Efficacy and safety of switching from entecavir to tenofovir for chronic hepatitis B patients with sustained viral supression: a randomized controlled trial
Not Applicable
Recruiting
- Conditions
- chronic hepatitis B
- Registration Number
- JPRN-UMIN000018406
- Lead Sponsor
- Toranomon Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1) Hypersensitivity for tenofovir 2) Presence of renal impairment 3) Presence of hypophosphatemia 4) Poorly-controlled diabetes 5) Poorly-controlled hypertension 6) History of hepatocellular carcinoma 7) Ineligible patients by atending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of patients who achieve the reduction of hepatitis surface antigen more than 0.5 log IU/mL for three years
- Secondary Outcome Measures
Name Time Method 1) The rates of negativity of hepatitis B e antigen for three years 2) The rates of negativity of hepatitis B surface antigen and achieving below 100 IU/mL or 1000 IU/mL of hepatitis B surface antigen levels for three years Predictive factors of the reduction of hepatitis B surface antigen 3) The rates of viral breakthrough for three years 4) The chenges of serum creatinine and phosphate for three years