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

September 22, 2005 updated by: Kyoto University, Graduate School of Medicine

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

16

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kyoto, Japan, 606-8507
        • Recruiting
        • Kyoto University Hospital
        • Contact:
        • Principal Investigator:
          • Tsutomu Chiba, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
All adverse effects throughout the protocol

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyoto University, Graduate School of Medicine

Investigators

  • Principal Investigator: Tsutomu Chiba, M.D., Kyoto University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Registration Dates

First Submitted

September 21, 2005

First Submitted That Met QC Criteria

September 22, 2005

First Posted (Estimate)

September 26, 2005

Study Record Updates

Last Update Posted (Estimate)

September 26, 2005

Last Update Submitted That Met QC Criteria

September 22, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRC02HG-I/II-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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