NCT05398393

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

1.5 years

First QC Date

March 10, 2022

Last Update Submit

May 25, 2022

Conditions

Hepatitis B, ChronicLipid Disorder

Keywords

Tenofovir Amibufenamide

Outcome Measures

Primary Outcomes (2)

  • change from baseline HBV-DNA at 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

    test blood lipid level

    baseline, follow up of 1,3,6,12month

Secondary Outcomes (2)

  • change from baseline serum calcium at 6/12month

    baseline, follow up of 6,12month

  • change from baseline serum phosphorus at 6/12month

    baseline, follow up of 6,12month

Other Outcomes (2)

  • change from baseline liver stiffness measurement at 6/12month

    baseline, follow up of 6,12month

  • ultrasonography

    baseline, follow up of 6,12month

Study Arms (3)

group A

OTHER

normal blood lipid level at baseline

Drug: oral Tenofovir Amibufenamide 25mg each day

group B1

OTHER

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

Drug: oral Tenofovir Amibufenamide 25mg each dayDrug: lipid lowering drugs (e.g. Atorvastatin and amlodipine.)

group B2

OTHER

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

Drug: oral Tenofovir Amibufenamide 25mg each day

Interventions

oral Tenofovir Amibufenamide 25mg each dayDRUG

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

group Agroup B1group B2
lipid lowering drugs (e.g. Atorvastatin and amlodipine.)DRUG

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

group B1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Union hosipital

Wuhan, Hubei, 430022, China

Location

Related Publications (4)

  • Suzuki K, Suda G, Yamamoto Y, Furuya K, Baba M, Nakamura A, Miyoshi H, Kimura M, Maehara O, Yamada R, Kitagataya T, Yamamoto K, Shigesawa T, Nakamura A, Ohara M, Kawagishi N, Nakai M, Sho T, Natsuizaka M, Morikawa K, Ogawa K, Ohnishi S, Sakamoto N; NORTE Study Group. Tenofovir-disoproxil-fumarate modulates lipid metabolism via hepatic CD36/PPAR-alpha activation in hepatitis B virus infection. J Gastroenterol. 2021 Feb;56(2):168-180. doi: 10.1007/s00535-020-01750-3. Epub 2020 Nov 19.

    PMID: 33211179RESULT

  • Lacey A, Savinelli S, Barco EA, Macken A, Cotter AG, Sheehan G, Lambert JS, Muldoon E, Feeney E, Mallon PW, Tinago W; UCD ID Cohort Study. Investigating the effect of antiretroviral switch to tenofovir alafenamide on lipid profiles in people living with HIV. AIDS. 2020 Jul 1;34(8):1161-1170. doi: 10.1097/QAD.0000000000002541.

    PMID: 32310899RESULT

  • Ikeda M, Wakabayashi Y, Okamoto K, Yanagimoto S, Okugawa S, Moriya K. Changing trends in lipid profile and biomarkers of renal function and bone metabolism before and after switching from tenofovir disoproxil fumarate to tenofovir alafenamide: a prospective observational study. AIDS Res Ther. 2021 May 27;18(1):30. doi: 10.1186/s12981-021-00354-y.

    PMID: 34044856RESULT

  • Li M, Zhou L, Dorsey HG, Musoff C, Jnr DA, Schoen N, Djan K, Paintsil E. Tenofovir alafenamide does not inhibit mitochondrial function and cholesterol biosynthesis in human T lymphoblastoid cell line. Antiviral Res. 2020 Nov;183:104948. doi: 10.1016/j.antiviral.2020.104948. Epub 2020 Sep 24.

    PMID: 32980447RESULT

MeSH Terms

Conditions

Hepatitis B, ChronicLipid Metabolism Disorders

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Wuhan Union hosipital

    Affiliated to Tongji Medical College, Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor, chief doctor

Study Record Dates

First Submitted

March 10, 2022

First Posted

June 1, 2022

Study Start

January 1, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
the data will be available after June 2023
Access Criteria
academic exchange
More information

Locations

CN(1)