Chronic Hepatitis B
Conditions
Keywords
entecavir
Brief summary
Open-labeled, Prospective, Randomized, Multi-center, Interventional, Phase IV study.
Detailed description
The purpose of this study is to evaluate the non-inferiority and safety in terms of HBV DNA undetectability comparing Baraclude Tab. in HBeAg(+) chronic hepatitis B patients treated with long-term Baraclude Tab.
Interventions
DRUGCavir
0.5mg/day
DRUGBaraclude
0.5mg/day
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients (over the19 years of age) currently taking Baraclude® monotherapy for chronic HBV infection for at least 24 month with \< HBV DNA 60 IU/mL level, HBeAg positive and HBeAb negative status at screening.
Exclusion criteria
* Patients are diagnosed Hepatitis cancer and hepatocellular carcinoma (HCC) * Patient has concomitant other chronic viral infection (HAV/Hepatitis C Virus (HCV)/Hepatitis D Virus(HDV)/HIV) * Patient had documented resistance mutations at any time before or at screening * Patient has clinically confirmed alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency and Wilson's Disease. * Patient has received antiviral agent including interferon other than Baraclude within 24 months before screening for this study. * Patient has received immunosuppressive agent within 24 weeks before screening or corticosteroids for 4 weeks. * Clinical signs as indicated by any one of the following: Ccr(Cockroft-Gault) \< 50ml/min, Total bilirubin \> 3.0 mg/dl, Albumin \< 2.7 g/dl, Prothrombin time \> INR 2.3 * Patient is pregnant or breastfeeding or willing to be pregnant * Patient has malignancy except for thyroid cancer and Borderline malignancy.a history of treated malignancy is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding five years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients with maintenance of HBV DNA undetectability | 48weeks | analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients with HBeAg seroclearance | at week 12, 24, 36 and 48 of treatment | analysis |
| The proportion with HBsAg seroclearance | at week 48 of treatment | analysis |
| The proportion with HBeAg seroconversion and HBsAb positive | at week 48 of treatment | analysis |
| Changes in serum HBV DNA levels | at week 48 of treatment | analysis |
| The proportion of patients with HBeAg seroconversion | at week 12, 24, 36 and 48 of treatment | analysis |
| Changes in ALanine amino Transferase (ALT) | at week 48 of treatment | analysis |
| Proportion of patients with virologic breakthrough | at week 48 of treatment | virologic breakthrough is defined as the increase in serum HBV DNA (\>60IU/ml) as determined by at least 2 consecutive measurements of at least 3 month apart, during continued treatment |
| Changes in EuroQoL Five Dimensions Questionnaire-3L(EQ-5D-3L) | at week 48 of treatment | questionnaire |
| Changes in HBsAg titer | at week 48 of treatment | analysis |
Countries
South Korea
Contacts
Primary ContactHanmi Pharmaceutical
Backup ContactEunSol Kim
Outcome results
None listed