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An Open-Label, Multicenter, National Observational Study in Patients With Chronic Hepatitis B Receiving Therapy With PEGASYS (Peginterferon Alfa-2a 40kD) - The PRO B Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: July 22, 2014
Last updated: November 1, 2016
Last verified: November 2016
This open-label, multicenter, national observational study will investigate the effectiveness of standard of care treatment with PEGASYS in patients with chronic hepatitis B (CHB). Patients who have never received any hepatitis B virus (HBV) treatment and patients previously treated with nucleos(t)ide analogs are qualified for enrollment. The observation period is 48 weeks (PEGASYS standard of care treatment) and for up to 24 weeks thereafter (72 weeks in total).

Hepatitis B, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Peginterferon Alfa-2a (PEGASYS) in theRapy of Patients With chrOnic Hepatitis B (CHB) - PRO B

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients with HBeAg-positive CHB acheiving sustained immune control, defined as a combined response: post-treatment HBeAg seroconversion, and HBV levels < 2,000 IU/ml, and ALT normalization [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
  • Percentage of patients with HBeAg-negative CHB acheiving sustained immune control, defined as combined response: HBV DNA levels < 2,000 IU/ml, and ALT normalization [ Time Frame: Week 72 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with HBeAg-positive CHB acheiving combined response: post-treatment HBeAg seroconversion, and HBV levels < 2,000 IU/ml, and ALT normalization [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Percentage of patients with HBeAg-negative CHB acheiving combined response: HBV DNA levels < 2,000 IU/ml, and ALT normalization [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Incidence of laboratory test abnormalities [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: December 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients receiving treatment for chronic hepatitis B with PEGASYS according to standard of care and in line with the current summary of product characteristics and local labeling who have no contraindication to PEGASYS therapy as per the local label. Target population are naïve subjects (who have never received any hepatitis B virus treatment) and previously treated subjects with nucleos(t)ide analogs (NAs).

Inclusion Criteria:

  • Male and female patients >/= 18 years of age
  • Hepatitis B virus e Antigen (HBeAg) positive or HBeAg negative serologically proven chronic hepatitis B (CHB) with or without cirrhosis (histologically verified at some point in the past)
  • Baseline hepatitis B virus (HBV) DNA >2,000 IU/ml
  • Elevated serum alanine aminotransferase (ALT) > Upper Limit of Normal (ULN)
  • Signed written informed consent
  • Patients treated with previous nucleos(t)ide analogs (NAs) therapy are eligible for this study

Exclusion Criteria:

  • Patients who have contraindications for peginterferon alfa-2a (PEGASYS®) in accordance with the approved summary of product characteristics (e.g., 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)
  • Patients with ALT > 10 x ULN or evidence of hepatocellular carcinoma
  • Patients with serological evidence of co-infection with hepatitis A virus, hepatitis C, human immunodeficiency virus or hepatitis D virus
  • Patients with decompensated liver disease
  • Pregnant or breast-feeding women
  • A history of liver transplantation or planned for liver transplantation
  • Concomitant therapy with telbivudine (concomitant peginterferon alfa-2a therapy is contraindicated according to telbivudine label)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02201407

Contact: Reference Study ID Number: ML29062 888-662-6728 (U.S. and Canada)

Belgrade, Serbia, 11000
Belgrade, Serbia, 11080
Kragujevac, Serbia, 34000
NIS, Serbia, 18000
Novi Sad, Serbia, 21000
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT02201407     History of Changes
Other Study ID Numbers: ML29062 
Study First Received: July 22, 2014
Last Updated: November 1, 2016
Health Authority: Serbia: Agency for Drugs and Medicinal Devices

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on December 09, 2016