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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00114361
Recruitment Status : Completed
First Posted : June 15, 2005
Last Update Posted : June 22, 2010
Information provided by:
Foundation for Liver Research

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis B Drug: Ribavirin Drug: Peginterferon alpha 2a Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Official Title: Peginterferon Alfa-2a and Ribavirin Combination Therapy in Patients With HBeAg-negative Chronic HBV Infection (PARC Study)
Study Start Date : March 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : April 2010

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

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

Secondary Outcome Measures :
  1. ALT normalization [ Time Frame: May 2008 ]
  2. HBV DNA negativity(undetectable by Taqman PCR) [ Time Frame: May 2008 ]
  3. HBsAg loss from serum [ Time Frame: May 2008 ]
  4. Improvement liver histology [ Time Frame: May 2008 ]
  5. Combined virological, biochemical and histological response [ Time Frame: May 2008 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00114361

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Erasmus MC department hepatology
Rotterdam, Netherlands, 3000CA
Sponsors and Collaborators
Foundation for Liver Research
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Principal Investigator: Harry LA Janssen, MD PhD Foundation of Liver Research
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. H.L.A. Janssen, Foundation for Liver reseach Identifier: NCT00114361    
Other Study ID Numbers: HBV05-01
EudraCT: 2004-004736-30
First Posted: June 15, 2005    Key Record Dates
Last Update Posted: June 22, 2010
Last Verified: June 2010
Keywords provided by Foundation for Liver Research:
hepatitis B
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents