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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by University of Modena and Reggio Emilia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Prof. Facchinetti Fabio, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier:
NCT01457937
First received: October 8, 2011
Last updated: September 29, 2012
Last verified: September 2012
  Purpose

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).


Condition Intervention Phase
Chronic Hepatitis C
Menopause
Drug: Pegylated Interferon, Ribavirin, Boceprevir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by University of Modena and Reggio Emilia:

Primary Outcome Measures:
  • Improvement of sustained virological response in previous treatment failure or naive HCV-positive menopausal women. [ Time Frame: Baseline and 72 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: Yes ]
    Evaluation of the percent of patients with early virological response (undetectable HCV RNA at weeks 2, 4, 8 or 12) that reach SVR


Estimated Enrollment: 240
Study Start Date: November 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PEG IFN/Ribavirin
Standard of care for HCV-positive CAH
Drug: Pegylated Interferon, Ribavirin, Boceprevir

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)

Other Names:
  • PEG IFN alfa 2b : Peg Intron
  • Ribavirin: Rebetol
  • Boceprevir: Victrelis
Experimental: PEG IFN/Ribavirin/Boceprevir
Combination to be tested for possible higher efficacy
Drug: Pegylated Interferon, Ribavirin, Boceprevir

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)

Other Names:
  • PEG IFN alfa 2b : Peg Intron
  • Ribavirin: Rebetol
  • Boceprevir: Victrelis

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01457937

Contacts
Contact: Erica Villa, Prof. +390594225308 erica.villa@unimore.it
Contact: Annalisa Berselli, B Sc +390594223045 annalisa.berselli@unimore.it

Locations
Italy
Gastroenterology Unit Recruiting
Modena, Italy, 41124
Contact: Erica Villa, Prof.    +390594225308    erica.villa@unimore.it   
Contact: Annalisa Bersellii, B Sc    +390594223045    annalisa.berselli@unimore.it   
Principal Investigator: Erica Villa, Prof.         
Sponsors and Collaborators
University of Modena and Reggio Emilia
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: ERICA VILLA, Prof Azienda Ospedaliero-Universitaria, University of Modena and Reggio Emilia
  More Information

No publications provided

Responsible Party: Prof. Facchinetti Fabio, Prs admin, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT01457937     History of Changes
Other Study ID Numbers: EudraCT 2011-002459-33
Study First Received: October 8, 2011
Last Updated: September 29, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Modena and Reggio Emilia:
HCV
Menopause
Peg IFN
Ribavirin
Boceprevir

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2b
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014