Boceprevir/PegIFN α-2b/Riba in HCV+ Gt1 Menopausal Women, Nonresponders to PegIFN/Riba or Treatment-naives (MEN_BOC)

• Status: Unknown status
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The cohort of post-menopausal women represents a group of very-difficult-to-treat patients in whom a more powerful approach is required in order to improve the disappointing response rate. Thus the addition, in patients with previous failure to PEG/RBV treatment or in naïve patients, of a powerful drug like Boceprevir could greatly improve SVR rate as suggested by the results of SPRINT_2 trial in whom Boceprevir addition determined a 30% improvement in SVR rate in difficult gt 1 patients of African descent versus standard PEG IFN/Ribavirin therapy or by those of RESPOND-2 that showed the same percent improvement of RGT-retreatment with Boc/P/R of previous failure of standard therapy.

Goal of the study is to verify whether the addition of a 24-week treatment with boceprevir to standard antiviral therapy with Peg IFN and ribavirin will increase the rate of SVR in patients difficult to treat, such as HCV-positive women in post-menopausal women with genotype 1, not only those who have never been treated, but also in those who have not responded to previous treatment with peginterferon and ribavirin (Riba).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Modena and Reggio Emilia
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Interferon-alpha; Interferons; Peginterferon alfa-2b; Ribavirin

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).

• Subject must be willing to give written informed consent.

Exclusion Criteria:

• 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.