HBsAg seroclearance in non-cirrhotic, HBeAg-negative chronic hepatitis B patients who discontinue tenofovir or entecavir
- Conditions
- HBsAg seroclearanceHBsAg seroclearance,HBeAg CHB onfection,Tenofovir,Entercavir,Dicontinuation
- Registration Number
- TCTR20190609001
- Lead Sponsor
- Faculty of Medicine Siriraj Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 420
1. Age > 18 years old
2. Chronic hepatitis B eAg negative (ตั้งà¹à¸•à¹ˆà¹à¸£à¸à¸§à¸´à¸™à¸´à¸ˆà¸‰à¸±à¸¢)
3. On treatment of TDF or ETV at least 3 years
4. HBV DNA < 10 IU/ml at least 2 years before enrollment
5. No evidence of advanced fibrosis (Liver biopsy METAVIR > F3 )
6. No history of hepatic decompensation
7. CTP A (serum total bilirubin <2 mg/dl, serum albumin>3.5 mg/dl, INR <1.7)
8. CBC: Hemoglobin > 12 gm/dL, platelets > 100,000 mm3
1. Transient elastography > 10 at least 6 months before enrollment
2. Creatinine clearance < 50
3. Poor compliance
4. Co-existing hepatocellular carcinoma or others malignancy
5. Co-existing with HIV or HCV infection
6. Pregnancy or breast feeding
7. Diagnosis of chronic liver disease from others etiology eg. AIH , Alcoholic liver disease
8.On immunosuppresive drugs or Post organ transplant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HBsAg seroclearance 48 week after discontinuation of NUCs prevalance of HBsAg seroclearance
- Secondary Outcome Measures
Name Time Method Association factors of HBsAg seroclearance at baseline before discontinuation of NUCs quantitative HBsAg, HBVcrAg, HBV RNA ,HBsAg seroconversion 48 week after discontinuation of NUCs prevalance of HBsAg seroconversion,Virological and clinical relapse at 12 ,24, 36 ,48 wk Rate of virological and clinical relapse,Adverse events at 12 ,24, 36 ,48 wk Hepatic encephalopathy, Liver failure, Death