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Study the Safety and Effectiveness of MK7009 in Hepatitis C Infected Patients; And New HCV Drugs in development
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This study is currently recruiting participants.
Verified by Merck, April 2008
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of MK7009 in Hepatitis C Infected Patients
Further study details as provided by Merck:
Primary Outcome Measures:
* Safety and Efficacy of the studied doses [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
* Anti-viral activities of studies doses [ Time Frame: 8 Days ] [ Designated as safety issue: No ]
Stage 1:
A 50 mg b.i.d. B 75 mg b.i.d. C 150 mg b.i.d. D 250 mg b.i.d. E 125 mg q.d F 500 mg b.i.d. G 600 mg q.d H Placebo
Depending on group assignment, patients will receive once daily dosing for 8 days or twice daily dosing for 7 days plus one additional dose on Day 8.
Stage 2:
I 25 mg b.i.d. J 75 mg b.i.d. K 150 mg b.i.d L 300 mg b.i.d. M 400 mg b.i.d. N 500 mg b.i.d. O 150 mg q.d P 300 mg q.d Q 500 mg q.d R 600 mg q.d S 1000 mg q.d T Placebo
Depending on group assignment, patients will receive once daily dosing for 8 days or twice daily dosing for 7 days plus one additional dose on Day 8.
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
Contacts
Contact: Toll Free Number 1-888-577-8839
Locations
United States, Indiana
Call for Information Recruiting
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Call for Information Recruiting
Baton Rouge, Louisiana, United States, 70808
United States, Maryland
Call for Information Recruiting
Baltimore, Maryland, United States, 21287
Call for Information Recruiting
Baltimore, Maryland, United States, 21201
United States, Michigan
Call for Information Recruiting
Detroit, Michigan, United States, 48202-0000
United States, New Jersey
Call for Information Recruiting
Newark, New Jersey, United States, 17101-1709
United States, New York
Call for Information Recruiting
Rochester, New York, United States, 14534
Call for Information Recruiting
New York, New York, United States, 10021
Call for Information Recruiting
Manhasset, New York, United States, 11030-0000
United States, Pennsylvania
Call for Information Recruiting
Philadelphia, Pennsylvania, United States, 19107-5244
United States, Texas
Call for Information Recruiting
San Antonio, Texas, United States, 78215
Call for Information Recruiting
Dallas, Texas, United States, 75208
United States, Virginia
Call for Information Recruiting
Fairfax, Virginia, United States, 22031
Belgium
Merck Sharp & Dohme B.V. Recruiting
Bruxelles, Belgium, 1180
Contact: Nathalie Schrameijer 32-2-373-4310
Germany
Msd Sharp & Dohme Gmbh Recruiting
Haar, Germany, 85540
Contact: Thomas Lang 49-89-4561-1536
Hepatitis C New Drug Pipeline
New drugs in development for the treatment of hepatitis C
http://www.hcvdrugs.com/
Updated 14 April 2008 - Recent changes and additions are highlited
This information has been gathered from public sources, accuracy is not guaranteed
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