Effectiveness of TAF in Reducing Clinical Events in CHB Patients Beyond Treatment Indications by Current Guidelines
- Conditions
- Chronic Hepatitis b
- Registration Number
- NCT03753074
- Lead Sponsor
- Young-Suk Lim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 780
Inclusion Criteria: Patients must meet all of the following criteria to be eligible to<br>participate in the study<br><br> 1. Patient must have the ability to understand and sign a written informed consent<br> form; consent must be obtained prior to initiation of study procedures<br><br> 2. Male or female, 40 to 80 years of age<br><br> 3. Positive for HBsAg or HBV DNA for at least 6 months or more<br><br> 4. HBeAg positive or negative<br><br> 5. No evidence of liver cirrhosis (platelet count =100,000/mm3)<br><br> 6. serum HBV DNA = 4 log10 IU/mL and = 8 log10 IU/mL<br><br> 7. Serum ALT level <70 if male, <50 if female<br><br> 8. Estimated creatinine clearance = 30 ml/min based on serum creatinine as measured at<br> the screening evaluation<br><br> 9. Patient is willing and able to comply with all study requirements<br><br>Exclusion Criteria: Patients who meet any of the following exclusion criteria are not to<br>be enrolled in this study<br><br> 1. Co-infection with HCV, HDV, HIV (Confirmed by nucleic acid tests)<br><br> 2. Abusing alcohol (more than 60 g/day) or illicit drugs<br><br> 3. Patients with history of hepatic decompensation (e.g., ascites, encephalopathy or<br> variceal hemorrhage)<br><br>4-1) Evidence of cirrhosis, including any of follows:<br><br> 1. Platelet count <100,000/mm3<br><br> 2. Esophagogastric varices on endoscopy<br><br> 3. Evidence of clinically significant portal hypertension<br><br> 4. Fibroscan = 12.0 kPa (If the test was done in 3 months before the time of<br> screening.) and confirmed to have liver cirrhosis by an investigator<br><br>4-2) 40=ALT levels<70 IU/L (males) or 40= ALT levels<50 IU/L (females) with evidence of<br>significant fibrosis(F2; =7.2 kPa) as measured by either liver biopsy, Fibroscan or MR<br>elastograpy performed within 3 months.<br><br> 5. Received interferon or other immunomodulatory treatment for HBV infection in the 12<br> months before screening for this study<br><br> 6. Medical condition that requires concurrent use of systemic corticosteroid or other<br> immunosuppressive agents<br><br> 7. Received solid organ or bone marrow transplant<br><br> 8. Known hypersensitivity to study drugs, metabolites, or formulation excipients<br><br> 9. Any other clinical condition or prior therapy that, in the opinion of the<br> Investigator, would make the patient unsuitable for the study or unable to comply<br> with dosing requirements<br><br> 10. Use of investigational agents within 6 months of screening, unless allowed by the<br> Sponsor or Investigator<br><br> 11. Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion<br> of the Investigator<br><br> 12. Any malignant tumor in the preceding five years. However, a history of treated<br> malignancy (other than HCC) is allowable if the patient's malignancy has been in<br> complete remission, off chemotherapy and without additional surgical intervention,<br> during the preceding three years<br><br> 13. Pregnant or breastfeeding or willing to be pregnant<br><br> 14. Participating in other clinical trials to administer medication. However, it is<br> possible to participate if it is not an antiviral agent or immunosuppressant related<br> clinical trial.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the occurrence of composite events during follow-up observation
- Secondary Outcome Measures
Name Time Method