Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B

Study Overview
=================
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

Official Title
-----------------
A Randomized Design Study to Compare the Efficacy of Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B: Role of Host and Viral Factors Associated With Treatment Response

Conditions
-----------------
Chronic Hepatitis B

Intervention / Treatment
-----------------
* Drug: PEG-IFN and entecavir


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: drug combination<br> | Drug: PEG-IFN and entecavir<br>* 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.<br>* Other names: baraclude;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatitis B, HBeAg, pegylated interferon, entecavir