Efficacy and Safety of TMF in the Treatment of CHB Patients With Low-level Viraemia

Sponsor

The Second Affiliated Hospital of Chongqing Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05755776

Collaborator

Jiangsu Hansoh Pharmaceutical Co., Ltd. (Industry)

204

Enrollment

Locations

21.1

Anticipated Duration (Months)

13.6

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this observational study is to explore the efficacy and safety of Tenofovir Amibufenamide (TMF) in Entecavir (ETV) treated chronic hepatitis B patients with low-level viraemia. The main question it aims to answer is:

The efficacy and safety of TMF in chronic hepatitis B patients with low-level viraemia.
What is the appropriate treatment for ETV treated chronic hepatitis B patients with low-level viraemia.

Participants will choose to maintain their original regimen (ETV) or switch to TMF After being fully informed of the benefits and risks of treatment.

Researchers will compare ETV and TMF to see if there is a difference in the efficacy of the two drugs in chronic hepatitis B patients with low-level viraemia.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis B	Drug: TMF

Study Design

Study Type:

Observational

Anticipated Enrollment :

204 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Prospective, Observational, Parallel Control, Multicenter Study to Evaluate the Efficacy and Safety of Tenofovir Amibufenamide in the Treatment of Chronic Hepatitis B Patients With Low-level Viraemia (Power Study)

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
ETV group Participants in this group will continue ETV daily until the end of the study.
TMF group Participants in this group will switch to TMF 25 mg, daily until the end of the study.	Drug: TMF switch ETV to TMF Other Names: Heng Mu

Arm

Intervention/Treatment

ETV group

Participants in this group will continue ETV daily until the end of the study.

TMF group

Participants in this group will switch to TMF 25 mg, daily until the end of the study.

Drug: TMF

switch ETV to TMF

Other Names:

Heng Mu

Outcome Measures

Primary Outcome Measures

The proportions of undetectable HBV DNA in patients treated with ETV and TMF at week 48. [48 weeks]
Undetectable HBV DNA is defined as below 20 IU/mL.

Secondary Outcome Measures

The proportions of undetectable HBV DNA in patients treated with ETV and TMF at week 24. [24 weeks]
Undetectable HBV DNA is defined as below 20 IU/mL.
The proportions of ALT normalization in patients treated with ETV and TMF at week 24 and 48. [24 weeks and 48 weeks]
There are two criteria for ALT normalization. Criteria1: below 40 U/L. Criteria2: Males: ALT<30U/L, female: ALT<19U/L.
Comparing pgRNA levels from baseline at week 24 and 48. [24 weeks and 48 weeks]
Comparing HBcrAg levels from baseline at week 24 and 48. [24 weeks and 48 weeks]
The proportions of undetectable pgRNA in patients treated with ETV and TMF at week 24 and 48. [24 weeks and 48 weeks]
Undetectable pgRNA is defined as below 100 pg/mL.
The proportions of undetectable HBcrAg in patients treated with ETV and TMF at week 24 and 48. [24 weeks and 48 weeks]
Comparing degree of liver fibrosis from baseline at week 24 and 48. [24 weeks and 48 weeks]
Evaluation of liver fibrosis including Fibroscan, APRI and FIB-4.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Must be able to understand and sign a written informed consent, which must be obtained prior to screening.
Male and non-pregnant, non-lactating female subjects who have reached the age of 18-65 years (based on the date of signed informed consent). Female subjects of childbearing age with a negative serum pregnancy test.
Documented signs of chronic HBV infection (e.g., HBsAg positive for more than 6 months.
Subjects treated with ETV for 1 to 3 years will be able to be enrolled in the study.
Subjects with 20 ≤ HBV-DNA < 2000 IU/mL at screening (including intermittent and continuous low-level viraeima).
Must be willing and able to comply with all study requirements.

Exclusion Criteria:

Female patients who are pregnant or breastfeeding or who plan to become pregnant during the study period.
Men and women of childbearing potential who are unwilling to use an "effective" method of contraception as defined in the protocol during the study period.
Co-infection with HCV, HIV, or HDV; or co-infection with autologous liver, metabolism-related fatty liver, or drug-induced liver injury.
Diagnosis of hepatocellular carcinoma by imaging (with evidence of hepatocellular carcinoma)
Patients who have received a solid organ or bone marrow transplant
History of malignancy within 5 years prior to screening, except for specific tumors cured by surgical resection (basal cell dermal skin cancer, etc.); patients evaluated for probable malignancy were ineligible.
Currently receiving treatment with immunomodulators (e.g., corticosteroids), investigational drugs, nephrotoxic drugs, or drugs capable of regulating renal excretion. Drugs that modulate renal excretion.
Renal, cardiovascular, pulmonary, or neurological disease that is considered severe by the investigator.
Severe bone disease (e.g., osteochondrosis, chronic osteomyelitis, osteogenesis imperfecta, chondromalacia) or multiple fractures.
Subjects receiving a contraindicated combination drug (subjects receiving a contraindicated drug require a minimum 30-day washout period) and known hypersensitivity reactions to study drugs, metabolites or formulation excipients.
Current alcohol or drug abuse that, in the investigator's judgment, may interfere with the subject's compliance with study requirements.
Any other clinical condition that, in the opinion of the investigator, would render the subject unsuitable for the study or unable to comply with the dosing requirements medical condition or prior treatment.
Prior or existing clinical liver failure (Child-Pugh score ≥ grade B).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing	China	400010
2	Chongqing University Three Gorges Central Hospital	Chongqing		China	400010
3	Affiliated Hospital of Guangxi Medical University	Guangxi		China
4	Guizhou Provincial People's Hospital	Guiyang		China
5	Hepatobiliary disease of Jilin Province	Jilin		China
6	The First People's Hospital of Yunnan Province	Kunming		China
7	the Second People's Hospital of Yunnan Province	Kunming		China
8	Nanjing Second Hospital	Nanjing		China
9	The Second Hospital of Ningbo	Ningbo		China
10	Shanghai East Hospital	Shanghai		China
11	Shuguang Hospital, Shanghai, China.	Shanghai		China
12	The Sixth People's Hospital of Shenyang	Shenyang		China
13	Shijiazhuang Fifth Hospital	Shijiazhuang		China
14	The First People's Hospital of Taicang	Taicang		China
15	The Fourth People's Hospital of Zibo	Zibo		China