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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 blood lipids is unclear. Our study aims to figure out the effect of TMF on serum lipid level in the process of antiviral therapy for chronic hepatitis B patients.
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 nucleoside reverse transcriptase and owning higher cell membrane penetration rate, which make it easier to enter hepatocytes and achieve liver-targeted therapy. Meanwhile, TMF can effectively improve drug stability in plasma and reduce systemic tenofovir(TFV) exposure, and make long-term treatment safer. Previous studies have shown that tenofovir disoproxil (TDF), the first generation of TFV, had the effect of lowering blood lipids. While patients who switched to tenofovir alafenamide (TAF), the second generation of TFV, had elevated blood lipids. TMF is a new second generation of TFV and its effect on blood lipids is unclear. Our study aims to figure out the effect of TMF on serum lipid level in the process of antiviral therapy for chronic hepatitis B patients.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Wuhan Union hosipital
Wuhan, Hubei, China
Start Date
January 1, 2022
Primary Completion Date
June 30, 2023
Completion Date
June 30, 2023
Last Updated
June 1, 2022
150
ESTIMATED participants
oral Tenofovir Amibufenamide 25mg each day
DRUG
lipid lowering drugs (e.g. Atorvastatin and amlodipine.)
DRUG
Lead Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NCT04166266
NCT06550622
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