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

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ClinicalTrials.gov Identifier: NCT00114361
Recruitment Status : Completed
First Posted : June 15, 2005
Last Update Posted : June 22, 2010
Sponsor:
Information provided by:
Foundation for Liver Research

Tracking Information
First Submitted Date  ICMJE June 14, 2005
First Posted Date  ICMJE June 15, 2005
Last Update Posted Date June 22, 2010
Study Start Date  ICMJE March 2005
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2008)
The combined presence of HBV DNA level < 10E4 copies/ml and ALT normalization at the end of follow-up [ Time Frame: may 2008 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
The combined presence of HBV DNA level < 104 copies/ml and ALT normalization at the end of follow-up
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2008)
  • ALT normalization [ Time Frame: May 2008 ]
  • HBV DNA negativity(undetectable by Taqman PCR) [ Time Frame: May 2008 ]
  • HBsAg loss from serum [ Time Frame: May 2008 ]
  • Improvement liver histology [ Time Frame: May 2008 ]
  • Combined virological, biochemical and histological response [ Time Frame: May 2008 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • 1. ALT normalization
  • 2. HBV DNA negativity(undetectable by Taqman PCR)
  • 3. HBsAg loss from serum
  • 4. Improvement liver histology
  • 5. Combined virological, biochemical and histological response
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 48 Weeks Combination Therapy for Patients With HBeAg-negative Chronic Hepatitis B Virus (HBV) Infection
Official Title  ICMJE Peginterferon Alfa-2a and Ribavirin Combination Therapy in Patients With HBeAg-negative Chronic HBV Infection (PARC Study)
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Hepatitis B
Intervention  ICMJE
  • Drug: Ribavirin
    1200 mg a day, 48 weeks
  • Drug: Peginterferon alpha 2a
    180 µg per week, 48 weeks
Study Arms  ICMJE
  • Active Comparator: 1
    Ribavirin + Peg IFN
    Intervention: Drug: Ribavirin
  • Active Comparator: 2
    Peg IFN + Placebo
    Intervention: Drug: Peginterferon alpha 2a
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2008)
138
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
122
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00114361
Other Study ID Numbers  ICMJE HBV05-01
EudraCT: 2004-004736-30
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. H.L.A. Janssen, Foundation for Liver reseach
Study Sponsor  ICMJE Foundation for Liver Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Harry LA Janssen, MD PhD Foundation of Liver Research
PRS Account Foundation for Liver Research
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP