Hepatitis B
Conditions
Interventions
Case series:Treatment Withdrawal
Sponsors
302th Military Hospital of PLA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HBeAg– CHB with at least 4 years of complete viral suppression (DNA<500 IU/ml) on NA therapy; 2. Normal liver tests and platelet count; 3. Aged 18-67 years; 4. Otherwise healthy with no serious co-morbidities or co-existing liver disease.
Exclusion criteria
Exclusion criteria: 1. HBeAg– CHB with virologic breakthrough while on NA therapy during the prior 4 years; 2. Significant co-morbidities including co-infection, co-existing liver disease or anemia; 3. Stage 2 fibrosis or greater (on a 0-4, Metavir fibrosis scale); 4. ALT above the quoted normal range (ALT>40 U/L); 5. Clinical, serologic or biochemical suspicion for cirrhosis; 6. Prior liver transplantation; 7. A documented history of extrahepatic manifestations of hepatitis B, including renal disease and/or vasculitis; 8. A history of resistance to nucleotide (eg. Adefovir) and/or nucleoside (eg. Lamivudine) analogs; 9. A history of HCC; 10. On Prednisone or other immunosuppressive or immune-modulating therapy during the 6 months before study entry; 12. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBVDNA; | — |
Countries
China
Contacts
Public ContactYINJIE GAO
302th Military Hospital of PLA
Outcome results
None listed