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Clinical Trials/NCT00518622
NCT00518622
Completed
Phase 1

A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of MK7009 in Hepatitis C Infected Patients

Merck Sharp & Dohme LLC0 sites40 target enrollmentJuly 2007
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ConditionsHepatitis C
DrugsComparator: MK7009Comparator: Placebo

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Hepatitis C
Sponsor
Merck Sharp & Dohme LLC
Enrollment
40
Primary Endpoint
Safety and Tolerability of MK7009
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

The purpose of this study is to investigate the effectiveness, safety, and tolerability of MK7009 in patients infected with Hepatitis C

Registry
clinicaltrials.gov
Start Date
July 2007
End Date
September 2008
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Subject is a man or a woman aged 18 to 55 years of age.
  • •Subject has chronic Hepatitis C
  • •Subject is willing to not use alcohol for 2 weeks prior to therapy and through the study follow-up period

Exclusion Criteria

  • •Patient has evidence of advanced liver disease.
  • •Patient has human immunodeficiency virus (HIV)
  • •Patient has Hepatitis B

Outcomes

Primary Outcomes

Safety and Tolerability of MK7009

Time Frame: 14 days after completion of study therapy

Number of participants who reported adverse experiences while on study medication as well as for 14 days after completion of study medication

Antiviral Activity of MK7009

Time Frame: Baseline and Day 8

Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8

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