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

Completed

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: Peginterferon alfa-2a

• Registration Number: NCT02201407
• Lead Sponsor: Hoffmann-La Roche

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-22
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-28
• Study Start: 2014-12-18
• Primary Completion: 2017-04-10
• Study Completion: 2017-04-10
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-30
• Last Update Posted: 2017-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CHB Participants Treated With Peginterferon alfa-2a	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).

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg)- Positive CHB Achieving Sustained Immune Control	Week 72	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.
Percentage of Participants With HBeAg-Negative CHB Achieving Sustained Immune Control	Week 72	Sustained immune control is defined as a combined response: HBV DNA levels \<2000 IU/mL and ALT normalization.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance or Seroconversion	Week 72
Percentage of Participants With HBeAg-Positive CHB Achieving Combined Response	Week 48	Combined response is defined as: post-treatment HBeAg seroconversion, HBV DNA levels \<2000 IU/mL, and ALT normalization.
Percentage of Participants With HBeAg-Negative CHB Achieving Combined Response	Week 48	Combined response is defined as: HBV DNA levels \<2000 IU/mL and ALT normalization.
Percentage of Participants With Serious Adverse Events (SAEs) and Non-SAEs	Up to 72 weeks

Trial Locations

Locations (6)

Clinical Center Zemun; 🇷🇸 Belgrade, Serbia

Clinic for Gastroenterology and Hepatology; 🇷🇸 Belgrade, Serbia

Clinical Center Vojvodine; Clinic for Infectious Diseases; Clinic for Hematology; 🇷🇸 Novi Sad, Serbia

Clinic for Infectious Diseases CC Kragujevac; 🇷🇸 Kragujevac, Serbia

Clinical Center of Serbia; Institute For Infectious Diseases; 🇷🇸 Belgrade, Serbia

Clinic for Infectious Diseases CC Nis; 🇷🇸 NIS, Serbia