A multicenter, randomized, open label, parallel-group phase IIB study on the efficacy and safety of oral regimens of DEB025 alone or in combination with ribavirin versus Standard of Care (peg-IFNa2a plus ribavirin) in treatment-naïve hepatitis C genotype 2 and 3 patients

ovartis Pharma Services AG0 个研究点目标入组 400 人开始时间: 2010年10月18日最近更新: 2012年10月9日

适应症

试验速览

暂无简介。

•Key inclusion criteria are:
•Written informed consent prior to any assessment;
•Males or females aged =18 and = 70 years;
•BMI between = 18 and = 36 kg/m2;
•Chronic hepatitis C virus infection;
•Serum HCV RNA = 10000 IU/ml; no upper limit;
•Infection with HCV genotypes 2 or 3;
•HCV treatment naïve;
•Female patients of child bearing potential must have a negative pregnancy test at screening and immediately prior to first administration of study drug.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Key exclusion criteria are:
•Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment, whichever is longer;
•Any contraindications to peg-IFNa2a and/or RBV treatment;
•Active or suspected cancer, or a history of malignancy where the risk of recurrence is = 20% within 2 years;
•HBsAg positive or HIV positive;
•Elevated (>ULN) total bilirubin level at screening.
•Gilbert’s disease.
•Cirrhosis, decompensated liver disease or complicated portal hypertension;
•Hepatocellular carcinoma;
•Pregnant, nursing or lactating women or women of child-bearing potential UNLESS they are using two birth control methods;
•Men whose female partners are pregnant or contemplating pregnancy. Fertile males UNLESS the patient and his partner agree to comply with acceptable contraception;
•Use of any other medication (including over the counter medication and herbal products) within 2 weeks before study start or within 5 drug half-lives of that medication (whichever is longer) that are known inhibitors/inducers of cytochrome 450 3A, substrates of cytochrome 450 3A, substrates of P-gp, or substrates/inhibitors of OATPs, MRP2 or BSEP;
•Any other cause of relevant liver disease other than HCV;
•History of moderate, severe, or uncontrolled psychiatric disease, especially depression.

发起方