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Clinical Trials/NCT02167503
NCT02167503UnknownNot Applicable

A Retrospective-prospective Observational Study to Evaluate the Effect of Anti-viral Treatment on the Long-term Outcome in Patients With Chronic Hepatitis B (SEARCH-B Study)

Nanfang Hospital, Southern Medical University14 sites in 1 country10,000 target enrollmentStarted: May 2014Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
10,000
Locations
14
Primary Endpoint
Cumulative rates of hepatocellular carcinoma
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Observational
Observational Model
Cohort

Eligibility Criteria

Ages
30 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Cumulative rates of hepatocellular carcinoma

Time Frame: Year 5

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (14)

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