Status:
UNKNOWN
The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg
Lead Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsors:
Peking University
Huazhong University of Science and Technology
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 tre...
Detailed Description
In order to optimize HBsAg clearance in CHB patients with low level HBsAg, the investigators enrolled patients who had received, and responded to, NAs for more than 12 months(see the inclusion criteri...
Eligibility Criteria
Inclusion
- CHB patients who had received NAs for more than 12 months.
- Hepatitis B e antigen (HBeAg)-negative and anti-HBeAg positive.
- Hepatitis B surface antigen (HBsAg) positive and \<1500 IU/mL.
- Hepatitis B virus DNA not detectable(Roche Cobas).
Exclusion
- Patients with liver cirrhosis, Hepatocellular Carcinoma or other malignancies.
- Patients with other factors causing liver diseases.
- Pregnant and lactating women.
- Patients with concomitant HIV infection or congenital immune deficiency diseases.
- Patients with diabetes, autoimmune diseases.
- Patients with important organ dysfunctions.
- Patients with serious complications (e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding.)
- Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months.
- Patients who can't come back to clinic for follow-up on schedule.
Key Trial Info
Start Date :
April 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2019
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02745704
Start Date
April 1 2016
End Date
April 1 2019
Last Update
January 15 2019
Active Locations (1)
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1
The third affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630