Hepatitis B Clinical Trial
— HBVOfficial title:
Study on Three Types of Nucleotide/Nucleoside Analogues Treatment in Patients With Hepatitis b Virus Related Acute-on-chronic Liver Failure
NCT number | NCT03920618 |
Other study ID # | PL6 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | February 1, 2019 |
Est. completion date | December 31, 2023 |
This study is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV-related acute-on-chronic liver failure.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 31, 2023 |
Est. primary completion date | October 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year; 2. Age from 18 to 55 years old; 3. Serum total bilirubin level > 10 times upper limit of normal; 4. Prothrombin time activity < 40% or prothrombin time international ratio > 1.5; 5. Do not receive nucleotide/nucleoside analogues treatment in the past half year. Exclusion Criteria: 1. Other active liver diseases; 2. Hepatocellular carcinoma or other malignancy; 3. Pregnancy or lactation; 4. 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 | Survival rate in the follow-up | Whether patients will survive after treatment is observed in the follow-up. | 144 week | |
Secondary | Model for end-stage liver disease (MELD) score is recorded after treatment | The calculation of model for end-stage liver disease (MELD) score is: R=0.378ln[serum total bilirubin (mg/dl)]+1.12ln(prothrombin time international normalized ratio)+0.95ln[serum creatinin(mg/dl)]+0.64. The higher the MELD score, the higher the mortality rate. MELD score is recorded after treatment. | 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week | |
Secondary | Ratio of patients with undetectable hepatitis b virus DNA after treatment | Hepatitis b virus DNA would be tested to know the ratio of patients with undetectable hepatitis b virus DNA at 7 time points after treatment. | 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week |
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