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(MK7009) for the Treatment of Chronic Genotype 1 Hepatitis C Virus Infection in Treatment-naive Patients (MK-7009-019)(WITHDRAWN)

NCT00895882 | Withdrawn Phase 2 DMC

• 2 other identifiers: 7009-0192009_586
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Genotype 1 Hepatitis C Virus Infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 1) Proportion of patients achieving SVR24 in Treatment Regimen 5

  1) 24 weeks after end of study therapy

Study Arms (6)

1

EXPERIMENTAL

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); Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a; Drug: Comparator: Ribavirin; Drug: Comparator: Placebo to vaniprevir

2

EXPERIMENTAL

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

Drug: vaniprevir (MK7009); Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a; Drug: Comparator: Ribavirin

3

EXPERIMENTAL

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: vaniprevir (MK7009); Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a; Drug: Comparator: Ribavirin; Drug: Comparator: Placebo to vaniprevir

4

EXPERIMENTAL

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

Drug: Comparator: vaniprevir (MK7009); Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a; Drug: Comparator: Ribavirin

5

EXPERIMENTAL

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

Drug: Comparator: vaniprevir (MK7009); Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a; Drug: Comparator: Ribavirin

6

PLACEBO COMPARATOR

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; Drug: Comparator: Ribavirin; Drug: Comparator: Placebo to vaniprevir

Interventions

vaniprevir (MK7009) DRUG

vaniprevir 300 mg soft gel capsules twice daily.

1; 2

Comparator: vaniprevir (MK7009) DRUG

vaniprevir 600 mg soft gel capsules twice daily.

3; 4; 5

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

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

1; 2; 3; 4; 5; 6

Comparator: Ribavirin DRUG

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

1; 2; 3; 4; 5; 6

Comparator: Placebo to vaniprevir DRUG

Placebo to vaniprevir soft gel capsules twice daily.

1; 3; 6

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Interventions

vaniprevir

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2009
• First Posted: May 8, 2009
• Study Start: November 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: October 22, 2015

Record last verified: 2015-10