Previous studies have shown that there are alterations in the number and affinity of interferon receptors during interferon therapy and that such alterations recover to varying degrees some time after the end of treatment. It can be conjectured that the rest period of pulsed therapy facilitates the recovery of type I interferon receptors and thus the next round of IFN therapy compared to a continuous regimen of interferon.
Age 18 to 60 years, both sexes (both 18 and 60 years)
HBsAg positive for more than 6 months;
NAs treated patients on continuous NA therapy for more than 6 months with HBsAg ≥ 1500 IU/ml and HBV-DNA < 500 IU/ml at enrolment;
Primary treated patients with surface antigen >1500 IU, unlimited E antigen and unlimited HBV DNA at enrolment, meeting the treatment indications of the 2019 edition of the guidelines for the prevention and treatment of chronic hepatitis B.
Combined active hepatitis A, C, D, E and/or HIV infection;
Patients who are on future and intend to continue to use tibivudine
methaemoglobin greater than 100ng/ml at screening; or methaemoglobin that has not remained stable for 3 months prior to the trial and/or liver imaging suggestive of liver tumours;
decompensated liver disease (Child-Pugh score ≥ 7), meaning that patients will be excluded if one of the following is met: prolonged prothrombin time ≥ 3 seconds, serum bilirubin > 34umol/L, history of hepatic encephalopathy, history of oesophageal variceal bleeding, ascites;
Parallel
PEGylated recombinant human interferon alpha-2b injection
DrugContinuous combination therapy: pegylated interferon alpha-2b 180µg, subcutaneously once a week for 96 weeks, combined with NAs throughout the treatment period.
PEGylated recombinant human interferon alpha-2b injection
DrugPulsed combination therapy: pegylated interferon alpha-2b 180µg once weekly by subcutaneous injection for 8 weeks with 4 weeks off for a total treatment duration of 96 weeks, combined with NAs throughout the treatment period.
HBsAg negative conversion rate after 96 weeks of treatment
After 96 weeks of treatment, 5 ml of blood will be drawn from the patient, serum will be extracted, and HBsAg values will be quantified by chemiluminescence assay; samples less than 0.5 ng/ml will be judged as negative.
HBsAb conversion rate after 96 weeks of treatment
After 96 weeks of treatment, 5 ml of blood will be drawn from the patient, serum will be extracted, and HBsAb values will be quantified by chemiluminescence; samples greater than 10 miu/ml 0.5 will be judged as positive.
Click on the lead sponsor to view all of their trials.
Anhui Medical University
Lead sponsor
The First Affiliated Hospital, University of Science and Technology of China
Collaborator
The Second Hospital of Anhui Medical University
Collaborator
Chaohu Hospital of Anhui Medical University
Collaborator
The First Affiliated Hospital of Bengbu Medical University
Collaborator
