Chronic Hepatitis B
Conditions
Keywords
hepatitis B, HBeAg, pegylated interferon, entecavir
Brief summary
The outcome of treatment of chronic hepatitis B is determined by viral and host interaction, thus the combination therapy of immunomodulator (PEG-IFN) and potent antiviral drug (entecavir) should improve the response rate. In addition, the simultaneous assessment of viral and host genetic factors associated with SVR may help to identify predictors of treatment outcomes, which will in turn significant reduce the cost/effect of therapy
Interventions
DRUGPEG-IFN and entecavir
The patients will be randomized in approximately 1:1 ratio into one of 2 treatment regimens; to receive PEG-IFN alpha-2b (1.5 microgram/kg/week) plus entecavir (0.5 mg/day) or PEG-IFN alpha-2b (1.5 microgram/kg/week) alone for 48 weeks by using pre-generated randomization schedule.
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Men and women 18 to 65 years of age * Patients with HBeAg-negative chronic hepatitis B * Positive for HBsAg for at least 6 months, negative for anti-HBs and HBeAg * Serum HBV DNA levels ≥ 2,000 IU/mL at screening * Increased alanine aminotransferase (ALT) levels \[greater than the upper limit of normal (ULN) and less than 10xULN} * No signs or symptoms of advanced liver disease * Patient has had a liver biopsy within 1 year of screening
Exclusion criteria
* Patient had previous treatment with IFN, peg-IFN, and/or entecavir * Patient has evidence or history of chronic hepatitis not caused by HBV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis * Patient has co-infection with hepatitis C virus and/or human immunodeficiency virus * Patients with liver cancer * Female patient is pregnant, lactating, expecting to conceive or donate eggs, or is of childbearing potential throughout treatment. * Patient has any other condition that is contraindicated for treatment with PEG-IFN or entecavir * Patient has any condition or pre-study laboratory abnormality, or history of any illness, which in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether a combination of PEG-IFN and entecavir improves the rate of sustained response and HBsAg clearance in patients with HBeAg-negative chronic hepatitis B | 24 weeks post treatment |
Secondary
| Measure | Time frame |
|---|---|
| To determine host factors and viral factors associated with response to PEG-IFN alone or PEG-IFN plus entecavir treatment | 24 weeks post treatment |
Countries
Thailand
Contacts
Primary ContactPisit Tangkijvanich, M.D.
Outcome results
None listed