Hepatitis B, ChronicNCT05398393

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

A study testing oral Tenofovir Amibufenamide 25mg each day and lipid lowering drugs (e.g. Atorvastatin and amlodipine.) in people with Hepatitis B, Chronic and Lipid Disorder, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Hepatitis B, Chronic, Lipid Disorder
What is being tested?: oral Tenofovir Amibufenamide 25mg each day and lipid lowering drugs (e.g. Atorvastatin and amlodipine.)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteChina
Study dates: 1 Jan 2022to 30 Jun 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Wuhan Union hosipital
Wuhan, Hubei, 430022

Other trials in China

About this study

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.

Read the 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.

Conditions: Hepatitis B, Chronic, Lipid Disorder
Being tested: oral Tenofovir Amibufenamide 25mg each day, lipid lowering drugs (e.g. Atorvastatin and amlodipine.)
Keywords: Tenofovir Amibufenamide
Medical subject headings: Hepatitis B, Chronic, Lipid Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

oral Tenofovir Amibufenamide 25mg each dayDrug
patients in three groups respectively take one tablet of Tenofovir Amibufenamide(25mg) every day
lipid lowering drugs (e.g. Atorvastatin and amlodipine.)Drug
lipid lowering drugs, , patients in group B1 continue take lipid lowering drugs

Study groups in NCT05398393
Study group	Role	What they receive
group A	Other	normal blood lipid level at baseline Receives: Drug: oral Tenofovir Amibufenamide 25mg each day
group B1	Other	baseline blood lipid is elevated and treat with lipid-lowering drugs Receives: Drug: oral Tenofovir Amibufenamide 25mg each day; Drug: lipid lowering drugs (e.g. Atorvastatin and amlodipine.)
group B2	Other	baseline blood lipid is elevated and without lipid-lowering drugs treatment Receives: Drug: oral Tenofovir Amibufenamide 25mg each day

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202230 Jun 2023

First posted1 Jun 2022
Study start1 Jan 2022
Primary completion30 Jun 2023 (estimated)
Study completion30 Jun 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05398393
Sponsor's protocol ID: UHCT21612
Status last verified: May 2022
First submitted: 10 Mar 2022
Last updated: 1 Jun 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD will be shared including study protocol, statistical analysis, informed consent plan, clinical study report and analytic code

Publications

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.
PubMed 33211179
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.
PubMed 32310899
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.
PubMed 34044856
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.
PubMed 32980447

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

All Hepatitis B, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Experimental Study on the Effect of Tenofovir Amibufenamide on Blood Lipid During Anti-HBV Treatment
ClinicalTrials.gov ID: NCT05398393
Acronym / sponsor ID: UHCT21612
Conditions: Hepatitis B, Chronic, Lipid Disorder
Keywords: Tenofovir Amibufenamide
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 150 participants (estimated)
Lead sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
Study start: 1 Jan 2022 (actual)
Primary completion: 30 Jun 2023 (estimated)
Study completion: 30 Jun 2023 (estimated)
First posted: 1 Jun 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
group A	Other	Drug: oral Tenofovir Amibufenamide 25mg each daynormal blood lipid level at baseline
group B1	Other	Drug: oral Tenofovir Amibufenamide 25mg each day, Drug: lipid lowering drugs (e.g. Atorvastatin and amlodipine.)baseline blood lipid is elevated and treat with lipid-lowering drugs
group B2	Other	Drug: oral Tenofovir Amibufenamide 25mg each daybaseline blood lipid is elevated and without lipid-lowering drugs treatment

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
oral Tenofovir Amibufenamide 25mg each daypatients in three groups respectively take one tablet of Tenofovir Amibufenamide(25mg) every day	Drug	group A, group B1, group B2
lipid lowering drugs (e.g. Atorvastatin and amlodipine.)lipid lowering drugs, , patients in group B1 continue take lipid lowering drugs	Drug	group B1

Primary outcome

change from baseline HBV-DNA at 1/3/6/12month
Time frame: baseline, follow up of 1,3,6,12month
test virological response rate
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

2 secondary outcomes

change from baseline serum calcium at 6/12month
Time frame: baseline, follow up of 6,12month
change from baseline serum phosphorus at 6/12month
Time frame: baseline, follow up of 6,12month

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
Results publication: PubMed 33211179Suzuki 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 publication: PubMed 32310899Lacey 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 publication: PubMed 34044856Ikeda 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 publication: PubMed 32980447Li 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.
Individual participant dataSharing planned: Yes. IPD will be shared including study protocol, statistical analysis, informed consent plan, clinical study report and analytic code

Related trials for Hepatitis B, Chronic

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
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Active, not recruitingPhase 2
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Active, not recruitingPhase 2
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Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wuhan Union hosipital principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change from baseline HBV-DNA at 1/3/6/12month (time frame: baseline, follow up of 1,3,6,12month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05398393, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.