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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 1

Conditions

Hepatitis C

Treatments

Drug: Comparator: Placebo
Drug: Comparator: MK7009

Study type

Interventional

Funder types

Industry

Identifiers

NCT00518622
2007_517
7009-004

Details and patient eligibility

About

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

Enrollment

40 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 8 patient groups

1
Experimental group
Description:
25 mg b.i.d. MK7009
Treatment:
Drug: Comparator: MK7009
2
Experimental group
Description:
75 mg b.i.d. MK7009
Treatment:
Drug: Comparator: MK7009
3
Experimental group
Description:
250 mg b.i.d. MK7009
Treatment:
Drug: Comparator: MK7009
4
Experimental group
Description:
500 mg b.i.d. MK7009
Treatment:
Drug: Comparator: MK7009
5
Experimental group
Description:
700 mg b.i.d. MK7009
Treatment:
Drug: Comparator: MK7009
6
Experimental group
Description:
125 mg q.d. MK7009
Treatment:
Drug: Comparator: MK7009
7
Experimental group
Description:
600 mg q.d. MK7009
Treatment:
Drug: Comparator: MK7009
8
Experimental group
Description:
Placebo
Treatment:
Drug: Comparator: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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