- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02732405
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)
April 7, 2016 updated by: Istituto Clinico Humanitas
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)
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Savino Bruno, MD
- Email: savino.bruno@hunimed.eu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MK5172 /MK8742
|
tablets of MK-5172 100 mg/MK-8742 50 mg will be administered orally, daily for 12 weeks without ribavirin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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).
|
12 weeks after discontinuation of therapy (SVR12).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
March 1, 2017
Study Registration Dates
First Submitted
March 15, 2016
First Submitted That Met QC Criteria
April 7, 2016
First Posted (Estimate)
April 8, 2016
Study Record Updates
Last Update Posted (Estimate)
April 8, 2016
Last Update Submitted That Met QC Criteria
April 7, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-004713-24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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