CHB patients with advanced fibrosis
Conditions
Interventions
100mg dose group:flufenidone,100mg + tenofovir alafenamide fumarate, 25mg
200mg dose group:flufenidone, 200mg + tenofovir alafenamide fumarate, 25mg
300mg dose group:flufenidone, 300mg + tenofovir alafenamide fumarate, 25mg
Control group:flufenidone simulants + tenofovir alafenamide fumarate, 25mg
Sponsors
Beijing Friendship Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects not receiving NAs treatment currently: (1) Male or female between the ages 18 and 65 years (inclusive); (2) CHB infection, defined as HBsAg positive for >=6 months; (3) NAs treatment-naive, or without NAs treatment 6 months before signing the informed consent form (ICF); (4) HBV-DNA levels >= low limit of detection (according to test methods in each center); (5) Liver histology shows Ishak fibrosis stage 3-5 (inclusive); (6) ALT =6 months; (3) Receiving NAs treatment stable for>=3 months; (4) HBV-DNA level<= 2E3IU/ml; (5) With liver histology shows Ishak fibrosis stage 3-5 (inclusive); (6) ALT < 5*ULN; (7) Agreement to undergo liver biopsy before and after treatment (Subjects who have undergone liver histopathological examinations within 6 months before signing ICF are exempt from liver biopsy at screening) (8) Willing to follow-up regularly; (9) Having the ability to communicate with medical staff normally and abide by relevant hospital regulations; (10) Willing and able to sign ICF approved by Bioethics Committee and comply with all trial requirements.
Exclusion criteria
Exclusion criteria: 1. Being allergic to the main ingredients or any of the ingredients of the investigational drug or have a history of severe allergy; 2. History of sensitivity to light; 3. With evidence of liver cancer by imaging or AFP>50ng/ml at screening; 4. Decompensated cirrhosis who develop ascites, hepatic encephalopathy, esophageal varices bleeding, etc; 5. With concurrent liver diseases including alcoholic liver disease, non-alcoholic fatty liver disease, severe hepatic steatosis, drug-induced liver injury, autoimmune liver disease, hereditary liver disease and active hepatitis caused by other reasons except HBV infection; 6. Combination with other malignant tumors (excluding those who have no recurrence within 5 years after being cured); 7. With severe conditions of cardiovascular, pulmonary, endocrinegastrointestinal, hematologic, urinary, neurologic, or psychiatric illness (eligibility conformed by the investigator); 8. Having treated with immunomodulators [including but not limited to interferon (pegylated interferon or non- pegylated interferon) and thymosin] within 6 months prior to initial administration; 9. Having treated with anti-fibrosis drugs (including but not limited to: compound Biejia Ruangan Tablet, Fuzheng Huayu Tablet, Anluo Huaxian Pill) regularly for more than 3 months within 6 months prior to initial administration; 10. Platelet (PLT) count 1.5 ULN; 12. Glomerular filtration rate (GFR) = 30kg/m2; 14. Poor control of diabetes (HbA1c>8%); 15. Positive for hepatitis C antibody, HIV antibody or syphilis non-specific antibody; 16. Having participated in other clinical trials and taken the investigational drug within 3 months before signing ICF; 17. With alcohol, drug or substance abuse; 18. Alcohol consumption is considered by the investigator to affect compliance; 19. Female subjects in pregnancy, lactation or planned pregnancy; 20. Fertile subjects who cannot guarantee to take effective contraceptive measures within at least 3 months after signing ICF to the last use of the investigational drug; 21. Not suitable for this study identified by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ishak fibrosis score; | — |
Secondary
| Measure | Time frame |
|---|---|
| PIR Classification;Liver stiffness;HBV-DNA Quantitative detection;HBV serological markers detection;Liver biochemistry;Safety index;Exploratory index; | — |
Countries
China
Contacts
Public ContactJia Jidong
Beijing Friendship Hospital, Capital Medical University
Outcome results
None listed