EUCTR2015-004713-24-IT
Active, not recruiting
Phase 1
A Multicenter, Open Label, Pilot Study to Investigate Tolerability and Efficacy of MK5172 (Grazoprevir) / MK8742 (Elbasvir) 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).GECOM study - GECOM Study
IRCCS ISTITUTO CLINICO HUMANITAS0 sites120 target enrollmentNovember 30, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- IRCCS ISTITUTO CLINICO HUMANITAS
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 (transientelastography (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.
- •Are the trial subjects under 18? no
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/?l,
Outcomes
Primary Outcomes
Not specified
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