CClinicalTrials.gg
Sign In
Status unknownNCT02732405GECOMUpdated Apr 8, 2016

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

A Phase 3 interventional study of MK5172 /MK8742 in Hepatitis C and Compensated Cirrhosis, sponsored by Istituto Clinico Humanitas. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-08.

Sponsored by Istituto Clinico Humanitas · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatitis C
  • Compensated Cirrhosis
03

In context

Hepatitis C

2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.

This study's planned enrollment of 120 is above the median of 79 across 1,633 interventional studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

Istituto Clinico Humanitas is the lead sponsor of 275 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    MK5172 /MK8742

    Drug: MK5172 /MK8742

Interventions

  • DrugMK5172 /MK8742

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

06

What researchers measure

Primary outcomes

  1. 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).

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02732405
Lead sponsor
Istituto Clinico Humanitas
Collaborators
CD Pharma Group S.r.l.
Responsible party
Sponsor
First posted
Apr 8, 2016
Start date
May 2016
Primary completion
Dec 2016 (estimated)
Completion
Mar 2017 (estimated)
Last update
Apr 8, 2016

Study contacts

Savino Bruno, MD
Contact
savino.bruno@hunimed.eu

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hepatitis C→

Other studies from this sponsor

Istituto Clinico Humanitas

Start the discussion