Observational Study on Patients With Chronic Hepatitis B | NCT02167503

Studies
Observational Study on Patients With Chronic Hepatitis B

NCT02167503

Sponsor

Nanfang Hospital, Southern Medical University

Status

Unknown status

Last Update Posted

Jun 19, 2014Estimated

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Chronic Hepatitis B

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

Jun 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

May 2020Estimated

Completion Date

Not provided

First Submitted Date

Jun 17, 2014

First Submission Date that Met QC Criteria

Jun 17, 2014

First Posted Date

Jun 19, 2014Estimated

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

Jun 17, 2014

Last Update Posted Date

Jun 19, 2014Estimated

Name	Class
National Health and Family Planning Commission, P.R.China	OTHER_GOV

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 study was conducted to evaluate the effect of anti-viral treatment on long-term outcome on patients with chronic hepatitis B.

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

10,000Estimated

Measure	Description	Time Frame
Cumulative rates of hepatocellular carcinoma		Year 5

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female, aged over 30 (inclusive) years of old
Patients has a history of diagnosis of chronic hepatitis B (ie. HBsAg positive for more than 6 months)
For patients with HBsAg positive, patients should be undergoing anti-viral treatment
For patients with HBsAg negative, a documented evidence of previous anti-viral treatment should be provided.
Life expectancy is more than 1 year
Good treatment compliance.

Exclusion Criteria:

Patients has a history of diagnosis of hepatocellular carcinoma
Patients with Child Pugh C
Coinfected with HCV, HDV and HIV
Suffering from other serious disease
Taking part in other clinical trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with chronic hepatitis B from hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jinlin Hou, MD	Contact	86-20-61641941		jlhousmu@163.com
Jian Sun, MD	Contact	86-20-62787432		doctorsunjian@163.com

Overall Officials

Name	Affiliation	Role
Jinlin Hou, MD	Nanfang Hospital, Southern Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Ditan Hospital	Recruiting	Beijing	Beijing Municipality		China

Condition Browse Module

MeSH Terms

ID	Term
D019694	Hepatitis B, Chronic

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided