The Optimizing Treatment of Peginterferon Alpha in Chronic Hepatitis B Patients With Low Level HBsAg
Status:
Unknown status
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
HBeAg-negative chronic hepatitis B (CHB) patients with low Level HBsAg were enrolled. After
giving informed consent, patients were treated with nucleoside analog(s) (NAs) once a day and
weekly subcutaneous injections of peginterferon alfa-2a 180 micrograms/week or peginterferon
alfa-2b 180 micrograms/week for 12 weeks. At week 12, the decrease of HBsAg was evaluated.
①If the decrease of HBsAg is more than 50% compared to baseline level. NAs was stopped,
patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or
peginterferon alfa-2b 180 micrograms/week. Treatment endpoint was HBsAg loss(<0.05 IU/ mL).
Depending on the decline of HBsAg level, treatment was either continued for a prolonged
period (no more than 96 weeks) until the endpoint was achieved, or terminated in week 96.
After treatment, all patients were followed up for 48 weeks.
②If the decrease of HBsAg is less than 50% compared to baseline level. The combination
therapy of NAs and peginterferon alfa was extended to week 24. Then, the decrease of HBsAg
was evaluated again.
If the decrease of HBsAg is more than 50% compared to baseline level. NAs was stopped,
patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or
peginterferon alfa-2b 180 micrograms/week. Treatment endpoint was HBsAg loss(<0.05 IU/mL).
Depending on the decline of HBsAg level, treatment was either continued for a prolonged
period (no more than 96 weeks) until the endpoint was achieved, or terminated in week 96.
After treatment, all patients were followed up for 48 weeks.
If the decrease of HBsAg is less than 50% compared to baseline level. Peginterferon alfa was
stopped, patients were treated with NAs once a day and then followed up for 48 weeks.
Patients who maintained the original NAs treatment served as a control group.