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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 10, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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