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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
180 mcg SC injection QW for 48 weeks.
Unnamed facility
Auckland, New Zealand
Unnamed facility
Hamilton, New Zealand
Unnamed facility
New Plymouth, New Zealand
Unnamed facility
Riccarton, Christchurch, New Zealand
Unnamed facility
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.
Time frame: 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.
Time frame: End of 24-weeks follow-up (Week 72)
Number of Participants With HBV-DNA <400 Copies/mL
HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.
Time frame: 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.
Time frame: 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).
Time frame: Week 48 (end of treatment) and Week 72 (end of follow-up)
Number of Participants With HBeAg Seroconversion
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Rotorua, New Zealand
Unnamed facility
Whangarei, New Zealand
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).
Time frame: Week 48 (end of treatment) and Week 72 (end of follow-up)