Clinical trial NCT05392387: Treatment and Prognosis of Patients With Chronic HBV Infection
Official title: Study on the Antiviral Therapy and Prognosis of Patients With Chronic HBV Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis B Virus Infection
Keywords: Hepatitis B Virus Infection
antiviral therapy
prognosis
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The chronic HBV-infected patients with differential antiviral strategies were recruited and separated to peg-IFN-alpha alone, NAs alone or combination treatment groups according to their antiviral therapies. The clinical outcomes of patients with differential treatments were compared during the follow-up management.

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.

Eligibility criteria: Inclusion Criteria:

patients with evidence of chronic HBV infection

Exclusion Criteria:

chronic liver injury mainly caused by other reasons, such as autoimmune diseases, alcohol, drugs and so on.

Primary outcomes:
measure: virological response
timeFrame: 3 years
measure: HBeAg seroconversion
timeFrame: 3 years
measure: Clinical cure
timeFrame: 3 years
Secondary outcomes:
measure: HBV DNA
timeFrame: 3 years
measure: HBV serological test
timeFrame: 3 years
measure: liver function
timeFrame: 3 years
measure: Alpha-fetoprotein (AFP)
timeFrame: 3 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Department of Infectious Disease, Xiangya Hospital, Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Yan Huang
role: STUDY_DIRECTOR
References: