search
Back to results

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

Primary Purpose

Hepatitis B, Chronic, Lipid Disorder

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
oral Tenofovir Amibufenamide 25mg each day
lipid lowering drugs (e.g. Atorvastatin and amlodipine.)
Sponsored by
Wuhan Union Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring Tenofovir Amibufenamide

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wuhan Union hosipital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

group A

group B1

group B2

Arm Description

normal blood lipid level at baseline

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

change from baseline serum calcium at 6/12month
test blood serum calcium
change from baseline serum phosphorus at 6/12month
test blood serum phosphorus

Full Information

First Posted
March 10, 2022
Last Updated
May 25, 2022
Sponsor
Wuhan Union Hospital, China
search

1. Study Identification

Unique Protocol Identification Number
NCT05398393
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan Union Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic, Lipid Disorder
Keywords
Tenofovir Amibufenamide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Other
Arm Description
normal blood lipid level at baseline
Arm Title
group B1
Arm Type
Other
Arm Description
baseline blood lipid is elevated and treat with lipid-lowering drugs
Arm Title
group B2
Arm Type
Other
Arm Description
baseline blood lipid is elevated and without lipid-lowering drugs treatment
Intervention Type
Drug
Intervention Name(s)
oral Tenofovir Amibufenamide 25mg each day
Intervention Description
patients in three groups respectively take one tablet of Tenofovir Amibufenamide(25mg) every day
Intervention Type
Drug
Intervention Name(s)
lipid lowering drugs (e.g. Atorvastatin and amlodipine.)
Intervention Description
lipid lowering drugs, , patients in group B1 continue take lipid lowering drugs
Primary Outcome Measure Information:
Title
change from baseline HBV-DNA at 1/3/6/12month
Description
test virological response rate
Time Frame
baseline, follow up of 1,3,6,12month
Title
change from baseline level of blood lipid at 1/3/6/12month
Description
test blood lipid level
Time Frame
baseline, follow up of 1,3,6,12month
Secondary Outcome Measure Information:
Title
change from baseline serum calcium at 6/12month
Description
test blood serum calcium
Time Frame
baseline, follow up of 6,12month
Title
change from baseline serum phosphorus at 6/12month
Description
test blood serum phosphorus
Time Frame
baseline, follow up of 6,12month
Other Pre-specified Outcome Measures:
Title
change from baseline liver stiffness measurement at 6/12month
Description
test liver stiffness measurement and controlled attenuation parament through transient elastography(FibroTouch)
Time Frame
baseline, follow up of 6,12month
Title
ultrasonography
Description
liver ultrasonography
Time Frame
baseline, follow up of 6,12month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wuhan Union hosipital
Organizational Affiliation
Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wuhan Union hosipital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.whuh.com/
Citations:
PubMed Identifier
33211179
Citation
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.
Results Reference
result
PubMed Identifier
32310899
Citation
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.
Results Reference
result
PubMed Identifier
34044856
Citation
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.
Results Reference
result
PubMed Identifier
32980447
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs