A Study of Peginterferon Alfa-2a in Participants With Chronic Hepatitis B Virus (HBV) in an Expanded Access Program

Study Overview
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Brief Summary
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This is an expanded access, multicenter, national, open-label, and non-randomized study to analyze the safety of peginterferon alfa-2a in participants with hepatitis B e antigen (HBeAg) positive and HBeAg negative chronic HBV infection. All participants will receive 48 weeks treatment of peginterferon alfa-2a monotherapy, followed by a 24 week treatment-free follow-up period.

Official Title
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Expanded Access Program of PEGASYS® (Peg Interferon Alpha-2a 40 KD) 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-cirrhotic participants Hepatitis B surface antigen (HBsAg) positive for at least 6 months Hepatitis B surface antibody (anti-HBs) negative Elevated serum alanine aminotransferase (ALT) greater than (>) upper limit of normal (ULN) but less than or equal to (</=) 10 times of ULN HBeAg positive participants: HBV DNA > 500,000 copies/mL, HBeAg negative participants: HBV DNA >100,000 copies/mL by polymerase chain reaction (PCR) Participants with chronic hepatitis B (CHB) who are treatment-naive No previous antiviral treatment with interferon (IFN: standard or pegylated) or with a nucleoside analogue For women of childbearing potential: negative urine or serum pregnancy test documented within the 24-hour period prior to the first dose of test drug. Willingness to use reliable contraception during the study and for 3 months after treatment completion Exclusion Criteria: Previous antiviral or IFN-based therapy for CHB before enrolment Pregnant or breast feeding women participants Evidence of decompensated liver disease Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV) History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis Previous or current hepatocellular carcinoma History of or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease Alpha-fetoprotein levels of >100 nanograms (ng)/mL Severe psychiatric disease History of a severe seizure disorder or current anticonvulsant use History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the participant, in the opinion of the investigator, unsuitable for the study Thyroid disease uncontrolled by prescribed medications Evidence of severe retinopathy Alcohol intake more than 3 standard drinks per day for men and 2 standard drinks per day for women

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HBeAg Negative Participants<br>HBeAg negative participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) injection once weekly (QW) for 48 weeks followed by a 24 weeks treatment-free follow-up period. | Drug: Peginterferon alfa-2a<br>* 180 mcg SC injection QW for 48 weeks.<br>* Other names: Pegasys;|
| Experimental: HBeAg Positive Participants<br>HBeAg Positive participants will receive peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period. | Drug: Peginterferon alfa-2a<br>* 180 mcg SC injection QW for 48 weeks.<br>* Other names: Pegasys;|

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-deoxy Ribonucleic Acid (HBV-DNA) Less Than (<) 100,000 Copies Per Milliliter (Copies/mL) | HBV-DNA was assessed in plasma samples using quantitative Roche polymerase chain reaction (PCR) or Taqman tests. | End of 24-weeks follow-up (Week 72) | 
| Number of Participants With HBV-DNA <20,000 Copies/mL | HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests. | End of 24-weeks follow-up (Week 72) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With HBV-DNA <400 Copies/mL | HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests. | Week 48 (end of treatment) and Week 72 (end of follow-up) | 
| Number of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion | HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs). Both HBeAg positive and negative participants were HBsAg positive at baseline and absence of HBsAg (seroconversion) was analyzed. | Week 48 (end of treatment) and Week 72 (end of follow-up) | 
| Number of Participants With Normalization of Alanine Aminotransferase (ALT) Level | ALT is an enzyme found mainly in liver and is measured to check if the liver is damaged or diseased. In case of liver damage or disease, the liver releases ALT into the blood stream and the ALT level increases. Normal ALT level = less than upper limit of normal (40 units per liter). | Week 48 (end of treatment) and Week 72 (end of follow-up) | 
| Number of Participants With HBeAg Seroconversion | HBeAg seroconversion for HBeAg positive participants was defined as the loss of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe). | Week 48 (end of treatment) and Week 72 (end of follow-up) |