A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B.

Study Overview
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Brief Summary
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This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c. weekly for 48 weeks, followed by 48 weeks 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
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PEGASYS® (Peginterferon Alpha-2a 40KD) in Patients With HBeAg-positive and HBeAg-negative Chronic Hepatitis B

Conditions
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Hepatitis B, Chronic

Intervention / Treatment
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* Drug: peginterferon alfa-2a [Pegasys]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients, 18-70 years of age; chronic hepatitis B; Hepatitis B Virus (HBV) DNA >100,000 copies/mL. Exclusion Criteria: previous antiviral or interferon-based therapy for chronic hepatitis B in past 6 months; evidence of decompensated liver disease; history or evidence of a medical condition associated with chronic liver disease other than viral hepatitis; coinfection with hepatitis A, C or D, or HIV.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peginterferon Alfa-2a<br> | Drug: peginterferon alfa-2a [Pegasys]<br>* 180 micrograms sc weekly for 48 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of HBeAg Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid <100,000 Copies Per mL | This study included four Hepatitis B Early Antigen (HBeAg) positive participants. Participants with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <100,000 copies/mL were reported. | Week 96 | 
| Number of HBeAg Negative Participants With HBV DNA < 20,000 Copies Per mL | This study included 14 HBeAg negative participants. Participants with HBV DNA <20,000 copies/mL were reported. | Week 96 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion | Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of Hepatitis B surface antibody (HBsAb). Sustained HBe seroconversion is defined as loss of HBeAg and presence of hepatitis B e-antibody (HBeAb). This study included 4 HBeAg positive participants. | Week 96 | 
| Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT | Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of HBsAb. This study included 14 HBeAg negative participants. | Week 96 | 
| Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) | All participants who received at least one dose of the study drug were analysed. Number of participants with any adverse events and any serious adverse events are reported. | Up to Week 96 | 
| Mean Change in Laboratory Parameters (ALT Levels) | Mean Change in Laboratory parameters (ALT levels) is reported. | From Screening (Day 0) to Week 96 |