Chronic Hepatitis B
Conditions
Interventions
Task One: Monotherapy with NAs group:Monotherapy with NAs
Task One: Combination Therapy of NAs with Peg IFNa-2b group:Combination Therapy of NAs with Peg IFNa-2b
Task Two: Monotherapy with NAs group:Monotherapy with NAs
Task two: Combination Therapy of NAs with Peg IFNa-2b group:Combination Therapy of NAs with Peg IFNa-2b
Task Three: Peg IFNa-2b Group group:Peg IFNa-2b treatment
Task Three: PD-1 Antibody Group group:PD-1 Antibody treatment
Task Three: Combination Group of Peg IFNa-2b and PD-1 Antibody group:Combination Treatment of Peg IFNa-2b and PD-1 Antibody
Sponsors
Beijing You'an Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Task One: Multicenter Clinical Study of Antiviral Therapy for Chronic Hepatitis B in Adults in Immune Clearance Phase a Age: 18-65 years old; b In accordance with the 2022 "Guidelines for the Prevention and Treatment of Chronic Hepatitis B," chronic HBV infection is defined as HBsAg and/or HBV DNA positive for >6 months; c Immune clearance phase: HBeAg positive, HBV DNA positive, ALT >40U/L; d Treatment-naïve patients; e Willing to sign informed consent. Task Two: Multicenter Clinical Study of Antiviral Therapy for Chronic Hepatitis B in Adults in Immune Tolerant Phase a Age: 18-65 years old; b In accordance with the 2022 "Guidelines for the Prevention and Treatment of Chronic Hepatitis B," chronic HBV infection is defined as HBsAg and/or HBVDNA positive for >6 months; c Immune tolerant phase: HBsAg >10000IU/ml, HBeAg positive, HBVDNA >2×10^7IU/ml, ALT =40U/L; d Treatment-naive patients; e Willing to sign informed consent. Task Three: Clinical Study of Combined Novel Immunotherapy and Antiviral Therapy in Adults with Chronic Hepatitis B Who Have Achieved Treatment Dominance with Nucleos(t)ide Analogues (NAs) a Age: 18-65 years old; b In accordance with the 2022 "Guidelines for the Prevention and Treatment of Chronic Hepatitis B," chronic HBV infection is defined as HBsAg and/or HBVDNA positive for >6 months; c NAs treatment-dominant population: Treated with NAs for over 1 year, HBV DNA negative, HBeAg negative, and 200IU/ml < HBsAg < 1500 IU/ml; d Willing to sign informed consent.
Exclusion criteria
Exclusion criteria: Tasks One and Two: a Patients with concomitant infections of HAV, HCV, HEV, or autoimmune liver diseases; b Pregnant or lactating women and patients planning pregnancy in the near future; c Patients with imaging or liver stiffness testing indicating cirrhosis or liver cancer; d Patients with a history of severe heart disease, including unstable or uncontrolled heart disease within the past 6 months; e Patients with a history of mental illness or psychiatric disorders; f Patients with uncontrolled epilepsy; g Patients who have not discontinued alcohol abuse or drug use; h Patients with uncontrolled diabetes, hypertension, thyroid disorders, retinal diseases, autoimmune diseases, etc. Task Three: a Patients with concomitant infections of HAV, HCV, HDV, HEV, or autoimmune liver diseases; b Pregnant or lactating women and patients planning pregnancy in the near future; c Patients with a history of severe heart disease, including unstable or uncontrolled heart disease within the past 6 months; d Patients with a history of psychiatric disorders; e Patients with uncontrolled epilepsy; f Patients who have not discontinued alcohol abuse or drug use; g Patients with uncontrolled diabetes, hypertension, thyroid disorders, retinal diseases, autoimmune diseases, etc.; h Total bilirubin >34umol/L; i Patients with a history of or currently diagnosed with cirrhosis or liver cancer confirmed by liver ultrasound or liver stiffness measurement; j Neutrophil count <2×10^9 /L and/or platelet count <100×10^9 /L.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBV DNA;HBeAg;HBcrAg;pgRNA;Hepatitis B core antibody; | — |
Countries
China
Contacts
Public ContactZheng Sujun
Beijing You'an Hospital, Capital Medical University
Outcome results
None listed