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MK-5172 Administered With Peginterferon and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C (MK-5172-003): 500 people comparing MK5172 to boceprevir, + peg/RBV
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MK-5172 Administered With Peginterferon and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C (MK-5172-003) Phase 2 Study
Official Title: A Randomized, Active-Controlled, Dose-Ranging Estimation Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-5172 When Administered Concomitantly With Peginterferon Alfa-2b and Ribavirin in Treatment-Naïve Patients With Chronic Genotype 1 Hepatitis C Virus Infection
This study is not yet open for participant recruitment.
Verified on May 2011 by Merck
First Received on May 12, 2011. Last Updated on May 13, 2011
This study will evaluate the safety, tolerability, and antiviral activity of MK-5172 when administered in combination with peginterferon and ribavirin in treatment-naïve patients with chronic hepatitis C.
Primary Outcome Measures:
· Number of Participants Achieving complete Early Viral Response (cEVR) in the MK-5172 Treatment Arms [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
· Number of Participants Achieving Sustained Viral Response 24 weeks After the End of All Study Therapy (SVR24) [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
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A Study of MK5172 in Hepatitis C Infected Male Patients (MK-5172-004 AM2)
A Study of MK5172 in Hepatitis C Infected Male Patients (MK-5172-004 AM2)
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK5172 in Hepatitis C Infected Male Patients
This study is currently recruiting participants.
Verified on April 2011 by Merck
This multiple dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK5172 in GT1(Genotype 1) and GT3 (Genotype 3) HCV (Hepatitis C Virus) infected patients.
Further study details as provided by Merck:
Primary Outcome Measures:
· Number of Patients with Clinical and Laboratory Adverse Experiences [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
· AUC (0-24hr) of MK5172 on Day 7 of dosing [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
· C (24hr) of MK5172 on Day 7 of dosing [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
· HCV viral load following administration of MK-5172 compared to placebo [ Time Frame: 2 months ] [ Designated as safety issue: No ]
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