Hepatitis B Clinical Trial
Official title:
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.
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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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator)
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