This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180 micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow up.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once a week for 48 weeks
Unnamed facility
Busan, South Korea
Unnamed facility
Daegu, South Korea
Unnamed facility
Seoul, South Korea
Unnamed facility
Seoul, South Korea
Unnamed facility
Percentage of Participants With Hepatitis B Virus DNA <100,000 Copies/mL At Week 72
Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (EOF) period (24 weeks after the end of treatment) were classified as responders.
Time frame: Week 72
Percentage of Participants With Hepatitis B Virus e Antigen Loss At Week 72
Participants with loss of hepatitis B virus e antigen (HBeAg) at the EOF period (24 weeks after the end of treatment) were classified as responders.
Time frame: Week 72
Percentage of Participants With ALT Normalization At Week 48 and Week 72
Participants with ALT less than the upper limit of normal (ULN) at end of treatment (EOT) and EOF period were responders.
Time frame: Week 48 and Week 72
Percentage of Participants With Hepatitis B Virus DNA Below the Limit of Detection At Week 48 and Week 72
Participants with HBV-DNA below the limit of detection i.e. \<174 copies/mL at EOT and EOF period were responders.
Time frame: Week 48 and Week 72
Percentage of Participants With a Combined Response At Week 48 and Week 72
A responder with Combined Response was a participant with HBV-DNA\<100,000 copies/mL, HBeAg seroconversion (i.e. loss of HBeAg and presence of anti-HBe) and ALT normalization at EOT and EOF period.
Time frame: Week 48 and Week 72
Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion
A responder was a participant with loss of HBeAg and presence of anti-HBe at EOT and EOF period.
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Seoul, South Korea
Unnamed facility
Seoul, South Korea
Unnamed facility
Seoul, South Korea
Time frame: Week 48 and Week 72
Percentage of Participants With Loss of Hepatitis B Surface Antigen At Week 48 and Week 72
A responder was a participant who were analysed with loss of Hepatitis B Surface Antigen (HBsAg) at EOT and EOF period.
Time frame: Week 48 and Week 72
Percentage of Participants With Hepatitis B Surface Antigen Seroconversion At Week 48 and Week 72
A responder was a participant with loss of HBsAg and presence of anti-HBs at EOT and EOF period.
Time frame: Week 48 and Week 72
Number of Participants With Any Adverse Events and Any Serious Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Participants with any AEs and any SAEs have been presented.
Time frame: Up to Week 72