Inflammation and Steatosis: the Role of Alpha-defensin | NCT03358420

Studies
Inflammation and Steatosis: the Role of Alpha-defensin

NCT03358420

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Nov 30, 2017Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Inflammation
Fatty Liver

Interventions

Immunohistochemical staining

Countries

Israel

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

Nov 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2017Estimated

Primary Completion Date

Jul 2018Estimated

Completion Date

Jul 2018Estimated

First Submitted Date

Nov 27, 2017

First Submission Date that Met QC Criteria

Nov 27, 2017

First Posted Date

Nov 30, 2017Actual

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

Nov 27, 2017

Last Update Posted Date

Nov 30, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Immunohistochemical staining	Diagnostic Test	Pathological liver slides to be immunohistochemically stained for alpha-defensin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amplitude of immunohistochemical stain	The amplitude of each slide will be graded from 1-4	Six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fatty liver disease patients with liver biopsy

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rami Abu Fanne, MD	Contact	972-50-3573694		ramia@hadassah.org.il

Overall Officials

Name	Affiliation	Role
Rami Abu Fanne, MD	Hillel Yaffe Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hille Yaffe Medical Center		Hadera		38100	Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007249	Inflammation
D005234	Fatty Liver

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided