NCT03358420

Brief Summary

The aim of this study is to examine the correlation between the severity of non-alcoholic steatohepatitis/non alcoholic fatty liver disease (NASH/NAFLD) in naïve and hepatitis C (HCV) positive patients and the amplitude of alpha-defensin immunohistochemical staining in liver biopsy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

November 27, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 30, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

7 months

First QC Date

November 27, 2017

Last Update Submit

November 27, 2017

Conditions

InflammationFatty Liver

Outcome Measures

Primary Outcomes (1)

  • Amplitude of immunohistochemical stain

    The amplitude of each slide will be graded from 1-4

    Six months

Interventions

Immunohistochemical stainingDIAGNOSTIC_TEST

Pathological liver slides to be immunohistochemically stained for alpha-defensin

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients attending our liver unit who underwent a liver biopsy with proven fatty liver disease

You may qualify if:

  • Fatty liver disease patients with liver biopsy

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hille Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

InflammationFatty Liver

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System Diseases

Study Officials

  • Rami Abu Fanne, MD

    Hillel Yaffe Medical Center

    STUDY DIRECTOR

Central Study Contacts

Rami Abu Fanne, MD

CONTACT

972-50-3573694ramia@hadassah.org.il

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2017

First Posted

November 30, 2017

Study Start

December 1, 2017

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

November 30, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)