Follow-up of Chronic Hepatitis B Patients With Comorbid N... | NCT02863757

Studies
Follow-up of Chronic Hepatitis B Patients With Comorbid Nonalcoholic Fatty Liver Disease

NCT02863757

Sponsor

Humanity and Health Research Centre

Status

Recruiting

Last Update Posted

Mar 24, 2025Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Chronic Hepatitis B
Nonalcoholic Fatty Liver Disease

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

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2016Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Aug 4, 2016

First Submission Date that Met QC Criteria

Aug 8, 2016

First Posted Date

Aug 11, 2016Estimated

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

Mar 20, 2025

Last Update Posted Date

Mar 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to determine the disease progression in CHB/NAFLD compared with CHB and NAFLD including liver cirrhosis, cirrhotic complications and hepatocellular carcinoma (HCC).

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

1,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CHB Group		Patients with chronic hepatitis B
CHB/NAFLD Group		Patients with chronic hepatitis B and comorbid nonalcoholic fatty liver disease
NAFLD Group		Patients with nonalcoholic fatty liver disease

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with liver cirrhosis, hepatic encephalopathy, esophageal varices, ascites and hepatocellular carcinoma		Up to 20 years

Secondary Outcomes

Measure	Description	Time Frame
Number of patients with hypertension, obesity, diabetes mellitus, hyperlipidaemia		Up to 20 years
Number of patients with liver transplantation and liver-related death		Up to 20 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Liver biopsy proved CHB and/or NAFLD at baseline;
Chinese
Follow-up duration>12 months

Exclusion Criteria:

Other liver diseases;
Secondary causes of hepatic steatosis;
Alcohol abuse;
Liver cirrhosis, cirrhosis related complications or HCC at baseline;
Malignancy;
History of liver transplantation

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

Hosptials and primary care clinics

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
George Lau, MD	Contact	+852 2861 3777		gkklau@netvigator.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Humanity and Health GI and Liver Centre	Recruiting	Hong Kong	Hong Kong	00852	China

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
D019694	Hepatitis B, Chronic
D065626	Non-alcoholic Fatty Liver Disease

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided