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

August 30, 2017 updated by: Hoffmann-La Roche

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Belgrade, Serbia, 11080
        • Clinical Center Zemun
      • Belgrade, Serbia, 11000
        • Clinic for gastroenterology and hepatology
      • Belgrade, Serbia, 11000
        • Clinical Center of Serbia; Institute For Infectious Diseases
      • Kragujevac, Serbia, 34000
        • Clinic for Infectious Diseases CC Kragujevac
      • NIS, Serbia, 18000
        • Clinic for Infectious Diseases CC Nis
      • Novi Sad, Serbia, 21000
        • Clinical Center Vojvodine; Clinic for Infectious Diseases; Clinic for Hematology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult participants receiving treatment for CHB with peginterferon alfa-2a according to standard of care and in line with the current summary of product characteristics and local labeling who have no contraindication to peginterferon alfa-2a therapy as per the local label. Target population are naïve participants (who have never received any HBV treatment) and previously treated participants with NAs.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
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.
Other Names:
  • PEGASYS

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2014

Primary Completion (Actual)

April 10, 2017

Study Completion (Actual)

April 10, 2017

Study Registration Dates

First Submitted

July 22, 2014

First Submitted That Met QC Criteria

July 24, 2014

First Posted (Estimate)

July 28, 2014

Study Record Updates

Last Update Posted (Actual)

August 31, 2017

Last Update Submitted That Met QC Criteria

August 30, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML29062

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis B, Chronic

Clinical Trials on Peginterferon alfa-2a

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe