MK-5172 in Combination with MK-8742 in Treatment-Naïve Subjects

A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects with Chronic HCV GT1, GT4, GT5, and GT6 Infection - MK-5172 in Combination with MK-8742 in Treatment-Naïve Subjects

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000137-22-CZ

Enrollment

400

Registered

2014-04-02

Start date

2014-06-30

Completion date

Unknown

Last updated

2016-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Interventions

Product Name: MK-5172A Product Code: MK-5172A Pharmaceutical Form: Tablet Other descriptive name: MK-5172 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Other

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •You are greater than or equal to 18 years of age •You have chronic HCV GT1, GT4, GT5, GT6 •You have had a liver biopsy, Fibroscan or Fibrotest to check for cirrhosis or no cirrhosis •You are treatment naïve to all anti-HCV treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: •You have signs of decompensated liver disease •You are coninfected with Hepatitis B •You have signs of hepatocellular carcinoma or history of malignancy •You are taking or plan to take any medication not allowed for this study •You have a history of, or signs of, chronic hepatitis not caused by hepatitis C virus •You have an exclusionary laboratory value

Design outcomes

Primary

Measure	Time frame
Main Objective: •To evaluate the efficacy of MK-5172 in combination with MK-8742 as assessed by the proportion of subjects in the immediate treatment arm achieving SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy), defined as HCV RNA < LLOQ (either TD[u] or TND) 12 weeks after the end of all study therapy. •To evaluate the safety and tolerability of MK-5172 in combination with MK-8742.;Secondary Objective: •To evaluate the efficacy of MK-5172 in combination with MK-8742 as assessed by the proportion of subjects in the immediate treatment arm achieving SVR24 (Sustained Virologic Response 24 weeks after the end of all study therapy), defined as HCV RNA < LLOQ (either TD(u) or TND) 24 weeks after the end of all study therapy.;Primary end point(s): •The primary efficacy endpoint will be the SVR12 rate of the subjects in the immediate treatment arm. •The primary PK endpoints for MK-5172 and MK-8742 are, C2hr and Ctrough. Additional PK parameters such as AUC0-24 may be calculated using population pharmacokinetic modeling approaches ;Timepoint(s) of evaluation of this end point: SVR12	—

Measure

Time frame

Main Objective: •To evaluate the efficacy of MK-5172 in combination with MK-8742 as assessed by the proportion of subjects in the immediate treatment arm achieving SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy), defined as HCV RNA < LLOQ (either TD[u] or TND) 12 weeks after the end of all study therapy. •To evaluate the safety and tolerability of MK-5172 in combination with MK-8742.;Secondary Objective: •To evaluate the efficacy of MK-5172 in combination with MK-8742 as assessed by the proportion of subjects in the immediate treatment arm achieving SVR24 (Sustained Virologic Response 24 weeks after the end of all study therapy), defined as HCV RNA < LLOQ (either TD(u) or TND) 24 weeks after the end of all study therapy.;Primary end point(s): •The primary efficacy endpoint will be the SVR12 rate of the subjects in the immediate treatment arm. •The primary PK endpoints for MK-5172 and MK-8742 are, C2hr and Ctrough. Additional PK parameters such as AUC0-24 may be calculated using population pharmacokinetic modeling approaches ;Timepoint(s) of evaluation of this end point: SVR12

—

Secondary

Measure	Time frame
Secondary end point(s): •The secondary efficacy endpoint is the SVR24 rate of the subjects in the immediate treatment arm. ;Timepoint(s) of evaluation of this end point: SVR24	—

Countries

Australia, Czech Republic, Germany, Israel, Korea, Republic of, New Zealand, Puerto Rico, Sweden, Taiwan, United States

Contacts

Public ContactGlobal Clinical Trials Operations

Merck Sharp & Dohme Corp.

Nilou_mobashery@merck.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026