The Effectiveness and Safety of TMF in the Treatment of Chronic Hepatitis B Patients With Normal ALT.

NCT05797714 | Active Not Recruiting

• 1 other identifier: Promote
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 12

Brief 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 .

Conditions

HBV Infection; Chronic Hepatitis b

Keywords

Normal Alanine Aminotransferase; Treatment; Effectiveness; Safety

Outcome Measures

Primary Outcomes (1)

• 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

  Week 48

Secondary Outcomes (14)

• Evaluation the change from Baseline in HBV DNA

  Week 48，Week 96，Week 144，week 240

• Evaluation the proportion of Patients Achieving Hepatitis B Surface Antigen (HBsAg) Loss

  Week 48，Week 96，Week 144，Week 240

• Evaluation the proportion of Patients Achieving HBsAg Seroconversion

  Week 48，Week 96, Week 144, Week 240

• Evaluation the proportion of Patients Achieving HBeAg Seroconversion

  Week 48，Week 96，Week 144, Week 240

• Evaluation the proportion of Patients Achieving HBeAg Loss

  Week 48，Week 96，Week 144 ，Week 240

Study Arms (2)

TMF treatment group

EXPERIMENTAL

TMF 25mg QD, from baseline to 240 weeks

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.

Interventions

Tenofovir Amibufenamide（TMF） DRUG

TMF, 25mg QD, from baseline to 240 weeks

Also known as: HengMu

TMF treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Jiangsu Hansoh Pharmaceutical Co., Ltd.: collaborator

Study Sites (12)

The Second Xiangya Hospital, Central South University

Changsha, Hunan, China

Location

Beijing You'An Hospital, Capital Medical University

Beijing, China

Location

People's Hospital of Dongyang City

Dongyang, China

Location

Fuyang Second People's Hospital

Fuyang, China

Location

The First People's Hospital of Xiaoshan District, Hangzhou, Zhejiang Province

Hangzhou, China

Location

LiShui People's Hospital of Zhejiang Province

Lishui, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, China

Location

Jiangsu Province Hospital

Nanjin, China

Location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

Shanghai, China

Location

Shanghai East Hospital

Shanghai, China

Location

The Fifth People's Hospital of Suzhou

Suzhou, China

Location

The Fifth People's Hospital of Wuxi

Wuxi, China

Location

Related Publications (2)

• 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.

  PMID: 34587302 BACKGROUND

• Gui 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.

  PMID: 40937079 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 4, 2023
• Study Start: June 8, 2022
• Primary Completion: April 30, 2024
• Study Completion (Estimated): April 30, 2028
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)