Status:
UNKNOWN
Boceprevir/PegIFN α-2b/Riba in HCV+ Gt1 Menopausal Women, Nonresponders to PegIFN/Riba or Treatment-naives (MEN_BOC)
Lead Sponsor:
University of Modena and Reggio Emilia
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Chronic Hepatitis C
Menopause
Eligibility:
FEMALE
Phase:
PHASE3
Brief 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 ad...
Detailed Description
2.2.1 Hypothesis Our hypothesis is that the addition of a 24-week treatment with boceprevir to standard antiviral therapy with Peg IFN and ribavirin will increase the rate of sustained virological res...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2014
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01457937
Start Date
November 1 2011
End Date
June 1 2014
Last Update
October 2 2012
Active Locations (1)
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1
Gastroenterology Unit
Modena, Modena, Italy, 41124