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

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ClinicalTrials.gov Identifier: NCT05416008
Recruitment Status : Enrolling by invitation
First Posted : June 13, 2022
Last Update Posted : June 13, 2022
Sponsor:
Information provided by (Responsible Party):
The Second Affiliated Hospital of Chongqing Medical University

Study Description
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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.

Condition or disease
Hepatic Steatosis

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study on the Relationship Between Long-term Oral Anti Hepatitis B Nucleoside Analogs and Hepatic Steatosis
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Abdominal color Doppler ultrasound (if necessary CT or MR) [ Time Frame: once a year up to 3 years ]
    Patients with fatty liver were evaluated by abdominal color Doppler ultrasound

  2. Liver transient elastography [ Time Frame: once a year up to 3 years ]
    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).

  3. Lipid profiles [ Time Frame: once a year up to 3 years ]
    Lipid profiles, such as total cholesterol (TC), triglycerides(TG), high-density lipoprotein cholesterol(HDL-C), and low-density lipoprotein cholesterol(LDL-C).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hepatitis B patients who meet the inclusion conditions and don't meet the exclusion conditions.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05416008


Locations
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China, Chongqing
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing, China, 400000
Sponsors and Collaborators
The Second Affiliated Hospital of Chongqing Medical University
Investigators
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Principal Investigator: Dazhi Zhang, Doctor The Second Affiliated Hospital of Chongqing Medical University
More Information
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Responsible Party: The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT05416008    
Other Study ID Numbers: Zhangdz2021
First Posted: June 13, 2022    Key Record Dates
Last Update Posted: June 13, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no sharing plan

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis B
Fatty Liver
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
 Communicable Diseases
Infections
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human