Chronic Hepatitis B Infection Clinical Trial
Official title:
Cohort Study of Clinical Outcomes in Chronic HBV Infection Patients With Low HBsAg Loads Under Unplanned Intervention
All chronic hepatitis B (CHB) patients were diagnosed and treated in the liver disease department of the Hepatology Center of Beijing Ditan Hospital affiliated to Capital Medical University and those who received antiviral therapy (interferon and nucleoside analogues) reached HBsAg<100 IU/ml. The enrolled subjects were divided into the following six observation cohorts: 1) CHB patients in the immunological control period, without any clinical treatment intervention; 2) After interferon therapy, HBsAg<100 IU/ml, continued interferon therapy; 3) After interferon therapy, HBsAg<100 IU/ml, stopped interferon treatment; 4) After interferon therapy, HBsAg<100 IU/ml, sequential nucleoside analog treatment; 5) After nucleoside analogue treatment, HBsAg<100 IU/ml, sequential interferon treatment; 6) After treated with nucleoside analogues, HBsAg<100 IU/ml, continuing the nucleoside analog treatment. The follow-up observation period was 96 weeks under non-planned intervention. During the observation period, HBV indicators and biochemical indicators, serum AFP and liver imaging (liver ultrasound) were examined regularly. The main evaluation index was the incidence of HBsAg disappearance during the observation period. Secondary evaluation indicators: the rate of HBV DNA turning positive, the rate of HBeAg turning positive and hepatitis incidence. To observe the inactive carrier status of low HBsAg content and the incidence of HBsAg disappearance, clinical outcomes and influencing factors in patients with CHB under different antiviral interventions.
This study is a clinical observational cohort study. All chronic hepatitis B patients were diagnosed and treated in the liver disease department of the Hepatology Center of Beijing Ditan Hospital affiliated to Capital Medical University and those who received antiviral therapy (interferon and nucleoside analogues) reached HBsAg<100 IU/ml. The enrolled subjects were divided into the following six observation cohorts: 1) chronic Hepatitis B patients in the immunological control period, without any clinical treatment intervention in this cohort; 2) After interferon therapy, HBsAg<100 IU/ml, continued interferon therapy in this cohort; 3) After interferon therapy, HBsAg<100 IU/ml, stopped interferon treatment in this cohort; 4) After interferon therapy, HBsAg<100 IU/ml, sequential nucleoside analog treatment in this cohort; 5) After nucleoside analogue treatment, HBsAg<100 IU/ml, sequential interferon treatment in this cohort; 6) After treated with nucleoside analogues, HBsAg<100 IU/ml, continuing the nucleoside analog treatment in this cohort. The follow-up observation period was 96 weeks under non-planned intervention. During the observation period, HBV DNA loads, HBsAg/anti-HBs, HBeAg/anti-HBe and biochemical indicators, serum AFP and liver imaging (liver ultrasound) were examined regularly. The main evaluation index was the incidence of HBsAg disappearance during the observation period. Secondary evaluation indicators: the rate of HBV DNA turning positive, the rate of HBeAg turning positive and hepatitis incidence. To observe the inactive carrier status of low HBsAg content and the incidence of HBsAg disappearance, clinical outcomes and influencing factors in patients with CHB under different antiviral interventions. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03329820 -
Quality of Life and Health Utility of Patients With CHB Infections
|
N/A | |
| Recruiting |
NCT03210506 -
The Changes of Cytokines During Antiviral Therapy
|
N/A | |
| Recruiting |
NCT03209011 -
The Changes of CD4+T Cells Frequency and Function During Antiviral Therapy
|
Phase 4 | |
| Recruiting |
NCT03210467 -
The Changes of Plasmacytoid Dendritic Cells Frequency and Function During Antiviral Therapy
|
N/A | |
| Recruiting |
NCT03210493 -
The Changes of Treg Cells Frequency and Function During Antiviral Therapy
|
N/A | |
| Recruiting |
NCT03209037 -
The Changes of CD8+T Cells Frequency and Function During Antiviral Therapy
|
Phase 4 | |
| Recruiting |
NCT03208998 -
The Changes of Natural Killer Cells Frequency and Function During Antiviral Therapy
|
Phase 4 | |
| Recruiting |
NCT04638439 -
The Safety and Efficacy of Sequential Treatment of Ropeginterferon Alfa-2b (P1101) and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D Infection
|
Phase 1 | |
| Recruiting |
NCT03587467 -
Study on Gut Microbiota in Chronic HBV Infected Patients
|
||
| Completed |
NCT05355467 -
Efficacy and Safety of Ricovir® in Maintaining Durability of Viral Response in Chronic Hepatitis B Patients Who Have Been Treated With Viread® and Have Undetectable HBV DNA in Serum
|
Phase 4 | |
| Recruiting |
NCT04135235 -
Effect and Safety of Propofol Fumarate for Mother-to-child Blocking of Hepatitis B
|