Phase I/II Study of Recombinant Human Hepatocyte Growth Factor in Fulminant and Late-Onset Hepatic Failure
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- All adverse effects throughout the protocol
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
All adverse effects throughout the protocol
Secondary Outcomes
- 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