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

Primary Purpose

HBV Infection, Chronic Hepatitis b

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tenofovir Amibufenamide(TMF)
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HBV Infection focused on measuring Normal Alanine Aminotransferase, Treatment, Effectiveness, Safety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Beijing You'An Hospital, Capital Medical UniversityRecruiting
  • People's Hospital of Dongyang CityRecruiting
  • Fuyang Second People's HospitalRecruiting
  • The First People's Hospital of Xiaoshan District, Hangzhou, Zhejiang ProvinceRecruiting
  • LiShui People's Hospital of Zhejiang ProvinceRecruiting
  • The First Affiliated Hospital of Nanchang UniversityRecruiting
  • Jiangsu Province HospitalRecruiting
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.Recruiting
  • Shanghai East HospitalRecruiting
  • Xiangya Hospital Central South University
  • The Fifth People's Hospital of SuzhouRecruiting
  • The Fifth People's Hospital of WuxiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TMF treatment group

Blank control group

Arm Description

TMF 25mg QD, from baseline to 48 weeks

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluation the change from Baseline in HBV DNA
Change from baseline in HBV DNA
Evaluation the proportion of Patients Achieving Hepatitis B Surface Antigen (HBsAg) Loss
Proportion of patients achieving Hepatitis B surface antigen (HBsAg) loss
Evaluation the proportion of Patients Achieving HBsAg Seroconversion
Proportion of patients achieving HBsAg seroconversion
Evaluation the proportion of Patients Achieving HBeAg Seroconversion
Proportion of patients achieving HBeAg seroconversion
Evaluation the proportion of Patients Achieving HBeAg Loss
Proportion of patients Achieving HBeAg Loss
Evaluation the change from Baseline in HBsAg
Change from baseline in HBsAg
Evaluation the percentage of Participants with resistance
Percentage of participants with resistance
Evaluation the change from Baseline in liver fibrosis
Change from baseline in liver fibrosis
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))

Full Information

First Posted
March 22, 2023
Last Updated
March 22, 2023
Sponsor
Ruijin Hospital
Collaborators
Jiangsu Hansoh Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05797714
Brief Title
The Effectiveness and Safety of TMF in the Treatment of Chronic Hepatitis B Patients With Normal ALT.
Acronym
Promote
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2022 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
April 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ruijin Hospital
Collaborators
Jiangsu Hansoh Pharmaceutical Co., Ltd.

4. Oversight

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

5. Study Description

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 at week 48.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HBV Infection, Chronic Hepatitis b
Keywords
Normal Alanine Aminotransferase, Treatment, Effectiveness, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TMF treatment group
Arm Type
Experimental
Arm Description
TMF 25mg QD, from baseline to 48 weeks
Arm Title
Blank control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tenofovir Amibufenamide(TMF)
Other Intervention Name(s)
HengMu
Intervention Description
TMF, 25mg QD, from baseline to 48 weeks
Primary Outcome Measure Information:
Title
Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA < 20 IU/mL
Description
The primary efficacy endpoint was the proportion of patients with HBV DNA < 20 IU/mL at week 48
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Evaluation the change from Baseline in HBV DNA
Description
Change from baseline in HBV DNA
Time Frame
Week 48
Title
Evaluation the proportion of Patients Achieving Hepatitis B Surface Antigen (HBsAg) Loss
Description
Proportion of patients achieving Hepatitis B surface antigen (HBsAg) loss
Time Frame
Week 48
Title
Evaluation the proportion of Patients Achieving HBsAg Seroconversion
Description
Proportion of patients achieving HBsAg seroconversion
Time Frame
Week 48
Title
Evaluation the proportion of Patients Achieving HBeAg Seroconversion
Description
Proportion of patients achieving HBeAg seroconversion
Time Frame
Week 48
Title
Evaluation the proportion of Patients Achieving HBeAg Loss
Description
Proportion of patients Achieving HBeAg Loss
Time Frame
Week 48
Title
Evaluation the change from Baseline in HBsAg
Description
Change from baseline in HBsAg
Time Frame
Week 48
Title
Evaluation the percentage of Participants with resistance
Description
Percentage of participants with resistance
Time Frame
Week 48
Title
Evaluation the change from Baseline in liver fibrosis
Description
Change from baseline in liver fibrosis
Time Frame
Week 48
Title
Evaluation the proportion of Patients with get hepatitis acute attack(ALT >5 ULN (40 IU/L))
Description
Proportion of patients with get hepatitis acute attack(ALT >5 ULN (40 IU/L))
Time Frame
Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Beijing You'An Hospital, Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sujun Zheng
Phone
15810716239
Email
zhengsujun003@126.com
Facility Name
People's Hospital of Dongyang City
City
Dongyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YunZhen shi
Phone
13566947234
Email
syzwylwmc@163.com
Facility Name
Fuyang Second People's Hospital
City
Fuyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Tan
Phone
13861872462
Email
TANL558@163.COM
Facility Name
The First People's Hospital of Xiaoshan District, Hangzhou, Zhejiang Province
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piao Hu
Phone
18969957010
Email
hupiao2013@163.com
Facility Name
LiShui People's Hospital of Zhejiang Province
City
LiShui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JiaoJian LV
Phone
18957091505
Email
lslvjiaojian@126.com
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoping Wu
Phone
133 3012 2823
Email
Wuxiaoping2823@aliyun.com
Facility Name
Jiangsu Province Hospital
City
Nanjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Li
Phone
13905175333
Email
dr-lijun@vip.sina.com
Facility Name
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qing Xie
Phone
13651804273
Email
xieqinggrjh@163.com
Facility Name
Shanghai East Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lihong Qu
Phone
18916510601
Email
18916510601@163.com
Facility Name
Xiangya Hospital Central South University
City
Sichuan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Fifth People's Hospital of Suzhou
City
Suzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Qian
Phone
13913572662
Email
fengqian70@126.com
Facility Name
The Fifth People's Hospital of Wuxi
City
Wuxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanwang Qiu
Phone
13861872462
Email
qywang839@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34587302
Citation
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.
Results Reference
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Learn more about this trial

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

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