Chronic Hepatitis b Clinical Trial
— PromoteOfficial 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.
Verified date | March 2024 |
Source | Ruijin Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 .
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | April 15, 2026 |
Est. primary completion date | June 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study screening. 2. 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. 3. Documented evidence of chronic HBV infection (e.g. HBsAg positive for more than 6 months). 4. Normal alanine aminotransferase: serum HBV DNA >20 IU/mL and serum ALT level =ULN (40 IU/L) during screening. 5. Treatment-naive subjects will be eligible for enrollment. 6. Must be willing and able to comply with all study requirements. Exclusion Criteria: 1. Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study. 2. Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study. 3. Co-infection with HCV virus, HIV, HEV or HDV or combined with autoimmune liver disease, metabolism-related fatty liver disease, drug-induced liver injury; 4. Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging). 5. 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. 6. 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 7. Received solid organ or bone marrow transplant. 8. 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). 9. Currently receiving therapy with immunomodulators (e.g. corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion. 10. Complicated with uncontrollable cardiovascular and cerebrovascular diseases. 11. 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. 12. Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance. 13. 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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing You'An Hospital, Capital Medical University | Beijing | |
China | The Second Xiangya Hospital, Central South University | Changsha | Hunan |
China | People's Hospital of Dongyang City | Dongyang | |
China | 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 | The Fifth People's Hospital of Suzhou | Suzhou | |
China | The Fifth People's Hospital of Wuxi | Wuxi |
Lead Sponsor | Collaborator |
---|---|
Ruijin Hospital | Jiangsu Hansoh Pharmaceutical Co., Ltd. |
China,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Evaluation the change from Baseline in HBV DNA | Change from baseline in HBV DNA | Week 48,Week 96,Week 144 | |
Secondary | Evaluation the proportion of Patients Achieving Hepatitis B Surface Antigen (HBsAg) Loss | Proportion of patients achieving Hepatitis B surface antigen (HBsAg) loss | Week 48,Week 96,Week 144 | |
Secondary | Evaluation the proportion of Patients Achieving HBsAg Seroconversion | Proportion of patients achieving HBsAg seroconversion | Week 48,Week 96,Week 144 | |
Secondary | Evaluation the proportion of Patients Achieving HBeAg Seroconversion | Proportion of patients achieving HBeAg seroconversion | Week 48,Week 96,Week 144 | |
Secondary | Evaluation the proportion of Patients Achieving HBeAg Loss | Proportion of patients Achieving HBeAg Loss | Week 48,Week 96,Week 144 | |
Secondary | Evaluation the change from Baseline in HBsAg | Change from baseline in HBsAg | Week 48,Week 96,Week 144 | |
Secondary | Evaluation the percentage of Participants with resistance | Percentage of participants with resistance | Week 48,Week 96,Week 144 | |
Secondary | Evaluation the change from Baseline in liver fibrosis | Change from baseline in liver fibrosis | Week 48,Week 96,Week 144 | |
Secondary | 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)) | Week 48,Week 96,Week 144 | |
Secondary | Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA < 20 IU/mL | Week 96,Week 144 | ||
Secondary | Evaluation the change from Baseline in Bone biomarker(ß-CTX and P1NP) | Week 48,Week 96,Week 144 | ||
Secondary | Evaluation the change from Baseline in sCR | Week 48,Week 96,Week 144 | ||
Secondary | AE ,SAE | Week 48,Week 96,Week 144 |
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