Chronic Hepatitis C | Boceprevir/PegIFN α-2b/Riba in HCV+ Gt1 Menopausal Women, Nonresponders to PegIFN/Riba or Treatment-naives (MEN_BOC)
Chronic Hepatitis C research study
What is the primary objective of this study?
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).
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Chronic Hepatitis C
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Pegylated Interferon, Ribavirin, BoceprevirPEG IFN alfa 2b 1,5 ug/kg once weekly; Ribavirin (800-1400 mg / day) or PEG IFN alfa 2b 1,5 ug/kg once weekly; Ribavirin (800-1400 mg / day); Boceprevir (1.5 mcg / kg QW)
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
PEG IFN/RibavirinStandard of care for HCV-positive CAH
PEG IFN/Ribavirin/BoceprevirCombination to be tested for possible higher efficacy
Start Date: November 2011
Completed Date: June 2014
Phase: Phase 3
Primary Outcome: Improvement of sustained virological response in previous treatment failure or naive HCV-positive menopausal women.
Secondary Outcome: Early virological response
Study sponsors, principal investigator, and references
Principal Investigator: ERICA VILLA, Prof
Lead Sponsor: University of Modena and Reggio Emilia