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 .
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
TMF, 25mg QD, from baseline to 240 weeks
The Second Xiangya Hospital, Central South University
Changsha, Hunan, China
Beijing You'An Hospital, Capital Medical University
Beijing, China
People's Hospital of Dongyang City
Dongyang, China
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
Time frame: Week 48
Evaluation the change from Baseline in HBV DNA
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
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
Proportion of patients achieving HBsAg seroconversion
Time frame: Week 48,Week 96, Week 144, Week 240
Evaluation the proportion of Patients Achieving HBeAg Seroconversion
Proportion of patients achieving HBeAg seroconversion
Time frame: Week 48,Week 96,Week 144, Week 240
Evaluation the proportion of Patients Achieving HBeAg Loss
Proportion of patients Achieving HBeAg Loss
Time frame: Week 48,Week 96,Week 144 ,Week 240
Evaluation the change from Baseline in HBsAg
Change from baseline in HBsAg
Time frame: Week 48,Week 96,Week 144,Week 240
Evaluation the percentage of Participants with resistance
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Fuyang Second People's Hospital
Fuyang, China
The First People's Hospital of Xiaoshan District, Hangzhou, Zhejiang Province
Hangzhou, China
LiShui People's Hospital of Zhejiang Province
Lishui, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Jiangsu Province Hospital
Nanjin, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Shanghai, China
Shanghai East Hospital
Shanghai, China
...and 2 more locations
Percentage of participants with resistance
Time frame: Week 48,Week 96,Week 144,Week 240
Evaluation the change from Baseline in liver fibrosis
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))
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
Liver decompensation, acute-on-chronic liver failure, hepatocellular carcinoma, liver transplantation, all-cause mortality
Time frame: Week 48,96,144,192,240