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

Liver Failure, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00225901
• Other study ID #: TRC02HG-I/II-1
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: September 21, 2005
• Last updated: September 22, 2005
• Start date: September 2005

Study information

• Verified date: September 2005
• Source: Kyoto University, Graduate School of Medicine
• Contact: Hirohito Tsubouchi, M.D.
• Phone: +81-75-751-4737
• Email: trchgf[@]kuhp.kyoto-u.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Failure
• Liver Failure, Acute

Intervention

Drug:
• Recombinant human hepatocyte growth factor

Locations

Country	Name	City	State
Japan	Kyoto University Hospital	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Kyoto University, Graduate School of Medicine

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All adverse effects throughout the protocol
Secondary	Survival time at 4 weeks
Secondary	Degree of hepatic encephalopathy at 3, 5, 8, 11, 15, 21, and 28 days
Secondary	Liver function test at at 3, 5, 8, 11, 15, 21, and 28 days

External Links

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