Efficacy and Safety of Vireal®(Tenofovir Disoproxil Orotate) in Chronic Hepatitis B Patients Previously Treated with Viread®(Tenofovir Disoproxil Fumarate)
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0004185
- Lead Sponsor
- Soon Chun Hyang University Hospital Seoul
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 64
1. age > 18 yrs
2. Patients who have taken VIREAD® for more than 48 weeks have less than 20 IU/mL of HBV DNA
3. HBeAg posive or negative
4. Patients who allow consent form and have a will for attendance for the study
1. HCV, HDV, or HIV positive
2. Decompensated cirrhosis (more than 1 below items)
- serum total bilirubin > 3 mg/dL
_ serum albumin < 2.8 g/dL
_ Prothrombin time prolongation more than 4 sec
_ Ascites or jaundice
_ The occurence of gastroesophageal varix bleeding or hepatic encephalopathy within 6 months
3. Patients who had liver transplantation
4. Diagnosis of HCC
5. Other malignancy
6. Corticosteroid or immune suppressant exposure more than 2 weeks within 3 months
7. Incontrollable DM
8. GFR increase more than 30% after tenofovir medication, or creatinine clearance < 50ml/min at baseline
9. galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
10. Pregnancy
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maintained virologic response;adverse events;renal function;occurrence of hepatocellular carcinoma,;blood test,;physical examination/vital sign
- Secondary Outcome Measures
Name Time Method HBV DNA change from Baseline (log10 IU/mL);The proportion of patients with normal ALT;HBeAg loss and/or seroconversion