Hepatitis B, Chronic Clinical Trial
Official title:
A Study on Optimizing HBsAg Clearance in CHB Patients With Sequential Treatment of Pegylated Interferon Alpha-2b and Nucleoside Analogues
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | The third affiliated hospital of Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Third Affiliated Hospital, Sun Yat-Sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HBsAg loss | Week 48 | No |
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