Study to Evaluate Different Regimens of Vaniprevir (MK7009) for the Treatment of Chronic Genotype 1 Hepatitis C Virus Infection in Treatment-naive Patients (MK-7009-019)(WITHDRAWN)

A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 Hepatitis C Virus Infection

This study will evaluate the safety, tolerability, and efficacy of vaniprevir when administered concomitantly with pegylated interferon (peg-IFN) and ribavirin (RBV) to treat treatment-naive genotype 1 hepatitis C virus (HCV)-infected patients.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Genotype 1 Hepatitis C Virus Infection
• Intervention / Treatment: Drug: vaniprevir (MK7009); Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a; Drug: Comparator: Ribavirin; Drug: Comparator: Placebo to vaniprevir; Drug: Comparator: vaniprevir (MK7009)

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient has chronic genotype 1 HCV infection
• Patient has had a liver biopsy without evidence of cirrhosis
• Patient has had an eye exam prior to the start of study
• Female patients capable of having children and male patients with female partners capable of having children agree to use two forms of birth control throughout the study

Exclusion Criteria:

• Patient has had previous treatment with: 3 or more doses IFN, peg-IFN, and/or RBV; and stopped treatment due to intolerance of one of the drugs; other antiviral or investigational therapies or vaccines for HCV
• Female patient is pregnant or breastfeeding
• Patient has chronic hepatitis not caused by HCV
• Patient has evidence of cirrhosis of the liver
• Patient has HIV
• Patient has active hepatitis B infection
• Patient has non-genotype 1 HCV infection
• Patient consumes excessive amounts of alcohol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; vaniprevir 300 mg b.i.d. + peg-IFN + RBV for 12 weeks, followed by placebo to vaniprevir + peg-IFN + RBV for 12 weeks	Drug: vaniprevir (MK7009); vaniprevir 300 mg soft gel capsules twice daily.; Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a; Peg-IFN 180 mcg/0.5 mL subcutaneous injection once weekly; Drug: Comparator: Ribavirin; Ribavirin, at a total daily dose of 1000 mg or 1200 mg based on patient weight, will be administered twice daily.; Drug: Comparator: Placebo to vaniprevir; Placebo to vaniprevir soft gel capsules twice daily.
Experimental: 2; vaniprevir 300 mg b.i.d. + peg-IFN + RBV for 24 weeks	Drug: vaniprevir (MK7009); vaniprevir 300 mg soft gel capsules twice daily.; Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a; Peg-IFN 180 mcg/0.5 mL subcutaneous injection once weekly; Drug: Comparator: Ribavirin; Ribavirin, at a total daily dose of 1000 mg or 1200 mg based on patient weight, will be administered twice daily.
Experimental: 3; vaniprevir 600 mg b.i.d. + peg-IFN + RBV for 12 weeks, followed by placebo to vaniprevir + peg-IFN + RBV for 12 weeks	Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a; Peg-IFN 180 mcg/0.5 mL subcutaneous injection once weekly; Drug: Comparator: Ribavirin; Ribavirin, at a total daily dose of 1000 mg or 1200 mg based on patient weight, will be administered twice daily.; Drug: Comparator: Placebo to vaniprevir; Placebo to vaniprevir soft gel capsules twice daily.; Drug: Comparator: vaniprevir (MK7009); vaniprevir 600 mg soft gel capsules twice daily.
Experimental: 4; vaniprevir 600 mg b.i.d. + peg-IFN + RBV for 24 weeks	Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a; Peg-IFN 180 mcg/0.5 mL subcutaneous injection once weekly; Drug: Comparator: Ribavirin; Ribavirin, at a total daily dose of 1000 mg or 1200 mg based on patient weight, will be administered twice daily.; Drug: Comparator: vaniprevir (MK7009); vaniprevir 600 mg soft gel capsules twice daily.
Experimental: 5; vaniprevir 600 mg q.d. + peg-IFN + RBV for 24 weeks	Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a; Peg-IFN 180 mcg/0.5 mL subcutaneous injection once weekly; Drug: Comparator: Ribavirin; Ribavirin, at a total daily dose of 1000 mg or 1200 mg based on patient weight, will be administered twice daily.; Drug: Comparator: vaniprevir (MK7009); vaniprevir 600 mg soft gel capsules twice daily.
Placebo Comparator: 6; Placebo to vaniprevir + peg-IFN + RBV for 24 weeks, followed by peg-IFN + RBV for 24 weeks	Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a; Peg-IFN 180 mcg/0.5 mL subcutaneous injection once weekly; Drug: Comparator: Ribavirin; Ribavirin, at a total daily dose of 1000 mg or 1200 mg based on patient weight, will be administered twice daily.; Drug: Comparator: Placebo to vaniprevir; Placebo to vaniprevir soft gel capsules twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients achieving SVR24 in Treatment Regimens 1 to 4	24 weeks after end of study therapy
Evaluate the safety and tolerability of the MK7009 treatment regiments as assessed by review of the accumulated safety data	72 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
1) Proportion of patients achieving SVR24 in Treatment Regimen 5	1) 24 weeks after end of study therapy

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Anticipated): January 1, 2013
• Study Completion (Anticipated): January 1, 2013

Study Registration Dates

• First Submitted: May 6, 2009
• First Submitted That Met QC Criteria: May 7, 2009
• First Posted (Estimate): May 8, 2009

Study Record Updates

• Last Update Posted (Estimate): October 22, 2015
• Last Update Submitted That Met QC Criteria: October 21, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Blood-Borne Infections; Disease Attributes; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Infections; Communicable Diseases; Hepatitis; Hepatitis A; Hepatitis C; Virus Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Antineoplastic Agents; Interferons; Ribavirin
• Other Study ID Numbers: 7009-019; 2009_586