Chronic HBV Infection
Conditions
Keywords
Chronic HBeAg positive HBV Infection
Brief summary
The experiment is divided into two parts: Part 1 and Part 2.Part 1 was the initial treatment patient and Part 2 was the treated patient.
Detailed description
About 125 subjects were planned to be included and assigned to the experimental group and the control group according to 4:1.At the same time, a liver biopsy group was set up in each part of the population to receive liver biopsy during the screening period and 48 weeks after completion of drug administration, which was used to detect HBV DNA, cccDNA, HBsAg, and evaluate the degree of liver inflammation and fibrosis.
Interventions
Sponsors
Sunshine Lake Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Chronic HBV infection population * HBeAg positive * HBsAg≥250 IU/mL * No cirrhosis
Exclusion criteria
* AST\>5×ULN * Platelet count less than 90E+09/L * TBil\>1.5×ULN * albumin\<35 g/L * INR\>1.5 * AFP\>50 ng/mL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The value of serum HBsAg decreased from baseline | 48 weeks after dosing | The value of serum HBsAg at 48 weeks of treatment was lowered compared with baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The value of serum HBeAg decreased from baseline | 48 weeks after dosing | The value of serum HBeAg at 48 weeks of treatment was lowered compared with baseline. |
| The value of HBV DNA decreased from baseline | 48 weeks after dosing | The value of HBV DNA at 48 weeks of treatment was lowered compared with baseline. |
| The value of serum HBsAg decreased from baseline | 24 weeks after dosing | The value of serum HBsAg at 24 weeks of treatment was lowered compared with baseline. |
Countries
China
Outcome results
None listed