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(MK7009) for the Treatment of Chronic Genotype 1 Hepatitis C Virus Infection in Treatment-naive Patients (MK-7009-019)(WITHDRAWN)

This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014