An open label study assessing SVR and Viral Resistance profile with Boceprevir plus PEG-IFN plus Ribavirin triple therapy in HCV-1 infected patients with insulin resistance who have failed PEG-IFN plus Ribavirin dual therapy

MSD ITALIA S.R.L.0 个研究点目标入组 100 人开始时间: 2012年12月28日最近更新: 2019年11月25日

试验速览

暂无简介。

•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

•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 < 12 g/dL for females and < 13 g/dL for males
•7.Subject with Neutrophils < 1500 mm3
•8.Subject with Platelets < 100000 mm3
•9.Subject with organ transplant
•10.Subject with coinfection with HBV or HIV
•11.Subject with severe psychiatric disease
•12.Subject with inadequately controlled thyroid function
•13.Subject with substances abuse
•14.Subject with alcohol intake > 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.

发起方

MSD ITALIA S.R.L.