The Relationship Between Long-term Oral Anti Hepatitis B Nucleoside Analogs and Hepatic Steatosis

NCT05416008 | Unknown DMC

• 1 other identifier: Zhangdz2021
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Steatosis

Outcome Measures

Primary Outcomes (3)

• Abdominal color Doppler ultrasound (if necessary CT or MR)

  Patients with fatty liver were evaluated by abdominal color Doppler ultrasound

  once a year up to 3 years

• Liver transient elastography

  The CAP value was obtained from the liver transient elastography. According to the CAP value, steatosis is divided into mild (CAP 248-267 dB / m), moderate (CAP 268-279 dB / m) and severe (≥ 280 dB / m).

  once a year up to 3 years

• Lipid profiles

  Lipid profiles, such as total cholesterol (TC), triglycerides(TG), high-density lipoprotein cholesterol(HDL-C), and low-density lipoprotein cholesterol(LDL-C).

  once a year up to 3 years

Study Arms (3)

Group 1: treatment with ETV

The patients in this group were composed of patients with chronic hepatitis B who firstly take entecavir for the treatment of chronic hepatitis B. Take Entecavir capsule orally for a long time, once a day, 0.5mg each time.

Group 2: treatment with TAF

The patients in this group were composed of patients with chronic hepatitis B who firstly take Tenofovir alafenamide Fumarate for the treatment of chronic hepatitis B. Take Tenofovir alafenamide Fumarate tablets orally for a long time, 25mg once a day.

Group 3: treatment with TDF

The patients in this group were composed of patients with chronic hepatitis B who firstly take Tenofovir disoproxil Fumarate for the treatment of chronic hepatitis B. Tenofovir disoproxil fumarate was orally administered for a long time, once a day, 300mg each time.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hepatitis B patients who meet the inclusion conditions and don't meet the exclusion conditions.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Dazhi Zhang, Doctor

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 13, 2022
• Study Start: July 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2025
• Last Updated: June 13, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)