Treatment and Prognosis of Patients With Chronic HBV Infection
ConditionHepatitis B Virus Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-79
SponsorXiangya Hospital of Central South University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Standard antiviral therapy
Other interventionpegylated interferon or/and nucleos(t)ide analogues
Treatment groups
500 Participants
are divided into 3 treatment groupsGroup A: peg-IFN-alpha alone1 intervention
Group B: nucleos(t)ide analogues alone1 intervention
Group C: combination1 intervention
Trial outcomes
Primary outcomes
1
virological response
serum HBV DNA level below the detection limit
Time frame
3 years2
HBeAg seroconversion
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
Time frame
3 years3
Clinical cure
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
Time frame
3 yearsSecondary outcomes
1
HBV DNA
The serum HBV DNA level will be detected and reported every 3 to 6 months
Time frame
3 years2
HBV serological test
HBV serological markers include HBsAg, anti-HBs, HBeAg, anti-HBe, hepatitis B core antibody (anti-HBc) were detected and reported every 3 months
Time frame
3 years3
liver function
The serum levels of transaminase including ALT and aspartate aminotransferase (AST) will be collected and reported every 3 months
Time frame
3 years4
Alpha-fetoprotein (AFP)
The serum AFP level will be detected and reported every 3 to 6 months
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov