An Experimental Study on the Effect of Tenofovir Amibufenamide on Blood Lipid During Anti-HBV Treatment

Sponsor

Wuhan Union Hospital, China (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05398393

Collaborator

(none)

150

Enrollment

Location

Arms

17.9

Anticipated Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B, Chronic Lipid Disorder	Drug: oral Tenofovir Amibufenamide 25mg each day Drug: lipid lowering drugs (e.g. Atorvastatin and amlodipine.)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Experimental Study on the Effect of Tenofovir Amibufenamide on Blood Lipid During Anti-HBV Treatment

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: group A normal blood lipid level at baseline	Drug: oral Tenofovir Amibufenamide 25mg each day patients in three groups respectively take one tablet of Tenofovir Amibufenamide(25mg) every day
Other: group B1 baseline blood lipid is elevated and treat with lipid-lowering drugs	Drug: oral Tenofovir Amibufenamide 25mg each day patients in three groups respectively take one tablet of Tenofovir Amibufenamide(25mg) every day Drug: lipid lowering drugs (e.g. Atorvastatin and amlodipine.) lipid lowering drugs, , patients in group B1 continue take lipid lowering drugs
Other: group B2 baseline blood lipid is elevated and without lipid-lowering drugs treatment	Drug: oral Tenofovir Amibufenamide 25mg each day patients in three groups respectively take one tablet of Tenofovir Amibufenamide(25mg) every day

Arm

Intervention/Treatment

Other: group A

normal blood lipid level at baseline

Drug: oral Tenofovir Amibufenamide 25mg each day

patients in three groups respectively take one tablet of Tenofovir Amibufenamide(25mg) every day

Other: group B1

baseline blood lipid is elevated and treat with lipid-lowering drugs

Drug: oral Tenofovir Amibufenamide 25mg each day

patients in three groups respectively take one tablet of Tenofovir Amibufenamide(25mg) every day

Drug: lipid lowering drugs (e.g. Atorvastatin and amlodipine.)

lipid lowering drugs, , patients in group B1 continue take lipid lowering drugs

Other: group B2

baseline blood lipid is elevated and without lipid-lowering drugs treatment

Drug: oral Tenofovir Amibufenamide 25mg each day

patients in three groups respectively take one tablet of Tenofovir Amibufenamide(25mg) every day

Outcome Measures

Primary Outcome Measures

change from baseline HBV-DNA at 1/3/6/12month [baseline, follow up of 1,3,6,12month]
test virological response rate
change from baseline level of blood lipid at 1/3/6/12month [baseline, follow up of 1,3,6,12month]
test blood lipid level

Secondary Outcome Measures

change from baseline serum calcium at 6/12month [baseline, follow up of 6,12month]
test blood serum calcium
change from baseline serum phosphorus at 6/12month [baseline, follow up of 6,12month]
test blood serum phosphorus

Other Outcome Measures

change from baseline liver stiffness measurement at 6/12month [baseline, follow up of 6,12month]
test liver stiffness measurement and controlled attenuation parament through transient elastography(FibroTouch)
ultrasonography [baseline, follow up of 6,12month]
liver ultrasonography

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.