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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHB Participants Treated With Peginterferon alfa-2a | As this is an observational study, treatment schedule will be at the clinician's discretion in accordance with local labeling and not directed by the protocol. Participants with CHB who are receiving peginterferon alfa-2a treatment according to standard of care, current summary of product characteristics, and in line with the local labeling will be followed for the duration of treatment with peginterferon alfa-2a (48 weeks) and up to 24 weeks after peginterferon alfa-2a treatment (72 weeks in total). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2a | Drug | Peginterferon alfa-2a treatment according to standard of care, current summary of product characteristics and in line with the local labeling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance or Seroconversion | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants receiving treatment for CHB with peginterferon alfa-2a according to standard of care and in line with the current summary of product characteristics and local labeling who have no contraindication to peginterferon alfa-2a therapy as per the local label. Target population are naïve participants (who have never received any HBV treatment) and previously treated participants with NAs.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for Gastroenterology and Hepatology | Belgrade | 11000 | Serbia | |||
| Clinical Center of Serbia; Institute For Infectious Diseases |
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|
| 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. | Week 48 |
| Percentage of Participants With Serious Adverse Events (SAEs) and Non-SAEs | Up to 72 weeks |
| Belgrade |
| 11000 |
| Serbia |
| Clinical Center Zemun | Belgrade | 11080 | Serbia |
| Clinic for Infectious Diseases CC Kragujevac | Kragujevac | 34000 | Serbia |
| Clinic for Infectious Diseases CC Nis | Niš | 18000 | Serbia |
| Clinical Center Vojvodine; Clinic for Infectious Diseases; Clinic for Hematology | Novi Sad | 21000 | Serbia |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
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