NCT01679769

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
818

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 6, 2015

Status Verified

November 1, 2015

Enrollment Period

3.4 years

First QC Date

September 1, 2012

Last Update Submit

November 4, 2015

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • Evaluation of staging fibrosis with a combination of non-invasive parameters compared to liver biopsy

    within two weeks after liver biopsy

Secondary Outcomes (1)

  • Evaluation of staging inflammation with a combination of non-invasive parameters compared to liver biopsy

    within two weeks after liver biopsy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

liver biopsy samples and blood samples

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Guiqiang Wang, MD

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

  • Hong Zhao, MD

    Peking University First Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 1, 2012

First Posted

September 6, 2012

Study Start

May 1, 2012

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

November 6, 2015

Record last verified: 2015-11

Locations

CN(1)