Chronic Hepatitis C MedDRA version: 14.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 100000004862
Conditions
Sponsors
MSD ITALIA S.R.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Each subject must be willing and able to provide written informed consent for the trial 2.Each subject must be aged between 18 and 75 years included 3.Each subject must weigh between 40 kg and 125 Kg 4.Each subject must have documented CHC genotype 1 infection. 5.Each subject must have underwent a previous course of treatment with standard of care (SOC: Peg-interferon alpha 2a or Peg-interferon alpha 2b + Ribavirin) with a documented non response. 6.Each subject must have a certified diagnosis of cirrhosis 7.Each subject must have an ultrasound within 6 months of the Screening Visit with no findings suspicious for hepatocellular carcinoma (HCC). 8.Each subject and each subject’s partner(s), childbearing potential, must agree to use 2 effective contraceptives as specified for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug (7 months for male subject). Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1.The subject has co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive) 2.The subject has used any investigational drugs within 30 days of the randomization visit in this study 3.The subject is participating in any other clinical trial within 30 days of randomization or has intention to participate in another clinical trial during participation in this study. 4.The subject has evidence of present or previous decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy. 5.The subject has clinically significant ocular examination findings 6.The subject has pre-existing significant psychiatric condition(s). 7.The subject has evidence of active or suspected malignancy, or a history of malignancy, within the last 3 years. Subjects under evaluation for malignancy are not eligible. 8.The subject has the following laboratory values: -Hb 1.5 x upper limit of normal (ULN).-Serum albumin ULN 10.Prothrombin time (PT) values >10% above laboratory reference range.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of boceprevir for 44 weeks, in addition to standard therapy in a cohort of patients with cirrhosis who have failed a previous course of appropriate treatment, defined as at least 12 weeks of therapy antiviral therapy with Peg-interferon and ribavirin;Secondary Objective: 1.safety of Boceprevir when used in combination with SOC in this subset of patients 2.to determine whether lead-in phase may i) better predict SVR in comparison to historical response and ii) identify predictors associated with SVR in poor responders (<1 log10 decay at TW4);Primary end point(s): The achievement of SVR, will be defined as undetectable HCV RNA at Follow-up Wk 24;Timepoint(s) of evaluation of this end point: See primary EP | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Is related to the safety of Boceprevir in addition to the Peg-Interferone and Ribavirin in patients with chronic hepatitis C and cirrhosis;Timepoint(s) of evaluation of this end point: See secondary EP | — |
Countries
Italy
Contacts
Public ContactDivisione Ricerca Clinica
MSD ITALIA S.R.L.
Outcome results
None listed