HBV InfectionPromoteNCT05797714
The Effectiveness and Safety of TMF in the Treatment of Chronic Hepatitis B Patients With Normal ALT.
A study testing Tenofovir Amibufenamide（TMF） in people with HBV Infection and Chronic Hepatitis b, run by Ruijin Hospital at 12 sites in China.
Trial summary
This is a multicenter, randomized, open, blank controlled trial ，in order to evaluate the effectiveness and safety of Amibufenamide（TMF） in the treatment of chronic hepatitis B virus infection patients with normal ALT . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HBV Infection, Chronic Hepatitis b
- What is being tested?
- Tenofovir Amibufenamide（TMF）
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 12 sitesChina
- Study dates
- 8 Jun 2022to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study screening.
- Male and non-pregnant, non-lactating females, from 18 up to 65 years of age (based on the date of the screening visit). A negative serum pregnancy test at screening is required for female subjects of childbearing potential.
- Documented evidence of chronic HBV infection (e.g. HBsAg positive for more than 6 months).
- Normal alanine aminotransferase: serum HBV DNA >20 IU/mL and serum ALT level ≤ULN (40 IU/L) during screening.
- Treatment-naive subjects will be eligible for enrollment.
- Must be willing and able to comply with all study requirements.
Who cannot join
- Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study.
- Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study.
- Co-infection with HCV virus, HIV, HEV or HDV or combined with autoimmune liver disease, metabolism-related fatty liver disease, drug-induced liver injury;
- Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging).
- Any history of, or current evidence of, clinical hepatic decompensation (e.g. ascites encephalopathy or variceal hemorrhage) or liver stiffness over 9kpa measured by TE.
- Abnormal hematological and biochemical parameters, including:
Show all 14Show fewer
- Hemoglobin < 10 g/dl Absolute neutrophil count < 0.75 × 10^9/L Platelets ≤ 50 × 10^9/L AST > 10 × ULN Total Bilirubin > 2.5 × ULN Albumin < 3.0 g/dL INR > 1.5 × ULN (unless stable on anticoagulant regimen) eGFR<50mL/min
- Received solid organ or bone marrow transplant.
- Malignancy within the 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc).
- Currently receiving therapy with immunomodulators (e.g. corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion.
- Complicated with uncontrollable cardiovascular and cerebrovascular diseases.
- Subjects on prohibited concomitant medications. Subjects on prohibited medications, otherwise eligible, will need a wash out period of at least 30 days,Known hypersensitivity to study drugs, metabolites, or formulation excipients.
- Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance.
- Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Beijing You'An Hospital, Capital Medical University
Beijing
The Second Xiangya Hospital, Central South University
Changsha, Hunan
People's Hospital of Dongyang City
Dongyang
Fuyang Second People's Hospital
Fuyang
The First People's Hospital of Xiaoshan District, Hangzhou, Zhejiang Province
Hangzhou
LiShui People's Hospital of Zhejiang Province
Lishui
The First Affiliated Hospital of Nanchang University
Nanchang
Jiangsu Province Hospital
Nanjin
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Shanghai
Shanghai East Hospital
Shanghai
The Fifth People's Hospital of Suzhou
Suzhou
The Fifth People's Hospital of Wuxi
Wuxi
About this study
Official title: A Prospective, Randomized, Blank Control, Multicenter Study to Evaluate the Efficacy and Safety of Alanine Aminotransferase（TMF）in the Treatment of Chronic Hepatitis B Patients With Normal Alanine Aminotransferase.
This is a multicenter, randomized, open, blank controlled trial ，in order to evaluate the effectiveness and safety of Amibufenamide（TMF） in the treatment of chronic hepatitis B virus infection patients with normal ALT .
Read the detailed description
Although the indications for antiviral therapy for patients with chronic hepatitis B have been gradually expanded in different guidelines, antiviral treatment efficacy remains unclear among patients with alanine aminotransferase (ALT) < 1 upper limits of normal (ULN). This study aimed to evaluate the the effectiveness and safety of TMF for these patients.
Tenofovir amibufenamide (TMF; codename: HS-10234), another formulation of tenofovir, shared the same ProTide technology as tenofovir alafenamide, which can provide more efficient intracellular delivery than TDF.
- Conditions
- HBV Infection, Chronic Hepatitis b
- Being tested
- Tenofovir Amibufenamide（TMF）
- Keywords
- Normal Alanine Aminotransferase, Treatment, Effectiveness, Safety
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Amibufenamide（TMF）Drug
Also called HengMu
TMF, 25mg QD, from baseline to 240 weeks
| Study group | Role | What they receive |
|---|---|---|
| TMF treatment group | Experimental | TMF 25mg QD, from baseline to 240 weeks Receives: Drug: Tenofovir Amibufenamide（TMF） |
| Blank control group | No intervention | No antiviral therapy is given. If ALT>2 ULN (40 IU/L) for HBeAg-positive patients or > ULN for HBeAg-negative patients during the study period, blank control group can be switched to TMF treatment once a day, 25mg/ time orally until the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA < 20 IU/mL
The primary efficacy endpoint was the proportion of patients with HBV DNA < 20 IU/mL at week 48
Measured: Week 48
Secondary outcomes (14)
Evaluation the change from Baseline in HBV DNA
Change from baseline in HBV DNA
Measured: Week 48，Week 96，Week 144，week 240
Evaluation the proportion of Patients Achieving Hepatitis B Surface Antigen (HBsAg) Loss
Proportion of patients achieving Hepatitis B surface antigen (HBsAg) loss
Measured: Week 48，Week 96，Week 144，Week 240
Evaluation the proportion of Patients Achieving HBsAg Seroconversion
Proportion of patients achieving HBsAg seroconversion
Measured: Week 48，Week 96, Week 144, Week 240
Evaluation the proportion of Patients Achieving HBeAg Seroconversion
Proportion of patients achieving HBeAg seroconversion
Measured: Week 48，Week 96，Week 144, Week 240
Evaluation the proportion of Patients Achieving HBeAg Loss
Proportion of patients Achieving HBeAg Loss
Measured: Week 48，Week 96，Week 144 ，Week 240
Evaluation the change from Baseline in HBsAg
Change from baseline in HBsAg
Measured: Week 48，Week 96，Week 144，Week 240
Evaluation the percentage of Participants with resistance
Percentage of participants with resistance
Measured: Week 48，Week 96，Week 144，Week 240
Evaluation the change from Baseline in liver fibrosis
Change from baseline in liver fibrosis
Measured: Week 48，Week 96，Week 144，Week 240
Evaluation the proportion of Patients with get hepatitis acute attack（ALT >5 ULN (40 IU/L)）
Proportion of patients with get hepatitis acute attack（ALT >5 ULN (40 IU/L)）
Measured: Week 48，Week 96，Week 144，Week 240
Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA < 20 IU/mL
Measured: Week 96，Week 144，Week 240
Evaluation the change from Baseline in Bone biomarker（β-CTX and P1NP）
Measured: Week 48，Week 96，Week 144，Week 240
Evaluation the change from Baseline in sCR
Measured: Week 48，Week 96，Week 144，Week 240
AE ,SAE
Measured: Week 48，Week 96，Week 144，Week 240
The proportion of subjects with liver-related events
Liver decompensation, acute-on-chronic liver failure, hepatocellular carcinoma, liver transplantation, all-cause mortality
Measured: Week 48，96，144，192，240
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start8 Jun 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HBV InfectionStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The subjects were randomly divided into two groups. One group received TMF treatment for 48 weeks. Aonther group received no antiviral therapy and served as a blank control.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797714
- Sponsor's protocol ID
- Promote
- Acronym
- Promote
- Status last verified
- Nov 2025
- First submitted
- 22 Mar 2023
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu Z, Jin Q, Zhang Y, Gong G, Wu G, Yao L, Wen X, Gao Z, Huang Y, Yang D, Chen E, Mao Q, Lin S, Shang J, Gong H, Zhong L, Yin H, Wang F, Hu P, Xiao L, Li C, Wu Q, Sun C, Niu J, Hou J; TMF Study Group. Randomised clinical trial: 48 weeks of treatment with tenofovir amibufenamide versus tenofovir disoproxil fumarate for patients with chronic hepatitis B. Aliment Pharmacol Ther. 2021 Nov;54(9):1134-1149. doi: 10.1111/apt.16611. Epub 2021 Sep 29.
PubMed 34587302Gui H, Shen Y, Tan L, Hu P, Qian F, Wu X, Qiu Y, Zheng S, Lv J, Shi Y, Li J, Jiang Y, Hu Z, Nie F, Huo Y, Qu L, Xie Q. Interim Analysis of 48-week Tenofovir Amibufenamide Treatment in Chronic Hepatitis B Patients with Normal Alanine Aminotransferase Levels: The PROMOTE Study. J Clin Transl Hepatol. 2025 Jul 28;13(7):568-577. doi: 10.14218/JCTH.2025.00162. Epub 2025 Jun 30.
PubMed 40937079
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Blank Control, Multicenter Study to Evaluate the Efficacy and Safety of Alanine Aminotransferase（TMF）in the Treatment of Chronic Hepatitis B Patients With Normal Alanine Aminotransferase.
- ClinicalTrials.gov ID
- NCT05797714
- Acronym / sponsor ID
- Promote / Promote
- Conditions
- HBV Infection, Chronic Hepatitis b
- Keywords
- Normal Alanine Aminotransferase, Treatment, Effectiveness, Safety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 4 Apr 2023 (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.
This is a multicenter, randomized, open, blank controlled trial ，in order to evaluate the effectiveness and safety of Amibufenamide（TMF） in the treatment of chronic hepatitis B virus infection patients with normal ALT .
Detailed description
Although the indications for antiviral therapy for patients with chronic hepatitis B have been gradually expanded in different guidelines, antiviral treatment efficacy remains unclear among patients with alanine aminotransferase (ALT) < 1 upper limits of normal (ULN). This study aimed to evaluate the the effectiveness and safety of TMF for these patients.
Tenofovir amibufenamide (TMF; codename: HS-10234), another formulation of tenofovir, shared the same ProTide technology as tenofovir alafenamide, which can provide more efficient intracellular delivery than TDF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The subjects were randomly divided into two groups. One group received TMF treatment for 48 weeks. Aonther group received no antiviral therapy and served as a blank control.
| Arm | Type | Receives |
|---|---|---|
| TMF treatment group | Experimental | Drug: Tenofovir Amibufenamide（TMF）TMF 25mg QD, from baseline to 240 weeks |
| Blank control group | No intervention | –No antiviral therapy is given. If ALT>2 ULN (40 IU/L) for HBeAg-positive patients or > ULN for HBeAg-negative patients during the study period, blank control group can be switched to TMF treatment once a day, 25mg/ time orally until the end of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study screening.
- Male and non-pregnant, non-lactating females, from 18 up to 65 years of age (based on the date of the screening visit). A negative serum pregnancy test at screening is required for female subjects of childbearing potential.
- Documented evidence of chronic HBV infection (e.g. HBsAg positive for more than 6 months).
- Normal alanine aminotransferase: serum HBV DNA >20 IU/mL and serum ALT level ≤ULN (40 IU/L) during screening.
- Treatment-naive subjects will be eligible for enrollment.
Key exclusion criteria (14 listed)
- Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study.
- Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study.
- Co-infection with HCV virus, HIV, HEV or HDV or combined with autoimmune liver disease, metabolism-related fatty liver disease, drug-induced liver injury;
- Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging).
- Any history of, or current evidence of, clinical hepatic decompensation (e.g. ascites encephalopathy or variceal hemorrhage) or liver stiffness over 9kpa measured by TE.
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 |
|---|---|---|
| Tenofovir Amibufenamide（TMF）Also: HengMuTMF, 25mg QD, from baseline to 240 weeks | Drug | TMF treatment group |
Primary outcome
Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA < 20 IU/mL
Time frame: Week 48
The primary efficacy endpoint was the proportion of patients with HBV DNA < 20 IU/mL at week 48
14 secondary outcomes
Evaluation the change from Baseline in HBV DNA
Time frame: Week 48，Week 96，Week 144，week 240
Evaluation the proportion of Patients Achieving Hepatitis B Surface Antigen (HBsAg) Loss
Time frame: Week 48，Week 96，Week 144，Week 240
Evaluation the proportion of Patients Achieving HBsAg Seroconversion
Time frame: Week 48，Week 96, Week 144, Week 240
Evaluation the proportion of Patients Achieving HBeAg Seroconversion
Time frame: Week 48，Week 96，Week 144, Week 240
Evaluation the proportion of Patients Achieving HBeAg Loss
Time frame: Week 48，Week 96，Week 144 ，Week 240
Evaluation the change from Baseline in HBsAg
Time frame: Week 48，Week 96，Week 144，Week 240
Evaluation the percentage of Participants with resistance
Time frame: Week 48，Week 96，Week 144，Week 240
Evaluation the change from Baseline in liver fibrosis
Time frame: Week 48，Week 96，Week 144，Week 240
Evaluation the proportion of Patients with get hepatitis acute attack（ALT >5 ULN (40 IU/L)）
Time frame: Week 48，Week 96，Week 144，Week 240
Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA < 20 IU/mL
Time frame: Week 96，Week 144，Week 240
Evaluation the change from Baseline in Bone biomarker（β-CTX and P1NP）
Time frame: Week 48，Week 96，Week 144，Week 240
Evaluation the change from Baseline in sCR
Time frame: Week 48，Week 96，Week 144，Week 240
AE ,SAE
Time frame: Week 48，Week 96，Week 144，Week 240
The proportion of subjects with liver-related events
Time frame: Week 48，96，144，192，240
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Background: PubMed 34587302Liu Z, Jin Q, Zhang Y, Gong G, Wu G, Yao L, Wen X, Gao Z, Huang Y, Yang D, Chen E, Mao Q, Lin S, Shang J, Gong H, Zhong L, Yin H, Wang F, Hu P, Xiao L, Li C, Wu Q, Sun C, Niu J, Hou J; TMF Study Group. Randomised clinical trial: 48 weeks of treatment with tenofovir amibufenamide versus tenofovir disoproxil fumarate for patients with chronic hepatitis B. Aliment Pharmacol Ther. 2021 Nov;54(9):1134-1149. doi: 10.1111/apt.16611. Epub 2021 Sep 29.
- Results publication: PubMed 40937079Gui H, Shen Y, Tan L, Hu P, Qian F, Wu X, Qiu Y, Zheng S, Lv J, Shi Y, Li J, Jiang Y, Hu Z, Nie F, Huo Y, Qu L, Xie Q. Interim Analysis of 48-week Tenofovir Amibufenamide Treatment in Chronic Hepatitis B Patients with Normal Alanine Aminotransferase Levels: The PROMOTE Study. J Clin Transl Hepatol. 2025 Jul 28;13(7):568-577. doi: 10.14218/JCTH.2025.00162. Epub 2025 Jun 30.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tenofovir Amibufenamide（TMF） in people with HBV Infection and Chronic Hepatitis b, run by Ruijin Hospital at 12 sites in China.
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 14 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: under way, not looking for participants, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA < 20 IU/mL (time frame: Week 48). 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 NCT05797714, which also lists 2 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 17 Nov 2025.