Phase I/II Study of Recombinant Human Hepatocyte Growth Factor in Fulminant Hepatic Failure
- Conditions
- Liver Failure, Acute
- Registration Number
- NCT00225901
- Lead Sponsor
- Kyoto University, Graduate School of Medicine
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 16
- Clinical diagnosis of fulminant or late-onset hepatic failure
- Must be unable to receive liver transplantation
- Under 16 years old
- Cancer patients
- Pregnancy-aged women
- Impaired renal function
- Impaired cardiac function
- Severe complications including pneumonia, sepsis, DIC and so on
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method All adverse effects throughout the protocol
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Kyoto University Hospital
🇯🇵Kyoto, Japan