Chronic Hepatitis B Clinical Trial
Official title:
HBsAg Loss/Seroconversion in Low Replicative Chronic HBV Infection Patients With Low Level HBsAg Treated With Peginterferon Alpha
Verified date | May 2018 |
Source | Third Affiliated Hospital, Sun Yat-Sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
HBsAg Loss/Seroconversion is uncommon in Low replicative chronic HBV infection patients. The purpose of this study is to investigate the ability of peginterferon alpha to achieve HBsAg loss/seroconversion therapy in Low replicative chronic HBV infection patients with Low Level HBsAg.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | September 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Hepatitis B surface antigen (HBsAg) positive and <1000 IU/mL. 2. Hepatitis B surface antibody (HBsAb) negative. 3. Hepatitis B e antigen (HBeAg) negative. 4. Hepatitis B virus DNA <2000 IU/mL. 5. Absence of previous antiviral therapy. Exclusion Criteria: 1. Patients with active alcohol and/or drugs consumption. 2. Patients with liver cirrhosis, Hepatocellular Carcinoma or other malignancies. 3. Patients with other factors causing liver diseases. 4. Pregnant and lactating women. 5. Patients with concomitant HIV infection or congenital immune deficiency diseases. 6. Patients with diabetes, autoimmune diseases. 7. Patients with important organ dysfunctions. 8. Patients with mental illness. 9. Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months. 10. Patients who can't come back to clinic for follow-up on schedule. |
Country | Name | City | State |
---|---|---|---|
China | Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Third Affiliated Hospital, Sun Yat-Sen University | First People's Hospital of Foshan, First People's Hospital, Shunde China, Huazhong University of Science and Technology, Huizhou Municipal Central Hospital, Nanchang University, Peking University, Shenzhen Third People's Hospital, Tang-Du Hospital, The First Affiliated Hospital of Kunming Medical College, Yuebei People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HBsAg Clearance Rate | Percentage of Participants with HBsAg negative. | 96 weeks | |
Secondary | HBsAg Seroconversion Rate | Percentage of Participants with HBsAg negative and anti-HBsAg positive | 96 weeks |
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