Phase I/II Study of Recombinant Human Hepatocyte Growth F... | NCT00225901

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

NCT00225901

Sponsor

Kyoto University, Graduate School of Medicine

Status

Unknown status

Last Update Posted

Sep 26, 2005Estimated

Enrollment

Phase

Phase 1Phase 2

Conditions

Liver Failure, Acute

Interventions

Recombinant human hepatocyte growth factor

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 21, 2005

First Submission Date that Met QC Criteria

Sep 22, 2005

First Posted Date

Sep 26, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2005

Last Update Posted Date

Sep 26, 2005Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Recombinant human hepatocyte growth factor	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All adverse effects throughout the protocol

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hirohito Tsubouchi, M.D.	Contact	+81-75-751-4737		trchgf@kuhp.kyoto-u.ac.jp

Overall Officials

Name	Affiliation	Role
Tsutomu Chiba, M.D.	Kyoto University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyoto University Hospital	Recruiting	Kyoto	Kyoto	606-8507	Japan

Condition Browse Module

MeSH Terms

ID	Term
D017114	Liver Failure, Acute

Ancestor Terms

ID	Term
D017093	Liver Failure
D048550	Hepatic Insufficiency
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided