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(MK7009) for the Treatment of Chronic Genotype 1 Hepatitis C Virus Infection in Treatment-naive Patients (MK-7009-019)(WITHDRAWN)

Chronic Genotype 1 Hepatitis C Virus Infection Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00895882
• Other study ID #: 7009-019
• Secondary ID: 2009_586
• Status: Withdrawn
• Phase: Phase 2
• First received: May 6, 2009
• Last updated: October 21, 2015
• Start date: November 2010
• Est. completion date: January 2013

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Genotype 1 Hepatitis C Virus Infection
• Hepatitis
• Hepatitis A
• Hepatitis C
• Infection
• Virus Diseases

Intervention

Drug:
• vaniprevir (MK7009)
vaniprevir 300 mg soft gel capsules twice daily.
• Comparator: vaniprevir (MK7009)
vaniprevir 600 mg soft gel capsules twice daily.
• Comparator: Pegylated Interferon (peg-IFN) alfa-2a
Peg-IFN 180 mcg/0.5 mL subcutaneous injection once weekly
• Comparator: Ribavirin
Ribavirin, at a total daily dose of 1000 mg or 1200 mg based on patient weight, will be administered twice daily.
• Comparator: Placebo to vaniprevir
Placebo to vaniprevir soft gel capsules twice daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients achieving SVR24 in Treatment Regimens 1 to 4		24 weeks after end of study therapy	No
Primary	Evaluate the safety and tolerability of the MK7009 treatment regiments as assessed by review of the accumulated safety data		72 Weeks	No
Secondary	1) Proportion of patients achieving SVR24 in Treatment Regimen 5		1) 24 weeks after end of study therapy	No