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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00518622
• Other study ID #: 7009-004
• Secondary ID: 2007_517
• Status: Completed
• Phase: Phase 1
• First received: August 17, 2007
• Last updated: August 11, 2015
• Start date: July 2007
• Est. completion date: September 2008

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Comparator: MK7009
Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
• Comparator: Placebo
MK7009 Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Lawitz E, Sulkowski M, Jacobson I, Kraft WK, Maliakkal B, Al-Ibrahim M, Gordon SC, Kwo P, Rockstroh JK, Panorchan P, Miller M, Caro L, Barnard R, Hwang PM, Gress J, Quirk E, Mobashery N. Characterization of vaniprevir, a hepatitis C virus NS3/4A protease — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability of MK7009	Number of participants who reported adverse experiences while on study medication as well as for 14 days after completion of study medication	14 days after completion of study therapy	Yes
Primary	Antiviral Activity of MK7009	Change from Baseline in Log10 IU/mL hepatitis C virus (HCV) ribonucleic acid (RNA) on Day 8	Baseline and Day 8	No