fulminant or late-onset hepatic failure * Must be unable to receive liver transplantation
Exclusion criteria
* Under 16 years old * Cancer patients * Pregnancy-aged women * Impaired renal function * Impaired cardiac function * Severe complications including pneumonia, sepsis, DIC and so on
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All adverse effects throughout the protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival time at 4 weeks | — |
| Degree of hepatic encephalopathy at 3, 5, 8, 11, 15, 21, and 28 days | — |
| Liver function test at at 3, 5, 8, 11, 15, 21, and 28 days | — |
Countries
Japan
Contacts
Primary ContactHirohito Tsubouchi, M.D.
Outcome results
None listed