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A Study of Safety and Efficacy of Vaniprevir Administered With Pegylated-Interferon and Ribavirin in Japanese Patients With Chronic Hepatitis C Infection (7009-016)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00880763
First received: April 10, 2009
Last updated: April 9, 2012
Last verified: April 2012
History of Changes
  Purpose

The study evaluates safety and efficacy of vaniprevir (MK7009), when administered with Pegylated-Interferon and Ribavirin, in Japanese patients with Hepatitis C infection.


Condition Intervention Phase
Hepatitis C
 Drug: vaniprevir
Drug: Pegylated Interferon
Drug: Ribavirin
Drug: Comparator: Placebo
 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: Phase II Randomized Study to Evaluate Safety and Efficacy of MK7009 Administered With Pegylated-Interferon and Ribavirin in Japanese Treatment-Experienced Patients With Chronic Hepatitis C Infection

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Proportion of patients achieving viral response [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of vaniprevir as assessed by review of the accumulated safety data [ Time Frame: 42 Days ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: May 2009
Study Completion Date: February 2012
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
vaniprevir (200 mg) + Pegylated Interferon + Ribavirin
 Drug: vaniprevir
Vaniprevir Oral , twice daily (200, 600 or 1200 mg/day) for 28 days
Other Name: MK7009
Drug: Pegylated Interferon
Pegylated Interferon Subcutaneous injection, 180 micrograms weekly, for 28 days
Drug: Ribavirin
Ribavirin Oral, twice daily, 600 mg/day to 1000 mg /day, for 28 days
Experimental: 2
vaniprevir (600 mg) + Pegylated Interferon + Ribavirin
 Drug: vaniprevir
Vaniprevir Oral , twice daily (200, 600 or 1200 mg/day) for 28 days
Other Name: MK7009
Drug: Pegylated Interferon
Pegylated Interferon Subcutaneous injection, 180 micrograms weekly, for 28 days
Drug: Ribavirin
Ribavirin Oral, twice daily, 600 mg/day to 1000 mg /day, for 28 days
Experimental: 3
vaniprevir (1200 mg) + Pegylated Interferon + Ribavirin
 Drug: vaniprevir
Vaniprevir Oral , twice daily (200, 600 or 1200 mg/day) for 28 days
Other Name: MK7009
Drug: Pegylated Interferon
Pegylated Interferon Subcutaneous injection, 180 micrograms weekly, for 28 days
Drug: Ribavirin
Ribavirin Oral, twice daily, 600 mg/day to 1000 mg /day, for 28 days
Placebo Comparator: 4
Placebo + Pegylated Interferon + Ribavirin
 Drug: Pegylated Interferon
Pegylated Interferon Subcutaneous injection, 180 micrograms weekly, for 28 days
Drug: Ribavirin
Ribavirin Oral, twice daily, 600 mg/day to 1000 mg /day, for 28 days
Drug: Comparator: Placebo
Placebo to vaniprevir Oral, twice daily for 28 days

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient Has Chronic Genotype 1 Hepatitis C Infection

Exclusion Criteria:

  • Patient Has Not Tolerated Previous Course Of Peg-IFN And Ribavirin
  • Patient Has HIV
  • Patient Has Hepatitis B
  • Patient Has A History Of Clinically Significant Medical Condition That May Interfere With The Study (e.g., Stroke Or Chronic Seizures Or Major Neurological Disorder) Or Is Contraindicated For Treatment With Peg-IFN And Ribavirin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880763

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00880763     History of Changes
Other Study ID Numbers: 2009_576, MK7009-016
Study First Received: April 10, 2009
Last Updated: April 9, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
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 May 19, 2013