Genotype 1 and 4 Chronic Hepatitis C Virus (HCV) Infection MedDRA version: 20.1 Level: LLT Classification code 10047457 Term: Viral hepatitis C System Organ Class: 100000004862
Conditions
Interventions
Trade Name: VIEKIRAX - 12,5MG/75MG/50MG COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/PE/PCTFE/ALU) - 56 COMPRESSE (CONFEZIONE MULTIPLA)
Product Name: VIEKIRAX
Product Code: 043841
Pharmaceu
Sponsors
DIPARTIMENTO AD ATTIVITà INTEGRATA CHIRURGICO, MEDICO, ODONTOIATRICO E DI SCIENZE MORFOLOGICHE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluation of the AMH and estradiolo levels after successful antiviral therapy.;Timepoint(s) of evaluation of this end point: 84 weeks of follow up. | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The modification of AMH levels before and after successful antiviral therapy in comparison with age-matched HCV-positive women not undergoing antiviral treatment is the primary endpoint ;Secondary Objective: 1.Modification of AMH levels before and after successful antiviral therapy 2.Modification of the Estradiol (E2) levels 3.Percentage of participants experiencing miscarriage during 3 years observation post-therapy. ;Primary end point(s): Evaluation of the modification of AMH levels after successful antiviral therapy, during 48 weeks post treatment. ;Timepoint(s) of evaluation of this end point: 48 weeks post treatment | — |
Countries
Italy
Contacts
Public ContactUO GASTROENTEROLOGIA
DIPARTIMENTO AD ATTIVIT¿ INTEGRATA CHIRURGICO, MEDICO, ODONTOIATRICO E DI SCIENZE MORFOLOGICHE
Outcome results
None listed