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

May 25, 2022 updated by: Jin Ye, Wuhan Union Hospital, China
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan Union hosipital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline HBV-DNA at 1/3/6/12month
Time Frame: baseline, follow up of 1,3,6,12month
test virological response rate
baseline, follow up of 1,3,6,12month
change from baseline level of blood lipid at 1/3/6/12month
Time Frame: baseline, follow up of 1,3,6,12month
test blood lipid level
baseline, follow up of 1,3,6,12month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline serum calcium at 6/12month
Time Frame: baseline, follow up of 6,12month
test blood serum calcium
baseline, follow up of 6,12month
change from baseline serum phosphorus at 6/12month
Time Frame: baseline, follow up of 6,12month
test blood serum phosphorus
baseline, follow up of 6,12month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline liver stiffness measurement at 6/12month
Time Frame: baseline, follow up of 6,12month
test liver stiffness measurement and controlled attenuation parament through transient elastography(FibroTouch)
baseline, follow up of 6,12month
ultrasonography
Time Frame: baseline, follow up of 6,12month
liver ultrasonography
baseline, follow up of 6,12month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Union Hospital, China

Investigators

  • Principal Investigator: Wuhan Union hosipital, Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

March 10, 2022

First Submitted That Met QC Criteria

May 25, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

June 1, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHCT21612

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

IPD will be shared including study protocol, statistical analysis, informed consent plan, clinical study report and analytic code

IPD Sharing Time Frame

the data will be available after June 2023

IPD Sharing Access Criteria

academic exchange

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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