Status:
UNKNOWN
The Optimizing Treatment of Peginterferon Alpha in Chronic Hepatitis B Patients With Low Level HBsAg
Lead Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsors:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 subcuta...
Detailed Description
It is estimated that more than 400 million people are infected with hepatitis B virus (HBV) globally. HBeAg-negative CHB patients with low Level HBsAg were enrolled in the out-patient department of Th...
Eligibility Criteria
Inclusion
- CHB patients who had received NAs for more than 12 months.
- Hepatitis B e antigen (HBeAg)-negative.
- Hepatitis B surface antigen (HBsAg) positive and \<1000 IU/mL.
- Hepatitis B virus DNA \<100 IU/mL.
Exclusion
- Patients with liver cirrhosis, Hepatocellular Carcinoma or alpha feto protein (AFP) \>2 upper limit of normal(ULN) 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 :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03801538
Start Date
January 1 2019
End Date
December 1 2020
Last Update
January 15 2019
Active Locations (1)
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1
Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630