Phase I/II Study of Recombinant Human Hepatocyte Growth Factor in Fulminant Hepatic Failure
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|ClinicalTrials.gov Identifier: NCT00225901|
Recruitment Status : Unknown
Verified September 2005 by Kyoto University, Graduate School of Medicine.
Recruitment status was: Recruiting
First Posted : September 26, 2005
Last Update Posted : September 26, 2005
|Condition or disease||Intervention/treatment||Phase|
|Liver Failure, Acute||Drug: Recombinant human hepatocyte growth factor||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Recombinant Human Hepatocyte Growth Factor in Fulminant and Late-Onset Hepatic Failure|
|Study Start Date :||September 2005|
- All adverse effects throughout the protocol
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00225901
|Contact: Hirohito Tsubouchi, M.D.||+firstname.lastname@example.org|
|Kyoto University Hospital||Recruiting|
|Kyoto, Japan, 606-8507|
|Contact: Hirohito Tsubouchi, M.D. +81-75-751-4737 email@example.com|
|Principal Investigator: Tsutomu Chiba, M.D.|
|Principal Investigator:||Tsutomu Chiba, M.D.||Kyoto University|