Chronic hepatitis B
Conditions
Interventions
1:HS-10234 10 mg
1:TDF 300 mg
2:HS-10234 25 mg
2:TDF 300 mg
3:HS-10234 40 mg
3:TDF 300 mg
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Voluntary grouping, able to understand and sign informed consent, and complete the study in accordance with study protocol; (2) Subjects (including male subjects) are willing to take no pregnancy plans within the next 6 months and voluntarily take effective contraceptive measures; (3) 18-65 years of age, male or female; (4) Body mass index (BMI) in the range of 18 to 28; (5) Patients with chronic hepatitis B, chronic hepatitis B for at least 6 months by the judgement of physicians; (6) Not treated with nucleotide analogs within 6 months prior to screening, or has been treated with nucleotide analogs or interferon, but discontinued for more than 6 months; (7) blood test pregnancy should be negative for thewomen of childbearing risk; (8) HBV DNA is greater than 2x10^3 IU/mL; (9) Serum ALT is greater than 1.2 x ULN, and less than 10 x ULN; (10) Creatinine clearance (CLCr) is greater than or equal to 70 mL/min; (11) Urine protein negative or 1 + (need to do 24h urine protein quantitative when 1 +, if in the normal range, can be included).
Exclusion criteria
Exclusion criteria: (1) History of drug dependence or drug abuse; (2) Smokers (up to 10 cigarettes or more per day); (3) Alcoholics (more than 14 cups per week, each cup is equivalent to 360mL beer or 150mL wine or 45mL liquor); (4) Blood donation or blood loss = 400mL within 3 months before, or received blood transfusion; or blood donation or blood loss = 200mL within 1 month before screening; (5) A serious infection, trauma or surgery major surgery history within 4 weeks before screening; (6) Can not tolerate venipuncture blood or halo needle, halo history; (7) Combined with other liver disease in addition to hepatitis B patients, including chronic alcoholic hepatitis, drug-induced liver injury, autoimmune liver disease; (8) Gilbert syndrome and other hereditary liver disease patients; (9) Liver malignancy or other untreated malignant tumors before screening; (10) Chronic kidney disease, renal insufficiency; (11) Poor control of other important organs such as the nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolic and skeletal muscle system of a clear history (such as poor control of diabetes, high blood pressure, etc.) So that the researcher thinks it is not suitable for the participants; (12) Previous treatment of tenofovir dipivoxil fumarate treatment without responders; (13) Using other nucleoside (acid) or interferon treatment within 6 months before the screening; (14) With any prescription drugs or may affect hepatitis B virus replication of Chinese herbal medicine or withdrawal does not exceed the drug half of the half-life within the first week of enrollment, or taking the liver metabolic enzyme strong inhibitors and inducers within 4 weeks before enrollment; (15) Can not guarantee that from the first week of medication and throughout the test period, fasting dragon fruit, grapefruit, mango, carambola and fruit containing fruit and spicy food; (16) Participated in any drug or medical device clinical trial within 3 months before screening,; (17) Liver function decompensated patients with hepatitis B (Child-Pugh score of B or C); (18) Pregnancy, lactating women, or pregnancy test positive; (19) HCV antibody positive and HCV-RNA positive (PCR method); (20) HIV antibody positive, Treponema pallidum antibody positive; (21) Result of urine drug abuse screening test is positive, or of alcohol breath test screening is positive; (22) Any subjects who should not participate in this trial by the judgement of the invesitigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event;clinical lab results;PK parameters;HBV DNA;ALT/AST;HBsAg; | — |
Countries
China
Contacts
Public ContactNiu Junqi/Ding Yanhua
The First Hospital of Jilin University
Outcome results
None listed