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

Kyoto University, Graduate School of Medicine

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Liver Failure, Acute

Treatments: Drug: Recombinant human hepatocyte growth factor

Study type: Interventional

Funder types: Other

Identifiers

NCT00225901

TRC02HG-I/II-1

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)