Brief Summary

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

Trial Health

Monitor

Trial Health Score

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

Enrollment

10,000

participants targeted

Target at P75+ for all trials

Geographic Reach

1 country

14 active sites

Status

unknown

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, 2014

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2014

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2014

Completed

5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed

Last Updated

June 19, 2014

Status Verified

June 1, 2014

Enrollment Period

6 years

First QC Date

June 17, 2014

Last Update Submit

June 17, 2014

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

Cumulative rates of hepatocellular carcinoma
Year 5

Eligibility Criteria

Age30 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients with chronic hepatitis B from hospital

You may qualify if:

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.