Clinical trial NCT05416008: The Relationship Between Long-term Oral Anti Hepatitis B Nucleoside Analogs and Hepatic Steatosis
Official title: A Prospective Observational Study on the Relationship Between Long-term Oral Anti Hepatitis B Nucleoside Analogs and Hepatic Steatosis
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hepatic Steatosis
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hepatitis B patients who meet the inclusion conditions and don't meet the exclusion conditions.

Brief summary: This study aims to investigate whether long-term use of nucleotide analogues could promote hepatic steatosis in patients with chronic hepatitis B. The degree of hepatic steatosis was observed after 3 years of antiviral treatment with nucleoside (acid) analogues for the first time to determine whether the long-term use of anti hepatitis B nucleoside (acid) analogues could promote hepatic steatosis. To explore the anti hepatitis B nucleotide analogues that can promote liver steatosis, so as to provide evidence-based medical evidence for the selection or adjustment of anti hepatitis B virus drugs in patients with chronic hepatitis B.

Detailed description: This is a single-center, prospective, observational study involving chronic hepatitis B patients from the Second Affiliated Hospital of Chongqing Medical University.

Research implementation process and route

Recruitment object: Patients with chronic hepatitis B, defined as persistent hepatitis B surface antigen positive for ≥ 6 months, (aged ≥ 18, treatment-naive ) were consecutively recruited for outpatient routine examination between July 2021 and December 2022. We excluded patients with prior history of hepatocellular carcinoma, concomitant hepatitis C virus or human immunodeficiency virus infection, primary biliary cirrhosis, Wilson's disease, autoimmune hepatitis, significant alcohol intake (≥ 30 g per day for male, or ≥ 20 g per day for female), on steatogenic medications, prior liver transplantation. The basic information and various examination indexes of the patients were collected, and the patients were informed that they needed to go to the outpatient clinic of our hospital for follow-up examination every 1 year, with a total follow-up of 3 years.

Data to be collected: general medical history characteristics: medical record number, name, gender, age, , enrollment time, contact information, and name of anti hepatitis B drugs. Examination and inspection indicators: liver function, renal function, blood chart analysis, blood lipid, hepatitis B two half and half, anti hepatitis C virus, anti hepatitis D virus, AIDS syphilis screening, high precision hepatitis B virus-DNA quantification, abdominal color Doppler ultrasound (if necessary CT or MR), transient elastography of the liver.

Follow up: after enrollment, the relevant examination indexes were rechecked every 1 year. The follow-up period was 3 years.

Statistical analysis: after a three-year follow-up, the data collected were tested by t-test and multivariate Cox analysis to analyze whether the long-term use of anti hepatitis B nucleoside (acid) analogues could promote hepatic steatosis.

Eligibility criteria: Inclusion Criteria:

* Willing and able to sign informed consent.
* Male or female.
* 18 ≤ age≤ 80.
* Clinical diagnosis of chronic hepatitis B.
* Has not received anti HBV treatment.

Exclusion Criteria:

* With prior history of HCC
* Concomitant HCV or HIV
* Primary biliary cholangitis
* Wilson's disease
* Autoimmune hepatitis
* Significant alcohol intake (≥ 30 g per day for male, or ≥ 20 g per day for female)
* Taking steatogenic medications
* Prior liver transplantation

Primary outcomes:
measure: Abdominal color Doppler ultrasound (if necessary CT or MR)
timeFrame: once a year up to 3 years
measure: Liver transient elastography
timeFrame: once a year up to 3 years
measure: Lipid profiles
timeFrame: once a year up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Dazhi Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: