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

Roche

Status: Completed

Conditions: Hepatitis B, Chronic

Treatments: Drug: Peginterferon alfa-2a

Study type: Observational

Funder types: Industry

Identifiers

NCT02201407

ML29062

Details and patient eligibility

About

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).

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

CHB Participants Treated With Peginterferon alfa-2a

Description:

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).

Treatment:

Drug: Peginterferon alfa-2a