Chronic Hepatitis C Clinical Trial
Official title:
A Randomized, Open-lable, Multicenter, Parallel Group Study to Compare SVR Rate of Pegasys Plus Ribavirin for 48 Weeks vs. 36 Weeks in Patients With Chronic Hepatitis C
The purpose of this study is to evaluate the effect of PEGASYS® (peginterferon alfa-2a 40KD) plus Robatrol® (ribavirin) combination therapy given for 36 weeks versus 48 weeks on the clearance of HCV viremia 24 weeks after treatment end
Pegylated interferon plus ribavirin brings a good therapeutic response and curability.
However, the adverse effects and sufferings are lots. Response-guided, personalized
treatment is current principle. In patients of CHC, GT1 PR treatment for 24 weeks is
established in rapid virologic responders (RVR) who have low viral load before treatment. As
to patients with RVR but high viral load (HVL), the treatment duration is 48 weeks that is
the same as patients with complete early virologic response (cEVR). Is a shorter duration of
treatment feasible for those with a good virokinetic response? The ideal treatment duration
for patients of chronic hepatitis C, GT-1, high viral load with RVR has had no enough data
yet. Is it really necessary to double the treatment duration (48 weeks) for patients of
chronic hepatitis C, GT-1, high viral load with RVR? Is 36-week adequate for them? A
multicenter trial of INDIV-2 was presented at EASL 2010. They treated CHC patients of naïve
GT1 HVL and RVR for 30 weeks and got similarly good SVR as those treated for 48 weeks (85%
vs. 82%).
Therefore, investigators design a randomized controlled study to investigate the SVR rates
between treatment for 36 weeks and for 48 weeks in patients of CHC, GT1, HVL and RVR.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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