NCT00225901

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (planned)
• Sponsor: Kyoto University, Graduate School of Medicine · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Failure, Acute

Interventions

Type	Name	Description
DRUG	Recombinant human hepatocyte growth factor

Timeline

• Start date: 2005-09-01
• First posted: 2005-09-26
• Last updated: 2005-09-26

Locations

1 site across 1 country: Japan