Hepatitis C Clinical Trial
Official title:
Does Induction PEG-Intron in Combination With Rebetol Enhance the Sustained Response Rates in Patients With Chronic Hepatitis C
The purpose of this study is to see which of two doses of PEG (polyethylene glycol)
interferon alfa-2b in combination with Ribavirin for 48 weeks is more effective at
elimination of hepatitis C.
The primary objective of this study is to compare the efficacy of Induction PEG-Interferon
alfa-2b (PEG-Intron) and Ribavirin (Rebetol) to standard PEG-Interferon alfa-2b (PEG-Intron)
and Ribavirin (Rebetol) in patients with chronic hepatitis C.
The purpose of this study is to determine if the use of induction dose PEG-Intron in
combination with Rebetol will enhance the elimination of Hepatitis C in treatment naïve
patients with genotype 1 and 4.
Currently PEG-Interferon alfa-2b plus Ribavirin results in a sustained response in 54-61% of
patients with Hepatitis C. Those with genotype 1and 4 and high viral loads are the most
likely to have a less favorable response. The administration of induction dose interferon in
combination with Ribavirin may yield an improved sustained response rate in these more
difficult to treat patients with chronic Hepatitis C.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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