Prospective Study In Noninvasive Evaluation of Hepatic Fi... | NCT01679769

Studies
Prospective Study In Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis B

NCT01679769

Sponsor

Peking University First Hospital

Status

Completed

Last Update Posted

Nov 6, 2015Estimated

Enrollment

818Actual

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

ID	Type	Description	Link
81170386	Other Grant/Funding Number	from The National Natural Science Foundation of China

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Oct 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Sep 1, 2012

First Submission Date that Met QC Criteria

Sep 1, 2012

First Posted Date

Sep 6, 2012Estimated

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 4, 2015

Last Update Posted Date

Nov 6, 2015Estimated

Name	Class
Beijing Municipal Science & Technology Commission	OTHER

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 aim of our study is to evaluate liver fibrosis using biochemical markers, FibroScan, and radiology methods in patients with chronic hepatitis B in mainland China.

Detailed Description

Up to Nov, 2015, total of 818 patients with chronic HBV infection had been enrolled in the study. Paired blood and liver biopsy specimen had been collected. The serum samples stored at -80 degree Celsius. All the liver biopsy samples were judged by three pathology experts, according to Ishak standard.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

818Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of staging fibrosis with a combination of non-invasive parameters compared to liver biopsy		within two weeks after liver biopsy

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of staging inflammation with a combination of non-invasive parameters compared to liver biopsy		within two weeks after liver biopsy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinical diagnosis of chronic hepatitis B or compensated cirrhosis due to chronic hepatitis B virus infection
agree to have liver biopsy

Exclusion Criteria:

clinical diagnosis of decompensated cirrhosis due to hepatitis B virus or inactive carrier
liver diseases due to other origin

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

patients with chronic hepatitis B or compensated cirrhosis due to chronic hepatits B virus (HBV) infection

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guiqiang Wang, MD	Peking University First Hospital	Principal Investigator
Hong Zhao, MD	Peking University First Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University First Hospital		Beijing	Beijing Municipality	100034	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