48 Weeks Combination Therapy for Patients With HBeAg-negative Chronic Hepatitis B Virus (HBV) Infection

June 18, 2010 updated by: Foundation for Liver Research

Peginterferon Alfa-2a and Ribavirin Combination Therapy in Patients With HBeAg-negative Chronic HBV Infection (PARC Study)

The purpose of this study is to investigate whether in patients with chronic HBeAg-negative hepatitis B, PEG-IFN-ribavirin combination therapy for 1 year leads to enhanced response (HBV DNA <10E4 copies/ml and normal ALT 24 weeks after treatment discontinuation) in comparison with pegylated interferon (PEG-IFN) monotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite the introduction of newer drugs for the treatment of chronic hepatitis B, there is still no optimal treatment. Pegylated interferon alfa has proven sustained efficacy in approximately 30-40% of patients with HBeAg-positive or HBeAg-negative chronic hepatitis B. It is likely that combination therapy of pegylated interferon alfa with ribavirin in chronic hepatitis B is more effective than pegylated interferon alfa monotherapy. In chronic hepatitis C, adding ribavirin to pegylated interferon therapy doubled the sustained response rate (29% vs. 56%) and has become the standard option of treatment.

To investigate the effect of the treatment with pegylated interferon and ribavirin on the amount of inflammation and fibrosis in the liver, a liver biopsy will be performed within one year prior to screening and at the end of follow-up.

When patients with chronic hepatitis B are treated outside any study with pegylated interferon, they visit the outpatient clinic approximately every month for blood samples. So in this study the amount of blood samples taken from every patient is not increased as compared with treatment outside a study.

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 3

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

  • Netherlands
      • Rotterdam, Netherlands, 3000CA
        • Erasmus MC department hepatology

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:

  • Chronic hepatitis B
  • Biopsy performed within one year prior to screening or during screening
  • ALT > 1.5 x ULN
  • HBeAg negative, anti-HBeAg positive
  • HBV DNA > 10E5 copies/ml
  • Age 18-70 years
  • Written informed consent
  • Hepatic imaging without evidence of HCC
  • All fertile males and females must be using two forms of effective contraception

Exclusion Criteria:

  • Antiviral therapy against HBV within the previous 6 months; treatment with any investigational drug within 30 days of entry to this protocol
  • Severe hepatitis activity as documented by ALT > 10 x ULN
  • Advanced liver disease
  • Pre-existent leucopenia or thrombopenia
  • Co-infection with HCV,HDV or HIV
  • Other acquired or inherited causes of liver disease
  • Alpha fetoprotein > 50 ng/ml.
  • Evidence of severe renal disease
  • Hyper- or hypothyroidism
  • Significant cardiovascular or pulmonary dysfunction, malignancy,immunodeficiency syndromes
  • Immune suppressive treatment within the previous 6 months
  • Contra-indications for alpha-interferon therapy
  • Pregnancy, breast-feeding
  • Any medical condition requiring chronic systemic administration of steroids
  • Substance alcohol or drug abuse
  • Subjects with clinically significant retinal abnormalities
  • Subjects with clinically significant hearing abnormalities
  • Hemoglobinopathies
  • Subjects with known hypersensitivity to ribavirin

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

  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Ribavirin + Peg IFN
Drug: Ribavirin
1200 mg a day, 48 weeks
Active Comparator: 2
Peg IFN + Placebo
Drug: Peginterferon alpha 2a
180 µg per week, 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The combined presence of HBV DNA level < 10E4 copies/ml and ALT normalization at the end of follow-up
Time Frame: may 2008
may 2008

Secondary Outcome Measures

Outcome Measure
Time Frame
ALT normalization
Time Frame: May 2008
May 2008
HBV DNA negativity(undetectable by Taqman PCR)
Time Frame: May 2008
May 2008
HBsAg loss from serum
Time Frame: May 2008
May 2008
Improvement liver histology
Time Frame: May 2008
May 2008
Combined virological, biochemical and histological response
Time Frame: May 2008
May 2008

Collaborators and Investigators

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

Sponsor

Foundation for Liver Research

Investigators

  • Principal Investigator: Harry LA Janssen, MD PhD, Foundation of Liver Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2005

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

June 14, 2005

First Submitted That Met QC Criteria

June 14, 2005

First Posted (Estimate)

June 15, 2005

Study Record Updates

Last Update Posted (Estimate)

June 22, 2010

Last Update Submitted That Met QC Criteria

June 18, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBV05-01
  • EudraCT: 2004-004736-30

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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