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Management of patients with chronic hepatitis B and low-level viremia treated by entecavir

Management of patients with chronic hepatitis B and low-level viremia treated by entecavir

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043266
Enrollment
Unknown
Registered
2021-02-09
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B virus

Interventions

TDF group :Daily oral tenofovir disoproxil fumarate tablets 300mg
TDF+ETV group:Daily oral tenofovir disoproxil fumarate tablets 300mg combined with entecavir dispersible tablets 0.5mg
ETV group:Daily oral entecavir dispersible tablets 0.5mg
TAF group:Tenofovir alafenamide fumarate tablets 25mg orally daily

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The subjects of this study were patients with chronic hepatitis B and LLV who had at least one year of initial treatment for ETV in the outpatient clinic of Xuzhou Medical University Affiliated Hospital from November 2018 to March 2021. (1) Chronic HBV infection (hepatitis B surface antigen or clinical history of 6 months or more); (2) Adults 18 years or older; (3) Entecavir daily for newly-treated chronic hepatitis B patients. Oral 0.5 mg antiviral drug treatment for at least 1 year

Exclusion criteria

Exclusion criteria: Exclude superinfection with other viruses other than HBV; exclude other liver diseases (autoimmune liver disease, schistosomiasis cirrhosis, tumors, etc.); exclude patients with decompensated liver cirrhosis; exclude CHB patients with incomplete baseline data of antiviral therapy in the conversion plan.

Design outcomes

Primary

MeasureTime frame
HBV DNA;

Secondary

MeasureTime frame
HBeAg;HBsAg;HBcAb;Adverse events;

Countries

China

Contacts

Public ContactPan Xiucheng

The Affiliated Hospital of Xuzhou Medical University

xzpxc68@126.com+86 18052268129

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026