Magnetic Resonance Elastography for Assessment of Liver Fibrosis (MK-0000-132)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Liver Fibrosis; Hepatitis C Virus

Treatments: Procedure: MRE

Study type: Interventional

Funder types: Industry

Identifiers

NCT00896233

2009_588

0000-132

Details and patient eligibility

About

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 validation of MRE as an alternative to liver biopsy.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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) Inclusion Criteria:

• 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 Inclusion Criteria:

• Documented absence of hepatitis B virus, HCV, acute hepatitis A virus, and human immunodeficiency virus (HIV) within 12 weeks of screening

Exclusion criteria

• 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 Exclusion Criteria:

• Evidence or history of chronic hepatitis not caused by HCV
• HIV

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

MRE

Experimental group

Treatment:

Procedure: MRE