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

NCT ID: NCT02201407

Last Updated: 2017-08-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-18
• Study Completion Date: 2017-04-10

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).

Conditions

Hepatitis B, Chronic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Peginterferon alfa-2a

Intervention Type: DRUG

Peginterferon alfa-2a treatment according to standard of care, current summary of product characteristics and in line with the local labeling.

Interventions

Peginterferon alfa-2a

Peginterferon alfa-2a treatment according to standard of care, current summary of product characteristics and in line with the local labeling.

Intervention Type: DRUG

Other Intervention Names

PEGASYS

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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

Countries

Serbia

Other Identifiers

ML29062

Identifier Type: -

Identifier Source: org_study_id