Safety and Efficacy of Vaniprevir (MK7009) Administered With Pegylated-Interferon and Ribavirin (MK-7009-007)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00704184
First received: June 23, 2008
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

A study to evaluate how effective different levels of Vaniprevir, when administered with Pegylated-Interferon and Ribavirin, are at achieving rapid viral response in patients with Hepatitis C infection.


Condition Intervention Phase
Hepatitis C
Drug: Comparator: vaniprevir (MK7009)
Drug: Comparator: pegylated interferon (peg-IFN)
Drug: Comparator: Ribavirin (RBV)
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: A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Treatment-Naive Patients With Chronic Hepatitis C Infection

Resource links provided by NLM:


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

Primary Outcome Measures:
  • proportion of patients achieving RVR (undetectable viral load) [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • safety and tolerability of vaniprevir compared with placebo as assessed by review of the accumulated safety data [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the log decreases in HCV viral RNA [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Enrollment: 182
Study Start Date: August 2008
Study Completion Date: April 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
vaniprevir 300 mg b.i.d. + peg-IFN + RBV
Drug: Comparator: vaniprevir (MK7009)
Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days
Other Name: MK7009
Drug: Comparator: pegylated interferon (peg-IFN)
peg-IFN; duration of treatment: 48 weeks
Drug: Comparator: Ribavirin (RBV)
RBV 22%; duration of treatment: 48 weeks
Experimental: 2
vaniprevir 600 mg b.i.d. + peg-IFN + RBV
Drug: Comparator: vaniprevir (MK7009)
Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days
Other Name: MK7009
Drug: Comparator: pegylated interferon (peg-IFN)
peg-IFN; duration of treatment: 48 weeks
Drug: Comparator: Ribavirin (RBV)
RBV 22%; duration of treatment: 48 weeks
Experimental: 3
vaniprevir 600 mg q.d. + peg-IFN + RBV
Drug: Comparator: vaniprevir (MK7009)
Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days
Other Name: MK7009
Drug: Comparator: pegylated interferon (peg-IFN)
peg-IFN; duration of treatment: 48 weeks
Drug: Comparator: Ribavirin (RBV)
RBV 22%; duration of treatment: 48 weeks
Experimental: 4
vaniprevir 800 mg q.d. + peg-IFN + RBV
Drug: Comparator: vaniprevir (MK7009)
Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days
Other Name: MK7009
Drug: Comparator: pegylated interferon (peg-IFN)
peg-IFN; duration of treatment: 48 weeks
Drug: Comparator: Ribavirin (RBV)
RBV 22%; duration of treatment: 48 weeks
Placebo Comparator: 5
Placebo + peg-IFN + RBV
Drug: Comparator: pegylated interferon (peg-IFN)
peg-IFN; duration of treatment: 48 weeks
Drug: Comparator: Ribavirin (RBV)
RBV 22%; duration of treatment: 48 weeks
Drug: Comparator: placebo
Matching placebo to vaniprevir; duration of treatment: 28 days

  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 Hepatitis C infection

Exclusion Criteria:

  • Subject has been previously treated for HCV
  • Has HIV
  • Has Hepatitis B
  • 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
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: NCT00704184

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00704184     History of Changes
Other Study ID Numbers: 7009-007, MK7009-007, 2007_658
Study First Received: June 23, 2008
Last Updated: November 18, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 16, 2014