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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by:
Kyoto University, Graduate School of Medicine

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.

Condition or disease Intervention/treatment Phase
Liver Failure, Acute Drug: Recombinant human hepatocyte growth factor Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Recombinant Human Hepatocyte Growth Factor in Fulminant and Late-Onset Hepatic Failure
Study Start Date : September 2005



Primary Outcome Measures :
  1. All adverse effects throughout the protocol

Secondary Outcome Measures :
  1. Survival time at 4 weeks
  2. Degree of hepatic encephalopathy at 3, 5, 8, 11, 15, 21, and 28 days
  3. Liver function test at at 3, 5, 8, 11, 15, 21, and 28 days


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of fulminant or late-onset hepatic failure
  • Must be unable to receive liver transplantation

Exclusion Criteria:

  • Under 16 years old
  • Cancer patients
  • Pregnancy-aged women
  • Impaired renal function
  • Impaired cardiac function
  • Severe complications including pneumonia, sepsis, DIC and so on

Information from the National Library of Medicine

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


Contacts
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Contact: Hirohito Tsubouchi, M.D. +81-75-751-4737 trchgf@kuhp.kyoto-u.ac.jp

Locations
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Japan
Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
Contact: Hirohito Tsubouchi, M.D.    +81-75-751-4737    trchgf@kuhp.kyoto-u.ac.jp   
Principal Investigator: Tsutomu Chiba, M.D.         
Sponsors and Collaborators
Kyoto University, Graduate School of Medicine
Investigators
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Principal Investigator: Tsutomu Chiba, M.D. Kyoto University

Additional Information:
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ClinicalTrials.gov Identifier: NCT00225901    
Other Study ID Numbers: TRC02HG-I/II-1
First Posted: September 26, 2005    Key Record Dates
Last Update Posted: September 26, 2005
Last Verified: September 2005
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
Liver Failure, Acute
Liver Diseases
Digestive System Diseases
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action