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Discontinuation of oral antivirals in chronic hepatitis B: a cohort study

Discontinuation of oral antivirals in chronic hepatitis B: a cohort study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900020836
Enrollment
Unknown
Registered
2019-01-20
Start date
2016-01-01
Completion date
Unknown
Last updated
2019-01-28

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

Conditions

chronic hepatits B

Interventions

Case series:Nil

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 or above (including 18 years old when signing the informed consent) male and female; 2. Patients who were HBeAg positive at the beginning of oral antiviral therapy; 3. Patients who met the drug withdrawal criteria in the guidelines for the prevention and treatment of chronic hepatitis B (2015) in China; 4. Patients who can participate in regular follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients who have been treated with interferon antiviral therapy. 2. Patients who have been treated with immunomodulators such as thymosin and glucocorticoid. 3. Patients with compensated cirrhosis, that means met at least 2 of the following 4 criteria: (1) Ultrasound, CT and other imaging examinations suggested one of the changes in liver cirrhosis: irregular liver surface, granule or nodular liver parenchyma, with or without splenomegaly (splenic thickness > 4.0cm or greater than 5 rib units); (2) Routine blood PLT 1.3 or longer than PT 3s (discontinued thrombolysis or anticoagulant for more than 7 days); (4) Determination of liver elasticity >12.4kPa (ALT100ng/ml and imaging indicated the possibility of malignant liver occupying, or AFP>100ng/ml for 3 months; 6. Patients with HCV or HIV infection were excluded. Patients who were combined with alcoholic liver disease, autoimmune liver disease, genetic metabolic liver disease, drug-induced liver disease, severe fatty liver disease and other chronic liver diseases were excluded; 7. Patients with other malignancies requiring chemotherapy or other diseases requiring immunomodulatory therapy; 8. Patients who are not fit for this study judged by investigators.

Design outcomes

Primary

MeasureTime frame
HBV RNA;HBV DNA;HBsAg/HBsAb;HBeAg/HBeAb;Liver function test;

Countries

China

Contacts

Public ContactLai Wei

Peking University People's Hospital

weelai@163.com+86 010-66583772

Outcome results

None listed

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