End Stage Renal Disease Clinical Trial
Official title:
A Pilot Study to Treat Patients With Chronic HCV Genotype 1 and ESRD Receiving Hemodialysis and Naïve to Prior HCV Therapy With Peginterferon Alfa-2b, the Maximally Tolerated Ribavirin Dose and Boceprevir
1. A maximally tolerated dose of ribavirin can be defined in each patient with ESRD
undergoing hemodialysis.
2. Patients with Chronic Hepatitis C Virus (HCV)and End-Stage Renal Disease
(ESRD)undergoing hemodialysis will be able to tolerate and remain on treatment with
peginterferon alfa-2b, the maximally tolerated dose of ribavirin and boceprevir.
3. A significant percentage of patients with chronic HCV and ESRD undergoing hemodialysis
can achieve rapid virologic response (RVR), extended virologic response (eRVR) and
sustained virologic response (SVR) when treated with peginterferon alfa-2b, the
maximally tolerated dose of ribavirin and boceprevir.
Patients with ESRD will be treated with a dose escalation of ribavirin starting from 200 mg everyday (QD) to a maximal tolerated dose. Peginterferon will then be added. Ribavirin will be dose adjusted as needed. Boceprevir will then be added. Ribavirin will be dose adjusted as needed. Patients will be monitored for eRVR and SVR. The study end-point is eRVR. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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