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

Primary Purpose

Liver Failure, Acute

Status

Unknown status

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

Recombinant human hepatocyte growth factor

About this trial

This is an interventional treatment trial for Liver Failure, Acute

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Kyoto University HospitalRecruiting

Outcomes

Primary Outcome Measures

All adverse effects throughout the protocol

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00225901

First Posted

September 21, 2005

Last Updated

September 22, 2005

Sponsor

Kyoto University, Graduate School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00225901

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Unknown status

Study Start Date

September 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Kyoto University, Graduate School of Medicine

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Failure, Acute

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Recombinant human hepatocyte growth factor

Primary Outcome Measure Information:

Title

All adverse effects throughout the protocol

Secondary Outcome Measure Information:

Title

Survival time at 4 weeks

Title

Degree of hepatic encephalopathy at 3, 5, 8, 11, 15, 21, and 28 days

Title

Liver function test at at 3, 5, 8, 11, 15, 21, and 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hirohito Tsubouchi, M.D.

Phone

+81-75-751-4737

trchgf@kuhp.kyoto-u.ac.jp

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tsutomu Chiba, M.D.

Organizational Affiliation

Kyoto University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kyoto University Hospital

City

Kyoto

ZIP/Postal Code

606-8507

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hirohito Tsubouchi, M.D.

Phone

+81-75-751-4737

trchgf@kuhp.kyoto-u.ac.jp

First Name & Middle Initial & Last Name & Degree

Tsutomu Chiba, M.D.

12. IPD Sharing Statement

Links:

URL

http://www.kuhp.kyoto-u.ac.jp/~tr02hgf/index.html

Description

Related Info

Learn more about this trial

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

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