Chronic Hepatitis B
Conditions
Interventions
1:Ganlong capsule and Entecavir
2:Ganlong capsule and Tenofovir
Sponsors
2nd People's Hospital Yunnan Province
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (I) Inclusion standards 1. Aged 18 years old or above male and female; 2. Determining diagnosis of chronic hepatitis B must conform to the following conditions: (1) HBV infection 6 months shall be proved before base line; (2) DNA level of HBV: patients with positive HBeAg, HBV DNA=20 000IU/ml (equal to 10^5 copies/ml); patients with negative HBeAg, HBV DNA=2000IU/ml (equal to =104 copies/ml); (3) ALT level: generally ALT is required to be risen continuously =2ULN; (4) Patients without accepting any treatment of interferon and nucleoside (acid) analogue (whether treatment time is long or short) within 6 months. 3. Non-cirrhosis patients: non-cirrhosis is defined as conforming to one of the following conditions: (1) liver biopsy within 1 year is proved to be non-cirrhosis before base line (Metavir fibrosis score =3 scores. For details of scoring methods see Appendix 1); (2) Fibro-Touch detection value of screening period =7.3kPa; (3) Fibro-Touch detection value of screening period >7.3kPa but =17.5kPa, then it needs to be proved to be non-cirrhosis (Metavir fibrosis score =3 scores) by liver biopsy. If result of liver biopsy is inconsistent with Fibro-Touch detection value, it shall be subject to result of liver biopsy. 4. Patients signing informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Positive subjects in one of anti-HAV (IgM), anti-HCV, anti-HEV (IgM), anti-HIV 2. Patients with Fibro-Touch detection value>17.5kPa (except those verified to be non-live cirrhosis patients in liver tissue biopsy); or patients examined to be live cirrhosis patients in histopathologic examination. 3. Patients with hepatopathy not caused by HBV (such as autoimmune liver disease, non-alcoholic fatty liver disease, alcoholic liver disease, drug-induced liver injury, WiLsons disease, a1 antitrypsin deficiency disease, hemochromatosis, etc.) as indicated by previous existing or present evidences 4. Patients with previous history of hepatocellular carcinoma or suspected to have hepatocellular carcinoma before screening or suspected to find hepatocellular carcinoma in color Doppler ultrasound inspection at the time of screening, or AFP>100ng/ml at the time of screening. 5. BMI32kg/m2. 6. ANC1.5; Cr>1.5ULN; 7. Patients with or once with mental disease in nervous system and/or mental system, poor self-control, and disability to exactly express intention; 8. Patients with existing serious CVD not controlled well (such as ventricular fast arrhythmia, myocardial infarction, angina, CAD, etc.); patients with existing high blood pressure not controlled well (systolic pressure=160mmHg and/or diastolic pressure=100mmHg); or patients with abnormal ECD examination results with clinical significance; 9. Patients with serious diseases in respiratory system and urinary system; 10. Patients who have received solid organ transplantation or corneal transplantation or bone marrow transplantation, or are planned to receive organ transplantation during this clinical study; 11. Patients with diabetes (glycosylated hemoglobin>7.0%) not controlled well or diseases in other endocrine system; 12. Patients with serious hematological system diseases or increased anemia (such as thalassemia, sickle cell anemia, spherocyte disease, gastrointestinal bleeding); 13. Patients with malignant tumor in medical history within 5 years before screening or patients who are suspected to have malignant tumor; 14. Patients with gastrointestinal disturbance or post-operation disease which may interfere with absorption of experimental drugs; 15. Patients who need to take the following drugs from the time of signing informed consent to termination of treatment: (1) CYP3A4 inducer (such as rifampicin and phenobarbital) and CYP3A inhibitor (such as voriconazole) of hepatic microsomal enzyme; (2) OATP inhibitor (such as cyclosporine and rifampicin) or substrate (such as rosuvastatin); (3) Drugs with narrow therapeutic window and substrates which allows CYP3A extensive metabolism and/or transfer of p glycoprotein (such as astemizole, ergometrine, cisapride, pimozide, midazolam, triazolam, atorvastatin, lovastatin, simvastatin and fluticasone propionate); (4) Hormonal contraceptive; (5) Resinae drugs which integrates probenecid and bile acid; (6) Immunosuppressive drug; (7) Drugs with cytotoxic effect or chemotherapy drugs; (8) Antiarrhythmic drugs (such as amiodarone, bepridil, flecainide, propafenone and quinindium); (9) Corticosteroid drugs (except some drugs for local medication); (10) PDE5 inhibitor (such as sildenafil, tadalafil and vardenafil). 16. Patients who donate blood or lose more than 400ml blood within 2 months before base line; or patients who receive treatment of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV DNA negative conversion rate, HBeAg negative conversion rate or serologic conversion rate as well as ALT normalization rate 96 weeks after treatment.; Changes in count of CD4+/CD8+ T lymphocyte subpopulation. ; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBV DNA negative conversion rate, HBeAg negative conversion rate or serologic conversion rate as well as ALT normalization rate 24/48/72 weeks after treatment.;HBeAg negative conversion rate and serologic conversion rate 24/48/72/96 weeks after treatment.;Continuous response rate of virus, accumulative negative conversion rate or serologic conversion rate of HBeAg as well as accumulative negative conversion rate or serologic conversion rate of HBsAg 48 weeks after treatment.;Changes in HBV DNA from base line with the time.; | — |
Countries
China
Contacts
Public ContactWEI JIA
The 2nd People's Hospital Yunnan Province
Outcome results
None listed