Hepatitis B, Chronic
Conditions
Keywords
Chronic hepatitis B, Peginterferon alfa-2b, Nucleotide analogue
Brief summary
As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with sequential treatment of pegylated interferon alpha-2b and NAs.
Detailed description
CHB Patients who had received, and responded to, NAs for more than 12 months are switched to receive peginterferon alfa-2b 80 micrograms/week for 48 weeks and follow up for 48 weeks.
Interventions
DRUGPeginterferon alfa-2b
peginterferon alfa-2b 80 micrograms/week for 48 weeks
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. CHB patients who had received NAs for more than 12 months. 2. Hepatitis B e antigen (HBeAg)-negative and anti-HBeAg positive. 3. Hepatitis B surface antigen (HBsAg) positive and \<1500 IU/mL. 4. Hepatitis B virus DNA not detectable.
Exclusion criteria
1. Patients with liver cirrhosis, Hepatocellular Carcinoma or other malignancies. 2. Patients with other factors causing liver diseases. 3. Pregnant and lactating women. 4. Patients with concomitant HIV infection or congenital immune deficiency diseases. 5. Patients with diabetes, autoimmune diseases. 6. Patients with important organ dysfunctions. 7. Patients with serious complications ( e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding. ) 8. Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months. 9. Patients who can't come back to clinic for follow-up on schedule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg loss | Week 48 |
Countries
China
Contacts
Primary ContactXiang Zhu, Doctor
Outcome results
None listed