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Study to Investigate Tolerability and Efficacy of MK5172 / MK8742 Without Ribavirin for 12 Weeks in Patients With Chronic HCV G1b Infection With Compensated Cirrhosis (GECOM)

Primary Purpose

Hepatitis C, Compensated Cirrhosis

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK5172 /MK8742
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Informed consent form signed,
  2. Age > 18 years,
  3. Chronic infection with Hepatitis C virus genotype 1b,
  4. HCV RNA > 100 IU/mL,
  5. HCV patients previously treated by PR with no response or previously treated with first generation PIs (boceprevir, telaprevir, simeprevir) and failing therapy,
  6. Subjects with compensated cirrhosis with Child-Pugh score ranging between A5 to A6. Cirrhosis defined by liver biopsy (METAVIR F4) or non-invasive methods (transient elastography (FibroScan) > 12.5 KPa; or FibroTest or FibroSure > 0.75 with APRI >2),
  7. Hepatic Venous Pressure Gradient (HVPG) > 6 mmHg (only in selected sites),
  8. Albumin level ≥ 3.0 g/dl,
  9. Platelet count ≥ 75 x 103/μL.

Exclusion Criteria:

  1. Child-Pugh score greater than CP-A6,
  2. Patients with HCV genotype 1a, 2, 3, 4, 5, 6,
  3. Have any serious or active medical illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance,
  4. HIV or chronic hepatitis B virus (HBV) infection (HBsAg positive),
  5. Decompensated cirrhosis/previous decompensation,
  6. Pregnancy,
  7. Breast-feeding,
  8. Known hypersensitivity to Grazoprevir, Elbasvir or any of its components,
  9. Albumin level < 3.0 g/dl,
  10. Platelet count < 75 x 103/μl,
  11. Concomitant participation in any clinical trial.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    MK5172 /MK8742

    Arm Description

    Outcomes

    Primary Outcome Measures

    Sustained virologic response rates 12 weeks after discontinuation of therapy (SVR12). SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 15, 2016
    Last Updated
    April 7, 2016
    Sponsor
    Istituto Clinico Humanitas
    Collaborators
    CD Pharma Group S.r.l.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02732405
    Brief Title
    Study to Investigate Tolerability and Efficacy of MK5172 / MK8742 Without Ribavirin for 12 Weeks in Patients With Chronic HCV G1b Infection With Compensated Cirrhosis
    Acronym
    GECOM
    Official Title
    A Multicenter, Open Label, Pilot Study to Investigate Tolerability and Efficacy of MK5172 / MK8742 Without Ribavirin for 12 Weeks in Patients With Chronic HCV G1b Infection With Compensated Cirrhosis (Child-Pugh A5 to A6) and No Response to PR or Prior Failure to First Generation Protease Inhibitors (PIs)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    March 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Istituto Clinico Humanitas
    Collaborators
    CD Pharma Group S.r.l.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To assess efficacy (SVR rate) of MK5172 / MK8742 for 12 weeks without RBV in G1b patients with compensated cirrhosis (Child-Pugh A5 to A6) previously failing first gen. PI or non responders to PR.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C, Compensated Cirrhosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MK5172 /MK8742
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    MK5172 /MK8742
    Intervention Description
    tablets of MK-5172 100 mg/MK-8742 50 mg will be administered orally, daily for 12 weeks without ribavirin
    Primary Outcome Measure Information:
    Title
    Sustained virologic response rates 12 weeks after discontinuation of therapy (SVR12). SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
    Time Frame
    12 weeks after discontinuation of therapy (SVR12).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Informed consent form signed, Age > 18 years, Chronic infection with Hepatitis C virus genotype 1b, HCV RNA > 100 IU/mL, HCV patients previously treated by PR with no response or previously treated with first generation PIs (boceprevir, telaprevir, simeprevir) and failing therapy, Subjects with compensated cirrhosis with Child-Pugh score ranging between A5 to A6. Cirrhosis defined by liver biopsy (METAVIR F4) or non-invasive methods (transient elastography (FibroScan) > 12.5 KPa; or FibroTest or FibroSure > 0.75 with APRI >2), Hepatic Venous Pressure Gradient (HVPG) > 6 mmHg (only in selected sites), Albumin level ≥ 3.0 g/dl, Platelet count ≥ 75 x 103/μL. Exclusion Criteria: Child-Pugh score greater than CP-A6, Patients with HCV genotype 1a, 2, 3, 4, 5, 6, Have any serious or active medical illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance, HIV or chronic hepatitis B virus (HBV) infection (HBsAg positive), Decompensated cirrhosis/previous decompensation, Pregnancy, Breast-feeding, Known hypersensitivity to Grazoprevir, Elbasvir or any of its components, Albumin level < 3.0 g/dl, Platelet count < 75 x 103/μl, Concomitant participation in any clinical trial.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Savino Bruno, MD
    Email
    savino.bruno@hunimed.eu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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