Hepatitis B Virus Clinical Trial
— ALTHBVOfficial title:
Study on Therapeutic Effects and Safety of Nucleoside (Acid) Analogues Treatment in Patients With Chronic Hepatitis B With Normal Alanine Aminotransferase and Positive Hepatitis B Virus DNA: a Randomized Controlled Trial
NCT number | NCT04231565 |
Other study ID # | PL10 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 4, 2020 |
Est. completion date | July 1, 2027 |
This study is to investigate the clinical efficacy and safety of Nucleoside (acid) analogues treatment in patients with normal Alanine Aminotransferase and positive Hepatitis B virus DNA.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | July 1, 2027 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Positive hepatitis b surface antigen and hepatitis b antibody > 0.5 year; - Age from 18 to 65 years old; - Serum Alanine Aminotransferase(ALT) =1×ULN at least 12 weeks; - Positive Hepatitis b virus(HBV); - Do not receive nucleotide/nucleoside analogues or interferon treatment in the past half year. Exclusion Criteria: - Other active liver diseases; - Hepatocellular carcinoma or other malignancy; - Pregnancy or lactation; - Human immunodeficiency virus infection or congenital immune deficiency diseases; 5.Severe diabetes, autoimmune diseases; 6.Other important organ dysfunctions; 7.Using glucocorticoid; 8.Patients can not follow-up; 9.Investigator considering inappropriate. |
Country | Name | City | State |
---|---|---|---|
China | 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 | hepatitis b s antigen decrease from baseline | Magnitude of decrease in hepatitis B antigen quantification from baseline to week 144. | 48 week, 96 week, 144 week | |
Secondary | hepatitis b e antigen loss rate | Hepatitis b e antigen would be tested to know the ratio of patients with negative hepatitis B e antigen. | 48 week, 96 week, 144 week | |
Secondary | hepatitis b virus(HBV) DNA undetectable rate | Hepatitis b virus DNA would not be detected if it below the upper limit of test value | 48 week, 96 week, 144 week | |
Secondary | hepatitis b virus(HBV) RNA undetectable rate | Hepatitis b virus RNA would not be detected if it below the upper limit of test value | 48 week, 96 week, 144 week | |
Secondary | hepatitis b s antigen loss rate | Hepatitis b s antigen become negative and quantitative analysis below the upper limit of test value | 48 week, 96 week, 144 week |
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