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

Hepatitis C Clinical Trial

— 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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02732405
• Other study ID #: 2015-004713-24
• 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

• Compensated Cirrhosis
• Hepatitis C
• Liver Cirrhosis

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