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An Observational Study in Participants With Chronic Hepatitis B (CHB) Receiving Therapy With Peginterferon Alfa-2a 40 Kilodaltons (kD) (PEGASYS) - The PRO B Study
An Observational Study in Participants With Chronic Hepatitis B (CHB) Receiving Therapy With Peginterferon Alfa-2a 40 Kilodaltons (kD) (PEGASYS) - The PRO B Study

NCT02201407

CompletedN/A

Sponsor: Hoffmann-La Roche

Conditions: Hepatitis B, Chronic

Interventions: Peginterferon alfa-2a

Countries: Serbia

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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
Locations (6)
  • Belgrade, Serbia
  • Belgrade, Serbia
  • Belgrade, Serbia
  • Kragujevac, Serbia
  • Niš, Serbia
  • Novi Sad, Serbia