Status:
COMPLETED
Magnetic Resonance Elastography for Assessment of Liver Fibrosis (MK-0000-132)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Liver Fibrosis
Hepatitis C Virus
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will assess the repeatability of Magnetic Resonance Elastography (MRE) in both healthy volunteers and Hepatitis C Virus (HCV)-infected patients with fibrosis and lay the groundwork for the ...
Eligibility Criteria
Inclusion
- Male or female and at least 18 years of age
- Generally good health
- Willing to fast for 8 hours prior to each study visit
- Hepatitis C Virus (HCV)
- Positive serology for HCV and detectable HCV ribonucleic acid (RNA) in blood within 12 weeks of screening;
- For Part I, known fibrosis stage of at least =F2 (METAVIR) or =F3 (Ishak) from biopsy performed within 3 months of screening; For Part 2, known fibrosis stage of F1-F4 (METAVIR) or F1-F6 (Ishak)
- Never been treated for HCV
- Healthy Participant
- Documented absence of hepatitis B virus, HCV, acute hepatitis A virus, and human immunodeficiency virus (HIV) within 12 weeks of screening
Exclusion
- History of stroke, seizures, or neurological disorders
- Consumption of excessive amounts of alcohol
- Use of products containing nicotine
- Unable to hold a breath for 20 seconds
- Claustrophobia
- Use of illicit drugs or history of drug or alcohol abuse
- HCV-Positive
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00896233
Start Date
August 1 2009
End Date
January 1 2010
Last Update
August 25 2015
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