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Phase I/II Study of Recombinant Human Hepatocyte Growth Factor in Fulminant Hepatic Failure

Liver Failure, Acute Clinical Trial

Official title:
Phase I/II Study of Recombinant Human Hepatocyte Growth Factor in Fulminant and Late-Onset Hepatic Failure

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00225901
Study type Interventional
Source Kyoto University, Graduate School of Medicine
Contact Hirohito Tsubouchi, M.D.
Phone +81-75-751-4737
Email trchgf@kuhp.kyoto-u.ac.jp
Status Recruiting
Phase Phase 1/Phase 2
Start date September 2005
View Details
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