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

Primary Purpose

Chronic Hepatitis C, Menopause

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Pegylated Interferon, Ribavirin, Boceprevir
Sponsored by
University of Modena and Reggio Emilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring HCV, Menopause, Peg IFN, Ribavirin, Boceprevir

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Gastroenterology UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PEG IFN/Ribavirin

PEG IFN/Ribavirin/Boceprevir

Arm Description

Standard of care for HCV-positive CAH

Combination to be tested for possible higher efficacy

Outcomes

Primary Outcome Measures

Improvement of sustained virological response in previous treatment failure or naive HCV-positive menopausal women.
Verify whether the SVR (HCV RNA undetectable at 24 wks) in menopausal women with HCV CAH genotype 1 with a previous failure with PEG IFN/ribavirin or treatmenti-naive may increase by 20% or 25% respectively after treatment with PEG IFN alfa 2b and boceprevir (1.5 mcg / kg QW) + Ribavirin (800-1400 mg / day).

Secondary Outcome Measures

Early virological response
Evaluation of the percent of patients with early virological response (undetectable HCV RNA at weeks 2, 4, 8 or 12) that reach SVR

Full Information

First Posted
October 8, 2011
Last Updated
September 29, 2012
Sponsor
University of Modena and Reggio Emilia
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01457937
Brief Title
Boceprevir/PegIFN α-2b/Riba in HCV+ Gt1 Menopausal Women, Nonresponders to PegIFN/Riba or Treatment-naives (MEN_BOC)
Acronym
MEN_BOC
Official Title
Boceprevir/Peginterferon Alfa (PegIFN α)-2b/Ribavirin (Riba) in Difficult-to-Treat Menopausal Women With Chronic Hepatitis C Genotype 1 (Gt 1), Either Deemed Nonresponders to Peginterferon/Ribavirin or Treatment-naives (MEN_BOC)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Modena and Reggio Emilia
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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).
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 response (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) Objectives Retreatment Primary objective Verify whether the sustained virological response (SVR defined as HCV RNA undetectable at 24 weeks of follow-up) in menopausal women with HCV CAH genotype 1 who have not achieved a sustained virological response with a previous treatment with PEG IFN/ribavirin may increase by at least 20% after treatment with PEG IFN alfa 2b and boceprevir (1.5 mcg / kg QW) + Ribavirin (800-1400 mg / day) The primary efficacy endpoint, achieving SVR, will be evaluated with descriptive statistics (n,%) for each treatment arm. Secondary objective It is represented by evaluation of the percent of patients with early virological response (undetectable HCV RNA at weeks 2, 4, 8 or 12) that reach SVR. Naïve patients Primary objective Verify whether SVR, defined as undetectable HCV-RNA at 24 weeks of follow-up may increase by at least 25% after treatment with PEG IFN alfa 2b plus ribavirin and boceprevir vs. PEG IFN alfa 2b plus ribavirin alone, in postmenopausal women with CHC genotype 1 not previously treated The primary efficacy endpoint, achieving SVR, will be evaluated with descriptive statistics (n,%) for each treatment arm. Secondary objective It is represented by evaluation of the percent of patients with early virological response (undetectable HCV RNA at weeks 2, 4, 8 or 12) that reach SVR.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C, Menopause
Keywords
HCV, Menopause, Peg IFN, Ribavirin, Boceprevir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PEG IFN/Ribavirin
Arm Type
Active Comparator
Arm Description
Standard of care for HCV-positive CAH
Arm Title
PEG IFN/Ribavirin/Boceprevir
Arm Type
Experimental
Arm Description
Combination to be tested for possible higher efficacy
Intervention Type
Drug
Intervention Name(s)
Pegylated Interferon, Ribavirin, Boceprevir
Other Intervention Name(s)
PEG IFN alfa 2b : Peg Intron, Ribavirin: Rebetol, Boceprevir: Victrelis
Intervention Description
PEG 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)
Primary Outcome Measure Information:
Title
Improvement of sustained virological response in previous treatment failure or naive HCV-positive menopausal women.
Description
Verify whether the SVR (HCV RNA undetectable at 24 wks) in menopausal women with HCV CAH genotype 1 with a previous failure with PEG IFN/ribavirin or treatmenti-naive may increase by 20% or 25% respectively after treatment with PEG IFN alfa 2b and boceprevir (1.5 mcg / kg QW) + Ribavirin (800-1400 mg / day).
Time Frame
Baseline and 72 weeks
Secondary Outcome Measure Information:
Title
Early virological response
Description
Evaluation of the percent of patients with early virological response (undetectable HCV RNA at weeks 2, 4, 8 or 12) that reach SVR
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erica Villa, Prof.
Phone
+390594225308
Email
erica.villa@unimore.it
First Name & Middle Initial & Last Name or Official Title & Degree
Annalisa Berselli, B Sc
Phone
+390594223045
Email
annalisa.berselli@unimore.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ERICA VILLA, Prof
Organizational Affiliation
Azienda Ospedaliero-Universitaria, University of Modena and Reggio Emilia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastroenterology Unit
City
Modena
ZIP/Postal Code
41124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erica Villa, Prof.
Phone
+390594225308
Email
erica.villa@unimore.it
First Name & Middle Initial & Last Name & Degree
Annalisa Bersellii, B Sc
Phone
+390594223045
Email
annalisa.berselli@unimore.it
First Name & Middle Initial & Last Name & Degree
Erica Villa, Prof.

12. IPD Sharing Statement

Citations:
PubMed Identifier
25469044
Citation
Bernabucci V, Ciancio A, Petta S, Karampatou A, Turco L, Strona S, Critelli R, Todesca P, Cerami C, Sagnelli C, Rizzetto M, Camma C, Villa E. Boceprevir is highly effective in treatment-experienced hepatitis C virus-positive genotype-1 menopausal women. World J Gastroenterol. 2014 Nov 28;20(44):16726-33. doi: 10.3748/wjg.v20.i44.16726.
Results Reference
derived

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

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