This single-arm study will evaluate the efficacy and safety of peginterferon alfa-2a in treatment-naive Baltic participants with Hepatitis B envelope antigen (HBeAg)-positive chronic Hepatitis B virus (HBV). All participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneously once weekly. Following 48 weeks of 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 less than 100 participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
180 mcg subcutaneously once per week for 48 weeks.
Unnamed facility
Tallinn, Estonia
Unnamed facility
Tallinn, Estonia
Unnamed facility
Tartu, Estonia
Unnamed facility
Riga, Latvia
Unnamed facility
Kaunas, Lithuania
Unnamed facility
Kaunas, Lithuania
Unnamed facility
Klaipėda, Lithuania
Unnamed facility
Vilnius, Lithuania
Unnamed facility
Vilnius, Lithuania
Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter (Copies/mL)
HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg positive participants were defined as those who had HBV DNA greater than (\>) 1,00,000 copies/mL at baseline. This outcome measured the number of participants with HBV-DNA levels \< 1,00,000 copies/mL at Week 72, who were defined as HBeAg positive at baseline.
Time frame: Week 72
Number of HBeAg Negative Participants With HBV-DNA < 10,000 Copies/mL
HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg negative participants were defined as those who had HBV DNA \>10,000 copies/mL at baseline. This outcome measured the number of participants with HBV DNA \<10,000 copies/mL at Week 72, who were defined as HBeAg negative at baseline.
Time frame: Week 72
Number of Participants With HBV-DNA < 400 Copies/mL
Time frame: Week 72
Percentage of Hepatitis B Surface Antigen (HBsAg) Negative Participants
HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HBsAg participants. Percentage of HBsAg negative participants were reported.
Time frame: Week 48 and Week 72
Percentage of Anti-HBs Positive Participants
HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HbsAg participants. Percentage of Anti-HBs positive participants were reported.
Time frame: Week 48 and Week 72
Mean Alanine Aminotransferase (ALT) Concentrations
Time frame: Week 48 and Week 72
Percentage of HBeAg Negative Participants
HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg positive participants. Percentage of HBeAg negative participants were reported.
Time frame: Week 48 and Week 72
Percentage of Anti-HBe Positive Participants
HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg participants. Percentage of Anti-HBe positive participants were reported.
Time frame: Week 48 and Week 72
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