KCT0004185Not yet recruiting未知
Efficacy and Safety of Vireal®(Tenofovir Disoproxil Orotate) in Chronic Hepatitis B Patients Previously Treated with Viread®(Tenofovir Disoproxil Fumarate) : Multi-center, Open Label, Prospective, Investigator Initiative Study
Soon Chun Hyang University Hospital Seoul0 sites64 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 64
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 19(Year) to o Limit (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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