Liver Failure, Acute Clinical Trial
Official title:
Phase I/II Study of Recombinant Human Hepatocyte Growth Factor in Fulminant and Late-Onset Hepatic Failure
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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