Compare Continuing Lamivudine Plus Adefovir or Adefovir Versus Switching to Entecavir Plus Adefovir in Patients With LAM-resistant Chronic Hepatitis B
- Registration Number
- NCT02482272
- Lead Sponsor
- Asan Medical Center
- Brief Summary
The purpose of this study is to compare efficacy and safety of continuing Lamivudine plus Adefovir or Adefovir versus switching to Entecavir plus Adefovir in patients with LAM-resistant chronic hepatitis B who have suboptimal response to Lamivudine plus Adefovir or Adefovir
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
- Chronic hepatitis B
- Age ≥ 20 year old
- Currently taking Lamivudine and Adefovir combination therapy or Adefovir monotherapy for chronic HBV infection for 24 weeks
- Proven Lamivudine resistant mutation
- HBV DNA levels at screening ≥ 15 IU/mL
- Females must be post-menopausal, unable to conceive, or test negative for pregnancy via urine test
- Patient is able to give written informed consent prior to study start and to comply with the study requirements
- A history or current of decompensated cirrhosis or hepatocellular carcinoma
- Currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy
- Co-infected with HCV or HIV
- A history of organ transplantation
- Pregnant or breast-feeding
- Current clinically relevant of abuse of alcohol or drugs.
- Significant immunocompromised, gastrointestinal, renal(serum creatinine ≥ 1.5 mg/dL), hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic, allergic disease or medical illness that in the investigator's opinion might interfere with therapy
- malignancy in previous 5 years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lamivudine plus Adefovir or Adefovir Adefovir Lamivudine+Adefovir or Adefovir for 48 weeks Entecavir plus Adefovir Adefovir Entecavir+Adefovir for 48 weeks Entecavir plus Adefovir Entecavir Entecavir+Adefovir for 48 weeks Lamivudine plus Adefovir or Adefovir Lamivudine Lamivudine+Adefovir or Adefovir for 48 weeks
- Primary Outcome Measures
Name Time Method Proportion of patients with HBV DNA<15IU/mL week 48
- Secondary Outcome Measures
Name Time Method Proportion of patients with ALT normalization Day1, week12, week 24, week 36, week 48 Assessment the safety in all patients (composite measure of AE, labs, phys. exam, vital signs) week 48 Composite outcome measure consisting of multiple measures, including:
1. Number of patients with Adverse events( including SAEs)
2. Frequency and severity of Abnormalities in laboratory examinations; BUN, Albumin, AST, ALT,GGT, Creatinine, Hemoglobin, Hematocrit, Platelet Count, Prothrombin time
3. Number of patients with Abnormalities in physical examinations; Eyes/Ears/Nose/Throat, Respiratory, Cardiovascular, Dermatological, Abdominal, Musculoskeletal, Other
4. Number of patients with Abnormalities in vital signs ; pulse rate( beats per minute), Blood pressure(mmHg), Height(cm), weight(kg)Proportion of patients with HBeAg loss and/or seroconversion Day1, week12, week 24, week 36, week 48 The change of HBsAg from the baseline week 48 Proportion of patients with HBsAg loss and/or seroconversion week 24, week 48 Proportion of patients with HBV DNA<15IU/mL Day1, week12, week 24, week 36, week 48 The change of HBV DNA from the baseline week 48 Proportion of patients who experienced virologic breakthrough week 48
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of