This open--label, multicenter, national observational study will investigate the effectiveness of standard of care treatment with peginterferon alfa-2a in participants with chronic hepatitis B (CHB). Participants who have never received any hepatitis B virus (HBV) treatment and participants previously treated with nucleos(t)ide analogs (NAs) are qualified for enrollment. The observation period is 48 weeks (peginterferon alfa--2a standard of care treatment) and for up to 24 weeks thereafter (72 weeks in total).
Study Type
OBSERVATIONAL
Enrollment
50
Peginterferon alfa-2a treatment according to standard of care, current summary of product characteristics and in line with the local labeling.
Clinic for Gastroenterology and Hepatology
Belgrade, Serbia
Clinical Center of Serbia; Institute For Infectious Diseases
Belgrade, Serbia
Clinical Center Zemun
Belgrade, Serbia
Clinic for Infectious Diseases CC Kragujevac
Kragujevac, Serbia
Clinic for Infectious Diseases CC Nis
Niš, Serbia
Clinical Center Vojvodine; Clinic for Infectious Diseases; Clinic for Hematology
Novi Sad, Serbia
Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg)- Positive CHB Achieving Sustained Immune Control
Sustained immune control is defined as a combined response: post-treatment HBeAg seroconversion, and HBV deoxyribonucleic acid (DNA) levels less than (\<) 2000 international units per milliliter (IU/mL), and alanine aminotransferase (ALT) normalization.
Time frame: Week 72
Percentage of Participants With HBeAg-Negative CHB Achieving Sustained Immune Control
Sustained immune control is defined as a combined response: HBV DNA levels \<2000 IU/mL and ALT normalization.
Time frame: Week 72
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance or Seroconversion
Time frame: Week 72
Percentage of Participants With HBeAg-Positive CHB Achieving Combined Response
Combined response is defined as: post-treatment HBeAg seroconversion, HBV DNA levels \<2000 IU/mL, and ALT normalization.
Time frame: Week 48
Percentage of Participants With HBeAg-Negative CHB Achieving Combined Response
Combined response is defined as: HBV DNA levels \<2000 IU/mL and ALT normalization.
Time frame: Week 48
Percentage of Participants With Serious Adverse Events (SAEs) and Non-SAEs
Time frame: Up to 72 weeks
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