48 Weeks Combination Therapy for Patients With HBeAg-negative Chronic Hepatitis B Virus (HBV) Infection
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
|Official Title:||Peginterferon Alfa-2a and Ribavirin Combination Therapy in Patients With HBeAg-negative Chronic HBV Infection (PARC Study)|
- The combined presence of HBV DNA level < 10E4 copies/ml and ALT normalization at the end of follow-up [ Time Frame: may 2008 ] [ Designated as safety issue: No ]
- ALT normalization [ Time Frame: May 2008 ] [ Designated as safety issue: No ]
- HBV DNA negativity(undetectable by Taqman PCR) [ Time Frame: May 2008 ] [ Designated as safety issue: No ]
- HBsAg loss from serum [ Time Frame: May 2008 ] [ Designated as safety issue: No ]
- Improvement liver histology [ Time Frame: May 2008 ] [ Designated as safety issue: No ]
- Combined virological, biochemical and histological response [ Time Frame: May 2008 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2005|
|Study Completion Date:||April 2010|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Ribavirin + Peg IFN
1200 mg a day, 48 weeks
Active Comparator: 2
Peg IFN + Placebo
Drug: Peginterferon alpha 2a
180 µg per week, 48 weeks
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.
|Erasmus MC department hepatology|
|Rotterdam, Netherlands, 3000CA|
|Principal Investigator:||Harry LA Janssen, MD PhD||Foundation of Liver Research|