Status:
UNKNOWN
An Experimental Study on the Effect of Tenofovir Amibufenamide on Blood Lipid During Anti-HBV Treatment
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Hepatitis B, Chronic
Lipid Disorder
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
In June 2021, Chinese Food and Drug Administration approved the launch of the self-developed new drug Tenofovir Amibufenamide(TMF). TMF is a new second generation of tenofovir(TFV) and its effect on b...
Detailed Description
In June 2021, Chinese Food and Drug Administration approved the launch of the self-developed new drug Tenofovir Amibufenamide(TMF). TMF is the phosphoramidite precursor of Tenofovir, belonging to the ...
Eligibility Criteria
Inclusion
- Age 18-70 years old;
- Chronic hepatitis B patients who meet the CHB diagnostic criteria of "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (Chinese 2019 version)";
- HBV-DNA can be detected (≥20IU/mL);
- With or without liver cirrhosis caused by hepatitis B;
- The treatment plan is TMF antiviral therapy, and no other antiviral drugs are used for at least 1 year before;
- The clinical data are relatively complete, and the follow-up time reaches 24 weeks (6 months).
Exclusion
- Patients with primary liver cancer or liver metastases;
- Combined with hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus and human immunodeficiency virus infection;
- Combined with alcoholic liver disease, drug-induced liver disease, autoimmune liver disease and liver disease caused by other factors;
- History of treatment of dysglycemia and dyslipidemia;
- Patients with lactose intolerance;
- Pregnant women and lactating women;
- Patients with other serious systemic diseases.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05398393
Start Date
January 1 2022
End Date
June 30 2023
Last Update
June 1 2022
Active Locations (1)
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1
Wuhan Union hosipital
Wuhan, Hubei, China, 430022