Chronic Hepatitis b
Conditions
Brief summary
This study is a multi-center, prospective, real-world study, males and non-pregnant, non-lactating female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with other HBV antivirals. During 36 months of treatment, efficacy and safety will be evaluated.
Detailed description
This study is a multi-center, prospective, real-world study, aiming to investigate the use of TAF in routine clinical management of chronic hepatitis B patients and evaluate its effectiveness and safety across a heterogeneous population in China. Approximately 500 patients will take part in this study, 10 sites will be included which distribute in China's major cities, thus each site will enroll 50 patients. Male or female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with other HBV antivirals. During 36 months of treatment, efficacy and safety will be evaluated.
Interventions
DRUGTenofovir Alafenamide
The dose of tenofovir alafenamide (TAF) will be 25mg tablet taken orally once daily with food for 36 months, patients will be treated with TAF alone or in combination with anti-HBV agents
Sponsors
Gilead Sciences
Tongji Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Must have the ability to understand and sign a written informed consent form, consent must be obtained prior to initiation of study procedures 2. Adult males and nonpregnant, nonlactating females 3. Documented evidence of chronic HBV infection previously 4. TAF naive
Exclusion criteria
1. Patents who were TAF experienced 2. Women who are breastfeeding 3. Pregnant females 4. Co-infection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV 5. Evidence of hepatocellular carcinoma (Note: if screening alpha-fetoprotein (AFP) is \< 50 ng/mL no imaging study is needed; however, if the screening AFP is \> 50 ng/mL an imaging study is required) 6. Chronic liver disease of non-HBV etiology (e.g., hemochromatosis, fatty liver disease, cholangitis) 7. Current evidence of Child-Pugh Score C decompensated liver disease,or moderate to severe ascites, Grade III-IV hepatic encephalopathy 8. Abnormal hematological and biochemical parameters, including: 9. Albumin \< 2.8 mg/ dL 10. International normalized ratio (INR) \> 2.3 X ULN (unless stable on anticoagulant regimen) 11. Total bilirubin \> 3 X ULN 12. Patient develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity 13. Received solid organ or bone marrow transplant, except patients who underwent liver or kidney transplantation 14. Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (e.g., basal cell skin cancer). Individuals under evaluation for possible malignancy are not eligible. 15. Individuals receiving ongoing therapy with drugs not to be used with TAF or individuals with a known hypersensitivity to study drugs, metabolites, or formulation excipients 16. Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements 17. Use of investigational agents within 3 months of screening, unless allowed by the sponsor 18. Patients included in another trial or having been given investigational drugs within 12 weeks prior to screening 19. Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance 20. Inability or unwillingness to provide informed consent or abide by the requirements of the study 21. In addition to the above
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| proportion of participants with HBV DNA < 20 IU/mL | 36 months | proportion of participants with HBV DNA \< 20 IU/mL as measured by the COBAS TaqMan HBV Test (Roche Molecular Diagnostics, Pleasanton, CA, USA), with taken at 36 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients with HBV DNA <300 copies/mL | 12 months | The proportion of patients with HBV DNA \<300 copies/mL at 12 months |
| The proportion of patients with HBV DNA <300 copies/mL IU/mL | 24 months | The proportion of patients with HBV DNA \<300 copies/mL at 24 months |
| Proportion of participants with Hepatitis B e Antigen (HBeAg) Loss | 36 months | Proportion of participants with Hepatitis B e Antigen (HBeAg) Loss at 36 months |
| Proportion of participants with seroconversion to Anti-Hepatitis B e-Antigen (Anti-HBe) | 36 months | Proportion of participants with seroconversion to Anti-Hepatitis B e-Antigen (Anti-HBe) at 36 months |
| The proportion of patients with HBV DNA < 20 IU/mL | 12 months | The proportion of patients with HBV DNA \< 20 IU/mL at 12 months |
| Change from baseline in fibrosis as assessed by Fibroscan® | 36 months | Change from baseline in fibrosis as assessed by Fibroscan® at 36 months |
| Percent Change from baseline in Bone Mineral Density (BMD) | 36 months | Percent Change from baseline in Bone Mineral Density (BMD) at 36 months |
| Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) | 36 months | Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) at 36 months |
| the rate of mother-to-child transmission of HBV | at postpartum 6 months | For unplanned pregnant subjects, if not withdrawn, mother-to-child transmission (MTCT) rate |
| Proportion of participants with Normal Alanine Aminotransferase (ALT) | 36 months | Proportion of participants with Normal Alanine Aminotransferase (ALT) at 36 months |
Countries
China
Contacts
Primary ContactQin Ning, MD., Ph.D.
Backup ContactDi Wu, MD., Ph.D.
Outcome results
None listed