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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(MK7009) for the Treatment of Chronic Genotype 1 Hepatitis C Virus Infection in Treatment-naive Patients (MK-7009-019)(WITHDRAWN)

Primary Purpose

Chronic Genotype 1 Hepatitis C Virus Infection

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

vaniprevir (MK7009)

Comparator: vaniprevir (MK7009)

Comparator: Pegylated Interferon (peg-IFN) alfa-2a

Comparator: Ribavirin

Comparator: Placebo to vaniprevir

About this trial

This is an interventional treatment trial for Chronic Genotype 1 Hepatitis C Virus Infection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

vaniprevir 300 mg b.i.d. + peg-IFN + RBV for 12 weeks, followed by placebo to vaniprevir + peg-IFN + RBV for 12 weeks

vaniprevir 300 mg b.i.d. + peg-IFN + RBV for 24 weeks

vaniprevir 600 mg b.i.d. + peg-IFN + RBV for 12 weeks, followed by placebo to vaniprevir + peg-IFN + RBV for 12 weeks

vaniprevir 600 mg b.i.d. + peg-IFN + RBV for 24 weeks

vaniprevir 600 mg q.d. + peg-IFN + RBV for 24 weeks

Placebo to vaniprevir + peg-IFN + RBV for 24 weeks, followed by peg-IFN + RBV for 24 weeks

Outcomes

Primary Outcome Measures

Proportion of patients achieving SVR24 in Treatment Regimens 1 to 4

Evaluate the safety and tolerability of the MK7009 treatment regiments as assessed by review of the accumulated safety data

Secondary Outcome Measures

1) Proportion of patients achieving SVR24 in Treatment Regimen 5

Full Information

NCT ID

NCT00895882

First Posted

May 6, 2009

Last Updated

October 21, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00895882

Brief Title

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)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Withdrawn

Study Start Date

November 2010 (undefined)

Primary Completion Date

January 2013 (Anticipated)

Study Completion Date

January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Genotype 1 Hepatitis C Virus Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

vaniprevir 300 mg b.i.d. + peg-IFN + RBV for 12 weeks, followed by placebo to vaniprevir + peg-IFN + RBV for 12 weeks

Arm Title

Arm Type

Experimental

Arm Description

vaniprevir 300 mg b.i.d. + peg-IFN + RBV for 24 weeks

Arm Title

Arm Type

Experimental

Arm Description

vaniprevir 600 mg b.i.d. + peg-IFN + RBV for 12 weeks, followed by placebo to vaniprevir + peg-IFN + RBV for 12 weeks

Arm Title

Arm Type

Experimental

Arm Description

vaniprevir 600 mg b.i.d. + peg-IFN + RBV for 24 weeks

Arm Title

Arm Type

Experimental

Arm Description

vaniprevir 600 mg q.d. + peg-IFN + RBV for 24 weeks

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo to vaniprevir + peg-IFN + RBV for 24 weeks, followed by peg-IFN + RBV for 24 weeks

Intervention Type

Drug

Intervention Name(s)

vaniprevir (MK7009)

Intervention Description

vaniprevir 300 mg soft gel capsules twice daily.

Intervention Type

Drug

Intervention Name(s)

Comparator: vaniprevir (MK7009)

Intervention Description

vaniprevir 600 mg soft gel capsules twice daily.

Intervention Type

Drug

Intervention Name(s)

Comparator: Pegylated Interferon (peg-IFN) alfa-2a

Intervention Description

Peg-IFN 180 mcg/0.5 mL subcutaneous injection once weekly

Intervention Type

Drug

Intervention Name(s)

Comparator: Ribavirin

Intervention Description

Ribavirin, at a total daily dose of 1000 mg or 1200 mg based on patient weight, will be administered twice daily.

Intervention Type

Drug

Intervention Name(s)

Comparator: Placebo to vaniprevir

Intervention Description

Placebo to vaniprevir soft gel capsules twice daily.

Primary Outcome Measure Information:

Title

Proportion of patients achieving SVR24 in Treatment Regimens 1 to 4

Time Frame

24 weeks after end of study therapy

Title

Evaluate the safety and tolerability of the MK7009 treatment regiments as assessed by review of the accumulated safety data

Time Frame

72 Weeks

Secondary Outcome Measure Information:

Title

1) Proportion of patients achieving SVR24 in Treatment Regimen 5

Time Frame

1) 24 weeks after end of study therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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)

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