A Randomized Trial to Compare Antiviral Efficacy and Safety in the Fasted state versus the Fed state in Chronic Hepatitis B patients with Entecavir treatment
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0003031
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 88
1. Subjects with chronic hepatitis B who are currently taking entecavir for =48 weeks
2. Subjects aged 19–75 years
3. Subjects with HBV DNA <20 IU/mL at screening
4. Subjects with HBeAg-Positive or HBeAg-negative diagnosed at the screening visit
1. Subjects with decompensated liver disease (total bilirubin of greater than 2 times the ULN, albumin less than 3 g/dL, prothrombin time longer than 3 seconds of normal value, ascites or jaundice, history of variceal bleeding, hepatic encephalopathy) or hepatocellular carcinoma
2. Treatment-experienced subjects (those who previously received
treatment with any oral antiviral agent except entecavir) or subjects with lamivudine resistance.
3. Currently receiving therapy with immunomodulators, cytotoxic chemotehrapy or corticosteroids
4. Subjects co-infected with hepatitis C, hepatitis D, or HIV.
5. Received solid organ or bone marrow transplant
6. Women who are pregnant or breastfeeding
7. Less than 60ml/min of creatinine clearance diagnosed at the screening visit
8. Subjects with hemoglobin less than 8 g/dL
9. Subjects with neutrophil counts less than 1,000/uL
10. Subjects with ALT greater than ten times the ULN
11. Subjects who participated in other clinical trials within three months before enrollment in this trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of participants with serum HBV DNA < 20 IU/m
- Secondary Outcome Measures
Name Time Method Proportion of participants with serum HBV DNA < 20 IU/mL;Proportion of participants with serological response: seroconversion to anti-HBe in HBeAg-positive participants;Proportion of participants with normal ALT;Change from baseline in HBV DNA levels;Proportion of participants with virological breakthrough;Safety profiles