Hepatitis C Clinical Trial
— GECOMOfficial 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)
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.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | March 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Istituto Clinico Humanitas | CD Pharma Group S.r.l. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 12 weeks after discontinuation of therapy (SVR12). | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
Recruiting |
NCT04510246 -
Link Hepatitis C Notifications to Treatment in Tasmania
|
N/A | |
Completed |
NCT03413696 -
Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
|
||
Completed |
NCT03118674 -
Harvoni Treatment Porphyria Cutanea Tarda
|
Phase 2 | |
Completed |
NCT03109457 -
Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma
|
||
Completed |
NCT01458054 -
Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults
|
Phase 1 | |
Completed |
NCT03740230 -
An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs
|
||
Completed |
NCT03426787 -
Helping Empower Liver and Kidney Patients
|
N/A | |
Completed |
NCT03627299 -
Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors
|
Phase 4 | |
Completed |
NCT00006301 -
Immune Response to Hepatitis C Virus
|
||
Active, not recruiting |
NCT03949764 -
The Kentucky Viral Hepatitis Treatment Study
|
Phase 4 | |
Completed |
NCT03365635 -
Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C
|
Phase 4 | |
Recruiting |
NCT04405024 -
Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients
|
N/A | |
Completed |
NCT04525690 -
Improving Inpatient Screening for Hepatitis C
|
N/A | |
Completed |
NCT04033887 -
Evaluation Study of RDTs Detecting Antibodies Against HCV
|
||
Withdrawn |
NCT04546802 -
HepATocellular Cancer Hcv Therapy Study
|
Phase 3 | |
Active, not recruiting |
NCT02961426 -
Strategic Transformation of the Market of HCV Treatments
|
Phase 2/Phase 3 | |
Completed |
NCT02869776 -
Integrating HCV and HIV Screening During the Era of HIV Antigen Testing
|
N/A | |
Completed |
NCT02683005 -
Study of Hepatitis C Treatment During Pregnancy
|
Phase 1 | |
Completed |
NCT03186313 -
A Study to Evaluate the Safety and Efficacy of the Combined Single Dose of Dactavira Plus Or Dactavira in Egyptian Adults With Chronic Genotype 4 HCV Infection
|
Phase 3 |