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

NCT ID: NCT00225901

Last Updated: 2005-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Brief Summary

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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

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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.

Conditions

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Liver Failure, Acute

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Recombinant human hepatocyte growth factor

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyoto University, Graduate School of Medicine

OTHER

Sponsor Role lead

Principal Investigators

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Tsutomu Chiba, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kyoto University Hospital

Locations

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Kyoto University Hospital

Kyoto, Kyoto, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Hirohito Tsubouchi, M.D.

Role: CONTACT

Phone: +81-75-751-4737

Email: [email protected]

Facility Contacts

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Hirohito Tsubouchi, M.D.

Role: primary

Related Links

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

Related Info

Other Identifiers

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TRC02HG-I/II-1

Identifier Type: -

Identifier Source: org_study_id