Hepatitis B, Chronic
Conditions
Brief summary
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).
Interventions
DRUGPeginterferon alfa-2a
Peginterferon alfa-2a treatment according to standard of care, current summary of product characteristics and in line with the local labeling.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HBeAg positive or HBeAg negative serologically proven CHB with or without cirrhosis (histologically verified at some point in the past) * Baseline HBV DNA greater than (\>) 2000 IU/mL * Elevated serum ALT \> upper limit of normal (ULN) * Participants treated with previous NAs therapy are eligible for this study
Exclusion criteria
* Participants who have contraindications for peginterferon alfa-2a in accordance with the approved summary of product characteristics (for example, severe psychiatric diseases, immunological diseases, severe hepatic dysfunction or decompensated cirrhosis of the liver severe retinopathy or thyroid dysfunction, autoimmune hepatitis, history of severe pre-existing cardiac disease, or hypersensitivity to the active substance, to alpha interferons, or to any of the excipients) * Participants with ALT \> 10 times of ULN or evidence of hepatocellular carcinoma * Participants with serological evidence of co-infection with hepatitis A virus, hepatitis C virus, human immunodeficiency virus, or hepatitis D virus * Participants with decompensated liver disease * Pregnant or breast-feeding women * A history of liver transplantation or planned for liver transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg)- Positive CHB Achieving Sustained Immune Control | Week 72 | 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. |
| Percentage of Participants With HBeAg-Negative CHB Achieving Sustained Immune Control | Week 72 | Sustained immune control is defined as a combined response: HBV DNA levels \<2000 IU/mL and ALT normalization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance or Seroconversion | Week 72 | — |
| Percentage of Participants With HBeAg-Positive CHB Achieving Combined Response | Week 48 | Combined response is defined as: post-treatment HBeAg seroconversion, HBV DNA levels \<2000 IU/mL, and ALT normalization. |
| Percentage of Participants With HBeAg-Negative CHB Achieving Combined Response | Week 48 | Combined response is defined as: HBV DNA levels \<2000 IU/mL and ALT normalization. |
| Percentage of Participants With Serious Adverse Events (SAEs) and Non-SAEs | Up to 72 weeks | — |
Countries
Serbia
Outcome results
None listed