A Study of Peginterferon Alfa-2a (Pegasys) in Participants With Hepatitis B E-Antigen (HBeAg)-Positive Chronic Hepatitis B Virus (HBV)

Study Overview
=================
Brief Summary
-----------------
This is a study of the efficacy and safety of peginterferon alfa-2a (Pegasys) in naive, interferon- or lamivudine-pretreated participants with HBeAg-positive chronic HBV. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Official Title
-----------------
Efficacy and Safety of Peginterferon Alfa-2a (40 KD) (Pegasys®) in Patients With HBeAg-Positive Chronic Hepatitis B

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

Intervention / Treatment
-----------------
* Drug: Peginterferon alfa-2a


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult participants between 18 to 65 years of age HBeAg-positive chronic HBV Treatment-naive, or have received and have not responded to or have relapsed on either conventional interferon or lamivudine therapy. Exclusion Criteria: Antiviral or interferon-based therapy for chronic HBV within 6 months of enrollment Co-infection with active hepatitis A, C or D virus or with human immunodeficiency virus (HIV) Evidence of decompensated liver disease Medical condition associated with chronic liver disease other than viral hepatitis.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (Naïve Participants)<br>Participants who never received any HBV treatment, will receive peginterferon alfa-2a (180 micrograms [mcg]) subcutaneously once weekly for 48 weeks. | Drug: Peginterferon alfa-2a<br>* Peginterferon alfa-2a will be administered at a dose of 180 mcg subcutaneously once weekly for 48 weeks.<br>* Other names: Pegasys;|
| Experimental: Group B (Conventional Interferon Pretreated Participants)<br>Participants who received conventional interferon treatment and had relapse or did not respond, will receive peginterferon alfa-2a (180 mcg) subcutaneously once weekly for 48 weeks. | Drug: Peginterferon alfa-2a<br>* Peginterferon alfa-2a will be administered at a dose of 180 mcg subcutaneously once weekly for 48 weeks.<br>* Other names: Pegasys;|
| Experimental: Group C (Lamivudine Pretreated Participants)<br>Participants who received lamivudine and had relapse or did not respond, will receive peginterferon alfa-2a (180 mcg) subcutaneously once weekly for 48 weeks. | Drug: Peginterferon alfa-2a<br>* Peginterferon alfa-2a will be administered at a dose of 180 mcg subcutaneously once weekly for 48 weeks.<br>* Other names: Pegasys;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with HBV deoxyribonucleic acid (DNA) less than (<) 100,000 copies per milliliters (copies/mL) |  | 72 weeks | 
| Percentage of participants with HBeAg seroconversion |  | 72 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who achieved HBV DNA levels below limit of detection |  | Weeks 48 and 72 | 
| Number of participants with HBsAg loss |  | Weeks 48 and 72 | 
| Number of participants with both Hepatitis B Surface Antigen (HBsAg) loss and presence of Anti-HBs |  | Weeks 48 and 72 | 
| Number of participants with alanine aminotransferase (ALT) normalization |  | Weeks 48 and 72 | 
| Number of participants with combined response (HBV DNA <100,000 copies/mL, HBeAg loss, and ALT normalization) |  | Weeks 48 and 72 | 
| Incidence of adverse events |  | up to 72 weeks |