A Hepatitis B With Hepatic Steatosis Study | NCT02392598

Studies
A Hepatitis B With Hepatic Steatosis Study

NCT02392598

Sponsor

Fatty Liver and Alcoholic Liver Disease Study Group, China

Status

Unknown status

Last Update Posted

Aug 5, 2015Estimated

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Hepatitis B, Chronic
Hepatic Steatosis

Interventions

Not provided

Countries

China

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

Aug 2015

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

Aug 2015

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Mar 13, 2015

First Submission Date that Met QC Criteria

Mar 13, 2015

First Posted Date

Mar 19, 2015Estimated

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

Aug 3, 2015

Last Update Posted Date

Aug 5, 2015Estimated

Name	Class
Unimed Scientific Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This is an epidemiologic study on effect of hepatic steatosis on prognosis and outcomes of patients with chronic hepatitis B.

Detailed Description

This is a multicenter, prospective and open-enrollment epidemiologic study. All the patients with chronic hepatisis B will be enrolled in the study and followed up after 1 year, 3 years and 5 years with a visit window of +1 month.

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

Retention

Enrollment

3,000Estimated

Measure	Description	Time Frame
liver cirrhosis		5 years

Measure	Description	Time Frame
liver cancer		5 years
liver failure		5 years
type 2 diabetes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinically diagnosed chronic hepatitis B.
Specific biopsy requirements for hepatic steatosis: qualified biopsy specimen within 6 months, >5% hepatocytes show macrovesicular steatosis under HE staining and X10 microscope.
Willing to participate in the long-term follow-up and cooperative.
Able to provide informed consent file.

Exclusion Criteria:

Unable to provide informed consent.
Patients are eligible for baseline analysis but not eligible for follow-up, if having any of the following condition:
1. Any end-stage liver disease.
2. Any malignant tumor.
3. Any congenital liver disease such as Wilson disease.
4. Any other serious disease of projected survival < 5 years.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Any patients with chronic hepatisis B meeting eligibility criteria

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jiangao Fan, MD	Contact			fattyliver2004@126.com
Shiyan Yan, MD	Contact			shyyan2008phd@yahoo.com

Overall Officials

Name	Affiliation	Role
Jiangao Fan, MD	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhangzhou Zhengxing Hospital		Zhangzhou	Fujian		China

Condition Browse Module

MeSH Terms

ID	Term
D019694	Hepatitis B, Chronic
D005234	Fatty Liver

Ancestor Terms

ID	Term
D006509	Hepatitis B
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided