Entecavir Therapy for up to 96 Weeks in HBeAg positive chronic hepatitis B patients with high viral load

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OCH-12001951

Enrollment

Unknown

Registered

2012-02-17

Start date

2008-11-17

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Chronic Hepatitis B

Interventions

High viral load:Entecavir

Low viral load:Entecavir

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: positive reading for hepatitis B surface antigen (HBsAg) for at least 6 months; positive reading for hepatitis E antigen (HBeAg); serum HBV DNA load above 1*10^5 copies/ml at baseline; had ALT levels between 2 and 10 times the upper normal level (UNL) and meeting the general indications for antiviral therapy, as recommended by the Chinese Society of Hepatology.

Exclusion criteria

Exclusion criteria: presence of serum antibodies against hepatitis C virus (HCV), hepatitis A virus, hepatitis E virus, or human immunodeficiency virus (HIV); breastfeeding, pregnancy, or inadequate contraceptive measures; substance abuse in the previous 2 years; other acquired or inherited causes of liver disease; serious concomitant disease; and advanced liver disease (including decompensated cirrhosis with ascites, severe hepatitis, and hepatic carcinoma).

Design outcomes

Primary

Measure	Time frame
Entecavir;ALT;HBeA;	—

Secondary

Measure	Time frame
Safety;Resistance;	—

Contacts

Public ContactHong Tang

thong6198@hotmail.com+86 18980601313

Outcome results

None listed

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