NCT00225901

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2005

Completed
Last Updated

September 26, 2005

Status Verified

September 1, 2005

First QC Date

September 21, 2005

Last Update Submit

September 22, 2005

Conditions

Liver Failure, Acute

Outcome Measures

Primary Outcomes (1)

  • All adverse effects throughout the protocol

Secondary Outcomes (3)

  • 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

Interventions

Recombinant human hepatocyte growth factorDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of fulminant or late-onset hepatic failure
  • Must be unable to receive liver transplantation

You may not qualify if:

  • Under 16 years old
  • Cancer patients
  • Pregnancy-aged women
  • Impaired renal function
  • Impaired cardiac function
  • Severe complications including pneumonia, sepsis, DIC and so on

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

RECRUITING

Related Links

MeSH Terms

Conditions

Liver Failure, Acute

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Officials

  • Tsutomu Chiba, M.D.

    Kyoto University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hirohito Tsubouchi, M.D.

CONTACT

+81-75-751-4737trchgf@kuhp.kyoto-u.ac.jp

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 21, 2005

First Posted

September 26, 2005

Study Start

September 1, 2005

Last Updated

September 26, 2005

Record last verified: 2005-09

Locations

JP(1)