Clinical Trial: Phase I/II Study of Recombinant Human Hepatocyte Growth Factor in Fulminant Hepatic Failure
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Phase I/II Study of Recombinant Human Hepatocyte Growth Factor in Fulminant and Late-Onset Hepatic Failure
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 Summary:
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.
Sponsor: Kyoto University, Graduate School of Medicine
Current Primary Outcome: All adverse effects throughout the protocol
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
Original Secondary Outcome: Same as current
Information By: Kyoto University, Graduate School of Medicine
Dates:
Date Received: September 21, 2005
Date Started: September 2005
Date Completion:
Last Updated: September 22, 2005
Last Verified: September 2005
