A study to comparison of tenofovir monotherapy with entecavir-adefovir combination in suboptimal responder for lamivudine-adefovir rescue therapy in chronic hepatitis B patients with YMDD mutatio
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0000627
- Lead Sponsor
- Soon Chun Hyang University Hospital Cheonan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
1) Age, 20 Years to 75 Years
2) HBsAg positive at least 6 months or more
3) Confirmed emergence of YMDD mutations (rtM204) with/without compensatory mutation (rtL180) with test for mutation profile and with virologic breakthrough (? serum HBV DNA > 1 log IU/mL at any time before screening
4) Received ADV-LAM combination therapy at least 24 weeks
5) Serum HBV DNA positive in real-time PCR assay despite continued preceding LAM and ADV combination therapy
6) Serum HBV DNA >60 IU/mL at screening for this study
1) Confirmed emergence of such drug resistant mutations (rtI169, rtT184, rtS202, rtM250) at any time before screening
2) Patient with decompensated cirrhosis (uncontrolled ascites, history of variceal bleeding, history of hepatic encephalopathy, Child-Pugh score > 8)
3) Patient has evidence of renal insufficiency defined as eGFR < 60 ml/min (using the Cockcroft-Gault equation)
4) Patient has received interferon or other immunomodulatory treatment for HBV infection in the 6 months before screening for this study.
5) Patient has medical condition that requires concurrent use of systemic corticosteroid or other immunosuppressive agent (including chemotherapeutic agent)
6) Patient is currently abusing alcohol (more than 40 g/day in men, 20 g/day in women) or illicit drugs
7) Patient has concomitant other chronic viral infection (HCV or HIV)
8)Patient has one or more additional known primary or secondary causes of liver disease, other than hepatitis B (e.g., autoimmune hepatitis, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson's Disease, other congenital or metabolic conditions affecting the liver, congestive heart failure or other severe cardiopulmonary disease, etc.).
9) Patient is pregnant or breastfeeding
10) Patient has a history of HCC or findings suggestive of possible HCC, such as suspicious foci on imaging studies. In patients with such findings, HCC should be ruled-out prior to randomizing the patient for the present study.
11) A history of treated malignancy (other than HCC) is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding three years.
12) Patient has severe bone disease (osteomalacia, chronic osteomyelitis, osteogenesis imperfect, osteochondroses)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with complete virological response (HBV-DNA < 60 IU/mL) at week 96
- Secondary Outcome Measures
Name Time Method Proportion of patients with resistance mutations to adefovir, entecavir, or tenofovir;Changes in serum HBV DNA level and mean levels during 96 weeks of treatment;Proportion of patients with normal ALT ;Proportion of patients with HBeAg loss or seroconversion;Changes in serum HBsAg levels during 96 weeks of treatment;Proportion of patients with developing adverse event and fatal complications, such as decompensated cirrhosis, hepatocellular carcinoma (HCC);Drug adherence and economic evaluations