Effect of Boceprevir on HCV-specific T Cell Responses

CompletedOBSERVATIONAL
Enrollment

30

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

October 31, 2013

Conditions
Chronic Hepatitis C
Interventions
DRUG

Boceprevir

"In the experimental arm boceprevir (800 mg orally three times daily), PEG-IFN and ribavirin will be given for 24 weeks after the lead-in; the patients who will have undetectable HCV-RNA at week 8 will stop treatment at week 28; those who will be HCV-RNA positive at any visit between week 8 and 24 will receive an additional 20 weeks of PEG + RBV. Treatment will be discontinued if HCV-RNA is positive at week 24.~Immunological analysis will be performed longitudinally at the following time points: week -4, 0, 4 (end of lead-in), 8, 12, 24, 48, week 24 of follow-up. HCV-RNA will be quantified at the same time points and viremia will be correlated with immunological data."

Trial Locations (1)

43126

Unit of Infectious Diseases and Hepatology, Parma

All Listed Sponsors
lead

Azienda Ospedaliero-Universitaria di Parma

OTHER

NCT01403181 - Effect of Boceprevir on HCV-specific T Cell Responses | Biotech Hunter | Biotech Hunter