Viewing Study NCT00225901



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Last Modification Date: 2024-10-26 @ 9:19 AM
Study NCT ID: NCT00225901
Status: UNKNOWN
Last Update Posted: 2005-09-26
First Post: 2005-09-21

Brief Title: Phase III Study of Recombinant Human Hepatocyte Growth Factor in Fulminant Hepatic Failure
Sponsor: Kyoto University Graduate School of Medicine
Organization: Kyoto University Graduate School of Medicine

Study Overview

Official Title: Phase III Study of Recombinant Human Hepatocyte Growth Factor in Fulminant and Late-Onset Hepatic Failure
Status: UNKNOWN
Status Verified Date: 2005-09
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None