Study the Safety and Effectiveness of MK7009 in Hepatitis C Infected Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

August 17, 2007

Last Updated Date

September 18, 2009

Start Date ^ICMJE

July 2007

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety and Tolerability of MK7009 [ Time Frame: 14 days after completion of study therapy ] [ Designated as safety issue: Yes ]
Antiviral Activity of MK7009 [ Time Frame: Baseline and Day 8 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Safety and Efficacy of the studied doses [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00518622 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Anti-viral activities of studies doses [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title ^ICMJE

Study the Safety and Effectiveness of MK7009 in Hepatitis C Infected Patients

Official Title ^ICMJE

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

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hepatitis C

Intervention ^ICMJE

Drug: Comparator: MK7009
Drug: Comparator: Placebo

Study Arms / Comparison Groups

Experimental: 25 mg b.i.d. MK7009
Experimental: 75 mg b.i.d. MK7009
Experimental: 250 mg b.i.d. MK7009
Experimental: 500 mg b.i.d. MK7009
Experimental: 700 mg b.i.d. MK7009
Experimental: 125 mg q.d. MK7009
Experimental: 600 mg q.d. MK7009
Experimental: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2009

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00518622

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2007_517, MK7009-004

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP