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

Boceprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Difficult-to-Treat Menopausal Women With Chronic Hepatitis C Genotype 1, either deemed Nonresponders to Peginterferon/Ribavirin or treatment-naives. - MEN_BOC

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002459-33-IT

Enrollment

240

Registered

2011-09-21

Start date

2011-12-06

Completion date

Unknown

Last updated

2013-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

menopausal women with chronic HCV genotype1, naive or previously treated her with standard antiviral therapy MedDRA version: 14.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: vicrelis Pharmaceutical Form: Prolonged-release capsule INN or Proposed INN: Boceprevir CAS Number: 394730-60-0 Current Sponsor code: SCH503034 Concentration unit: mg milligram(s) Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: •For protocol (A), menopausal women with a null response (1.5 x upper limit of normal (ULN) •Serum albumin 1.2 x ULN or 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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): na;Timepoint(s) of evaluation of this end point: na	—

Countries

Italy

Contacts

Public ContactAnna Ferrari study coordinator

A.O.U. Policlinico di Modena - U.O. di Gastroenterologia

a.ferrari1102@gmail.com0594224023

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026