Treatment and Prognosis of Patients With Chronic HBV Infection
- Conditions
- Hepatitis B Virus Infection
- Interventions
- Other: Standard antiviral therapy
- Registration Number
- NCT05392387
- Lead Sponsor
- Xiangya Hospital of Central South University
- Brief Summary
Hepatitis B virus (HBV) infection is a major global health issue with 257 million chronically infected individuals. Of note, China has the largest population accounting for one third of the world's infected population. Approximately, about 300 000 people die each year due to the consequences of HBV. In 2016, the World Health Organization (WHO) proposed the goal for elimination of hepatitis B as public health threat by 2030 and China will be a major contributor towards this global goal. Currently, two approved therapeutic strategies are available including pegylated interferon (IFN) or nucleos (t) ide analogues (NA), which could suppress HBV replication and slow disease progression. Here, investigators hope to launch a cohort study to reveal the clinical features relating to therapeutic efficacy of antiviral therapy and the prognosis of patients with differential therapeutic strategies.
- Detailed Description
Patients with chronic HBV infection were recruited in the current study and divided in to peg-IFN-alpha alone group, NAs alone group and the combination therapy group. The serum HBV DNA level, HBV serological test and biochemical examination including serum transaminase level and AFP were recorded every three or six months. The serum, feces, urine and liver (if necessary) samples were collected during follow-up. And the clinical outcomes of patients were evaluated. The clinical and biological features of patients with different clinical outcomes will be compared to explore the factors affecting the antiviral therapeutic efficacy.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
patients with evidence of chronic HBV infection
chronic liver injury mainly caused by other reasons, such as autoimmune diseases, alcohol, drugs and so on.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description combination Standard antiviral therapy Patients with chronic HBV infection treated with nucleos(t)ide analogues and peg-IFN-alpha nucleos(t)ide analogues alone Standard antiviral therapy Patients with chronic HBV infection only treated with nucleos(t)ide analogues peg-IFN-alpha alone Standard antiviral therapy Patients with chronic HBV infection only treated with peg-IFN-alpha
- Primary Outcome Measures
Name Time Method virological response 3 years serum HBV DNA level below the detection limit
HBeAg seroconversion 3 years Loss of HBeAg and presence of anti-hepatitis B e antibody (anti-HBe) in a person who was previously HBeAg-positive and anti-HBe-negative
Clinical cure 3 years Sustained virological response and HBsAg clearance or with anti-HBs seroconversion, alanine aminotransferase (ALT) within the normal range, and mild or no lesions in the liver
- Secondary Outcome Measures
Name Time Method HBV serological test 3 years HBV serological markers include HBsAg, anti-HBs, HBeAg, anti-HBe, hepatitis B core antibody (anti-HBc) were detected and reported every 3 months
HBV DNA 3 years The serum HBV DNA level will be detected and reported every 3 to 6 months
Alpha-fetoprotein (AFP) 3 years The serum AFP level will be detected and reported every 3 to 6 months
liver function 3 years The serum levels of transaminase including ALT and aspartate aminotransferase (AST) will be collected and reported every 3 months
Trial Locations
- Locations (1)
Department of Infectious Disease, Xiangya Hospital, Central South University
🇨🇳Changsha, Hunan, China