A Study of PEGASYS (Peginterferon Alfa-2a [40KD]) in Patients With Hepatitis B e Antigen (HBeAg)-Negative Chronic Hepatitis B Virus (HBV)

November 1, 2016 updated by: Hoffmann-La Roche

An Open-label, Multicenter, National, Not-randomized Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (40 KD) (PEGASYS) in Patients With HBeAg-negative Chronic Hepatitis B

This study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the target sample size is 60 individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

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
      • Plovdiv, Bulgaria, 4002
      • Sofia, Bulgaria, 1233
      • Sofia, Bulgaria, 1431
      • Sofia, Bulgaria, 1606
      • Sofia, Bulgaria, 1527
      • Sofia, Bulgaria, 1612
      • Stara Zagora, Bulgaria, 6000

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult participants 18-70 years of age
  • Positive test result for HBsAg for >6 months
  • Naive to treatment for HBV
  • On liver biopsy, liver disease consistent with chronic HBV, with or without compensated cirrhosis

Exclusion Criteria:

  • Co-infection with hepatitis A, C or D, or with Human Immunodeficiency Virus (HIV)
  • Decompensated liver disease
  • Hepatocellular cancer
  • Systemic anti-viral, anti-neoplastic, or immunomodulatory therapy less than or equal to 6 months before study drug
  • Medical condition associated with chronic liver disease

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peginterferon alfa-2a
Participants received 180 micrograms (uG) of Pegasys (0.5 milliliter [mL] solution) once a week subcutaneously for 48 weeks.
Drug: Peginterferon alfa-2a
180 uG in 0.5 mL solution administered once weekly for 48 weeks
Other Names:
  • Pegasys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy: Hepatitis B Virus - Deoxy ribonucleic acid (HBV-DNA) less than (<)20,000 Copies per milliliter (copies/mL) At End of Follow-Up
Time Frame: 72 Weeks
72 Weeks
Alanine Transaminase (ALT) Normalization at the End of Follow-Up
Time Frame: 72 Weeks
72 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy: Loss of Hepatitis B Virus Antigen ( HBsAg) and Seroconversion at End of Follow-Up
Time Frame: 72 Weeks
72 Weeks
Hepatitis B Virus (HBV) DNA Below the Limit of Quantification At the End of Follow-Up
Time Frame: 72 Weeks
72 Weeks
HBV DNA Suppression <20000 Copies/mL at the End of Treatment
Time Frame: 48 Weeks
48 Weeks
Alanine Transaminase (ALT) Normalization at the End of Treatment
Time Frame: 48 Weeks
48 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

November 1, 2004

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

October 5, 2015

First Submitted That Met QC Criteria

October 5, 2015

First Posted (Estimate)

October 7, 2015

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML18092

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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