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(MK7009) for the Treatment of Chronic Genotype 1 Hepatitis C Virus Infection in Treatment-naive Patients (MK-7009-019)(WITHDRAWN)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00895882
First received: May 6, 2009
Last updated: February 28, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Chronic Genotype 1 Hepatitis C Virus Infection
Drug: vaniprevir (MK7009)
Drug: Comparator: vaniprevir (MK7009)
Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a
Drug: Comparator: Ribavirin
Drug: Comparator: Placebo to vaniprevir
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Proportion of patients achieving SVR24 in Treatment Regimens 1 to 4 [ Time Frame: 24 weeks after end of study therapy ] [ Designated as safety issue: No ]
  • Evaluate the safety and tolerability of the MK7009 treatment regiments as assessed by review of the accumulated safety data [ Time Frame: 72 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1) Proportion of patients achieving SVR24 in Treatment Regimen 5 [ Time Frame: 1) 24 weeks after end of study therapy ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: November 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: vaniprevir (MK7009)
vaniprevir 600 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: 4
vaniprevir 600 mg b.i.d. + peg-IFN + RBV for 24 weeks
Drug: Comparator: vaniprevir (MK7009)
vaniprevir 600 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: 5
vaniprevir 600 mg q.d. + peg-IFN + RBV for 24 weeks
Drug: Comparator: vaniprevir (MK7009)
vaniprevir 600 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895882

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00895882     History of Changes
Other Study ID Numbers: 2009_586, MK7009-019
Study First Received: May 6, 2009
Last Updated: February 28, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014