Clinical trial NCT05398393: An Experimental Study on the Effect of Tenofovir Amibufenamide on Blood Lipid During Anti-HBV Treatment
Official title: An Experimental Study on the Effect of Tenofovir Amibufenamide on Blood Lipid During Anti-HBV Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis B, Chronic
Lipid Disorder
Keywords: Tenofovir Amibufenamide
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: Inclusion Criteria:

1. Age 18-70 years old;
2. Chronic hepatitis B patients who meet the CHB diagnostic criteria of "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (Chinese 2019 version)";
3. HBV-DNA can be detected (≥20IU/mL);
4. With or without liver cirrhosis caused by hepatitis B;
5. The treatment plan is TMF antiviral therapy, and no other antiviral drugs are used for at least 1 year before;
6. The clinical data are relatively complete, and the follow-up time reaches 24 weeks (6 months).

Exclusion Criteria:

1. Patients with primary liver cancer or liver metastases;
2. Combined with hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus and human immunodeficiency virus infection;
3. Combined with alcoholic liver disease, drug-induced liver disease, autoimmune liver disease and liver disease caused by other factors;
4. History of treatment of dysglycemia and dyslipidemia;
5. Patients with lactose intolerance;
6. Pregnant women and lactating women;
7. Patients with other serious systemic diseases.

Primary outcomes:
measure: change from baseline HBV-DNA at 1/3/6/12month
timeFrame: baseline, follow up of 1,3,6,12month
measure: change from baseline level of blood lipid at 1/3/6/12month
timeFrame: baseline, follow up of 1,3,6,12month
Secondary outcomes:
measure: change from baseline serum calcium at 6/12month
timeFrame: baseline, follow up of 6,12month
measure: change from baseline serum phosphorus at 6/12month
timeFrame: baseline, follow up of 6,12month
Other outcomes:
measure: change from baseline liver stiffness measurement at 6/12month
timeFrame: baseline, follow up of 6,12month
measure: ultrasonography
timeFrame: baseline, follow up of 6,12month
Locations:
city: Wuhan
country: China
facility: Wuhan Union hosipital
state: Hubei
Study officials:
affiliation: Affiliated to Tongji Medical College, Huazhong University of Science and Technology
name: Wuhan Union hosipital
role: PRINCIPAL_INVESTIGATOR
References:
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