NCT02201407

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

Open, Multicenter, Local, Non-Randomized, Non-Interventional Study in Patients With Chronic Hepatitis B Receiving Therapy With PEGASYS® (Peginterferon Alfa-2a 40kD) - PRO B

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2014-12-18
• Primary completion: 2017-04-10
• Completion: 2017-04-10
• First posted: 2014-07-28
• Last updated: 2017-08-31

Locations

6 sites across 1 country: Serbia