An Observational Study of Peginterferon Alfa-2a (PEGASYS®) in Patients With HBeAg Positive or HBeAg Negative Chronic Hepatitis B

March 10, 2017 updated by: Hoffmann-La Roche

A Multicenter, Prospective, Observational, Non-interventional Study Evaluating On-treatment Predictors of Response in Subjects With HBeAg Positive or HBeAg Negative Chronic Hepatitis B Receiving Therapy With PEGASYS® (Peginterferon Alfa-2a 40KD)

This prospective, multicenter, observational study will evaluate on-treatment predictors of response in patients with HBeAg positive or HBeAg negative chronic hepatitis B receiving treatment with peginterferon alfa-2a (PEGASYS®) in accordance with local labeling and the summary of product characteristics. Data will be collected from patients for the duration of their treatment and for up to 24 weeks thereafter.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

141

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

  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Mhat - Pleven; Clinic of Gastroenterology
      • Plovdiv, Bulgaria, 4002
        • Umhat St. Georgi; Clinical of Gastroenterology
      • Sofia, Bulgaria, 1407
        • MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases
      • Sofia, Bulgaria, 1431
        • UMHAT Alexandrovska EAD; Gastroenterology
      • Sofia, Bulgaria, 1527
        • Mhat Queenjoanna; Clinic of Gastroenterology
      • Sofia, Bulgaria, 1606
        • Military Medical Academy; Gastroenterology
      • Sofia, Bulgaria, 1612
        • Mhat St. Ivan Rilski; Clinic of Gastroenterology
      • Stara Zagora, Bulgaria, 6000
        • Mhat St. Zagora; Clinical of Gastroenterology
      • Varna, Bulgaria, 9010
        • Mhat Sveta Marina; Clinic of Gastroenterology

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

Probability Sample

Study Population

Patients with chronic hepatitis B on treatment with PEGASYS.

Description

Inclusion Criteria:

  • Adult patients ≥ 18 years of age.
  • Hepatitis B envelope antigen (HBeAg) positive or HBeAg negative hepatitis B with or without cirrhosis.
  • Elevated alanine aminotransferase (ALT) > upper limit of normal (ULN) but ≤ 10 x ULN according to local label.

Exclusion Criteria:

  • Contraindications to peginterferon alfa-2a (PEGASYS®) as detailed in the label.
  • Co-infection with hepatitis A, hepatitis C, or human immunodeficiency virus (HIV).
  • Concomitant treatment with telbivudine.
  • Pregnant or lactating women.

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
Peginterferon alfa-2a
Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
Biological: Peginterferon alfa-2a
Peginterferon alfa-2a commercial product (PEGASYS®) was supplied as a solution in prefilled syringes.
Other Names:
  • PEGASYS®
  • RO0258310

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study
Time Frame: At the end of the study (Week 36)
Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml).
At the end of the study (Week 36)
Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml
Time Frame: approximately 3 years
approximately 3 years
In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive
Time Frame: approximately 3 years
approximately 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment
Time Frame: At the end of treatment (Week 24)
Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml) separately for participants who were hepatitis B envelope antigen (HBeAg) positive and HBeAg negative.
At the end of treatment (Week 24)
HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative
Time Frame: approximately 3 years
approximately 3 years
Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients
Time Frame: approximately 3 years
approximately 3 years
Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients
Time Frame: approximately 3 years
approximately 3 years
Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio
Time Frame: approximately 3 years
approximately 3 years
Safety: Incidence of Adverse Events
Time Frame: approximately 3 years
approximately 3 years

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)

July 8, 2011

Primary Completion (Actual)

August 12, 2014

Study Completion (Actual)

August 12, 2014

Study Registration Dates

First Submitted

August 15, 2012

First Submitted That Met QC Criteria

August 15, 2012

First Posted (Estimate)

August 17, 2012

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

March 10, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML25626

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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