HCV-1 with insulin resistance MedDRA version: 14.1 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
MSD ITALIA S.R.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Each subject must have >= 18 years of age. 2.Each subject must have quantifiable serum HCV-RNA 3.Each subject must have infection with HCV-1 4.Each subject must have HOMA IR > 2.5 in two determinations made 4 weeks apart 5.Each subject must have previous failure to achieve SVR with PEG-IFN plus Ribavirin given for a minimum of 12 weeks without dose reduction below 80% of the adequate doses of the two drugs. 6.Each subject must be with no/partial response or relapser 7.Each subject must have compensated liver disease with or without histologic or non-invasive evidence of liver cirrhosis 8.Each subject must have no contraindications to PEG-IFN or to Ribavirin as defined in the labels of the drugs to be used in combination with Boceprevir 9.If heterosexually active, a female subject of childbearing potential and a non vasectomized male subject who has a female partner of childbearing potential must agree to use 2 effective contraceptives until 6 months after therapy has ended (7 months for male subject) 10.Each subject must be able to adhere to dose and visit schedules 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 50
Exclusion criteria
Exclusion criteria: 1.Subject with coinfection with HCV genotypes other than HCV-1 2.Subject with Evidence of decompensated liver disease 3.Subject with history of ascites, hepatic encephalopathy or of bleeding varices or of severe portal hypertension 4.Subject with history or signs or symptoms or evidence of HCC. 5.Subject with other important comorbidities (Cardiovascular diseases, Type 1 diabetes or indaquately controlled type 2 diabetes, malignancies , etc) 6.Subject with Haemoglobin 20 gr/day for females and > 30 gr/day for males 15.Subject with hypersensitivity or any other contraindication to PEG-IFN or RIBAVIRIN or to any component of the Boceprevir formulation 16.Subject with evidence of severe adverse events during previous treatment with PEG-IFN plus RIBAVIRIN, including discontinuation of therapy for severe anemia or haematologic toxicity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Sustained Virological Response (24w SVR) with a triple combination therapy consisting of PEG-IFN plus Ribavirin Plus Boceprevir in “ difficult to retreat HCV-1 patients” who have failed previous treatment with PEG-IFN and Ribavirin and have insulin resistance at baseline. SVR will be defined as undetectable serum HCV-RNA 24 weeks after cessation of antiviral therapy; Secondary Objective: 1.assessment of the evolution and selection of Boceprevir resistant variants during retreatment with triple therapy in HCV-1 infected patients with baseline insulin resistance, 2.assessment of the effect of several variables, including baseline HOMA-IR levels, BMI, liver disease stage and the pattern of previous response to dual PEG-IFN plus Ribavirin therapy, on early and SVR to retreatment with triple therapy, 3.assessment of the effect of insulin resistance at baseline on the virological response during the 4 week lead-in phase and at week 8 after adding Boceprevir ;Primary end point(s): The achievement of Sustained Virological Response (24w SVR) defined as undetectable serum HCV-RNA 24 weeks after cessation of antiviral therapy;Timepoint(s) of evaluation of this end point: Raggiungimento di risposta virologica sostenuta (SVR) definita come non rilevabilità dell’HCV-RNA plasmatico alla settimana 24 di follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Analysis of Boceprevir resistance variants 2.Changes in HOMA-IR ; Timepoint(s) of evaluation of this end point: 1.Baseline, week 4, weekly while treated with Boceprevir, monthly after stopping Boceprevir, at end of therapy, every 3 months after stopping therapy 2.At baseline and at different timepoints during and after therapy | — |
Countries
Italy
Contacts
Public ContactDivisione Ricerca Clinica
MSD Italia srl
Outcome results
None listed