An Open-Label Study to Evaluate Long-Term Results With Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir With or Without Ribavirin (RBV) on ovarian function in fertile women With Genotype 1 and 4 Chronic Hepatitis C Virus (HCV) Infection. - HCV_AMH_16

DIPARTIMENTO AD ATTIVITà INTEGRATA CHIRURGICO, MEDICO, ODONTOIATRICO E DI SCIENZE MORFOLOGICHE0 个研究点目标入组 50 人开始时间: 2021年6月8日最近更新: 2021年8月24日

研究概览

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•- Childbearing potential and sexually active with male partner(s) currently using at least one effective method of birth control at the time of screening and two effective methods of birth control while receiving study drugs, starting with Study Day 1 and for 7 months after stopping study drug.
•- Negative serum test within 24 hours prior to the start of investigational product.
•- Chronic HCV-infection prior to study enrollment
•- Screening laboratory result indicating HCV GT 1b or GT 1a or GT 4 infection.
•- Liver biopsy within 24 months prior to or during screening demonstrating a Metavir score of 2 or less or an Ishak score of 3 or less or Screening FibroScan® result of = 9.6 kPa;
•- Must be able to voluntarily sign and date an informed consent form.
•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 50
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Women who are pregnant or breastfeeding
•- Hypersensitivity to the active substance or to any of the excipients
•-Positive test result for HBsAg and HIV Ab
•-Recent history of drug or alcohol
•-History pf severe pre- existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six month
•- Presence of haemoglobinopathies
•- HCV genotype performed during screening indicates more than 1 subtype or co-infection with any other genotype.
•-Use of medications contraindicated
•-Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inducers of cytochrome P450 2C8 (CYP2C8) or strong inhibitors of CYP2C8
•-History of solid organ transplant.
•-Confirmed presence of hepatocellular carcinoma
•-Current use of any investigational or commercially available anti-HCV agents
•-Screening laboratory analyses showing any of the following abnormal laboratory results

发起方

DIPARTIMENTO AD ATTIVITà INTEGRATA CHIRURGICO, MEDICO, ODONTOIATRICO E DI SCIENZE MORFOLOGICHE