Study the Safety and Effectiveness of MK7009 in Hepatitis C Infected Patients (MK-7009-004)(COMPLETED)

Phase 1

Completed

• Conditions: Hepatitis C

• Registration Number: NCT00518622
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-08-17
• Study First Submitted QC: 2007-08-17
• Study First Posted: 2007-08-21
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2009-08-10
• Results First Submitted QC: 2009-08-10
• Results First Posted: 2009-09-16
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-11
• Last Update Posted: 2015-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of MK7009	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	Baseline and Day 8	Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8