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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02732405
Other study ID # 2015-004713-24
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received March 15, 2016
Last updated April 7, 2016
Start date May 2016
Est. completion date March 2017

Study information

Verified date April 2016
Source Istituto Clinico Humanitas
Contact Savino Bruno, MD
Email savino.bruno@hunimed.eu
Is FDA regulated No
Health authority Italy: The Italian Medicines Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
MK5172 /MK8742
tablets of MK-5172 100 mg/MK-8742 50 mg will be administered orally, daily for 12 weeks without ribavirin

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Istituto Clinico Humanitas CD Pharma Group S.r.l.

Outcome

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
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