Hepatitis B, Chronic
Conditions
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
Interventions
DRUGLamivudine
Lamivudine 100mg/day orally
DRUGAdefovir
Adefovir 10mg/day orally
DRUGEntecavir
Entecavir 1mg/day orally
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with HBV DNA<15IU/mL | week 48 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of HBV DNA from the baseline | week 48 | — |
| Proportion of patients with ALT normalization | Day1, week12, week 24, week 36, week 48 | — |
| Proportion of patients with HBeAg loss and/or seroconversion | Day1, week12, week 24, week 36, week 48 | — |
| Proportion of patients with HBV DNA<15IU/mL | Day1, week12, week 24, week 36, week 48 | — |
| Proportion of patients with HBsAg loss and/or seroconversion | week 24, week 48 | — |
| Proportion of patients who experienced virologic breakthrough | 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) |
| The change of HBsAg from the baseline | week 48 | — |
Countries
South Korea
Contacts
Primary ContactDanbi Lee
Outcome results
None listed