Evaluating the effectiveness of therapy whith Boceprevir associated with antiviral therapy standard for chronic hepatitis viruc HCV in a population of menopausal women ganotipe one ever treated or not responsive to previous treatment

Active, not recruiting

• Conditions: menopausal women with chronic HCV genotype1, naive or previously treated her with standard antiviral therapy; MedDRA version: 14.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-002459-33-IT
• Lead Sponsor: AZIENDA OSPEDALIERA POLICLINICO DI MODENA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-21
• Last Update Posted: 1 April 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

• Menopausal females with previously documented CHC infection, either (A) relapser or with a >2log10 IU/ml HCV RNA decrease at week 12 in a previous PEG IFN/Ribavirin treatment or (B) naives; • Subject must have a liver biopsy within the last 2 years with histology consistent with CHC and no other etiology. • Subjects with bridging fibrosis or cirrhosis must have an ultrasound within 6 months of the Screening Visit (or between Screening and Day 1) with no findings suspicious for hepatocellular carcinoma (HCC).
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 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

•For protocol (A), menopausal women with a null response (<2log10 IU/ml HCV RNA decrease at week 12) in a previous PEG IFN/Ribavirin treatment. •Coinfection with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive). •Treatment with any investigational drug within 30 days of the randomization visit in this study. •Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial during participation in this study. •Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy. •Diabetic and/or hypertensive subjects with clinically significant ocular examination findings: retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or any other clinically significant abnormality. •Pre-existing psychiatric condition(s). •Clinical diagnosis of substance abuse of the specified drugs within the specified timeframes. •Any known pre-existing medical condition that could interfere with the subject's participation in and completion of the study. •Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin). Subjects under evaluation for malignancy are not eligible. •Subjects who had life-threatening serious adverse event (SAE) during screening period. •Protocol-specified hematologic, biochemical, and serologic criteria: Hemoglobin <12 g/dL for females and <13 g/dL for males; Neutrophils <1500/mm^3 (blacks: <1200/mm^3); Platelets <100,000/mm^3; Direct bilirubin >1.5 x upper limit of normal (ULN) •Serum albumin < lower limit of normal (LLN) •Thyroid-stimulating hormone (TSH) >1.2 x ULN or <0.8 x LLN of laboratory, with certain exceptions. •Serum creatinine >ULN of the laboratory reference. •Protocol-specified serum glucose concentrations. •Prothrombin time/partial thromboplastin time (PT/PTT) values >10% above laboratory reference range. •Anti-nuclear antibodies (ANA) >1:320.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To verify whether the addition of Boceprevir 800 mg TID to standard antiviral therapy with PEG IFN alfa 2b (1.5 µg/kg QW) plus Ribavirin (800-1400 mg/day) will determine at least a 25% improvement in SVR in the cohort of difficult-to-treat post-menopausal women with chronic hepatitis C (CHC) genotype 1 (either previous nonresponders to Peginterferon/Ribavirin (RBV) treatment or treatment naïves).;Secondary Objective: na;Primary end point(s): To verify whether the addition of Boceprevir 800 mg TID to standard antiviral therapy with PEG IFN alfa 2b (1.5 µg/kg QW) plus Ribavirin (800-1400 mg/day) will determine at least a 25% improvement in SVR in the cohort of difficult-to-treat post-menopausal women with chronic hepatitis C (CHC) genotype 1 (either previous nonresponders to Peginterferon/Ribavirin (RBV) treatment or treatment naïves).;Timepoint(s) of evaluation of this end point: 72 week

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): na;Timepoint(s) of evaluation of this end point: na