Phase 1 N=10 Diagnostic

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

Liver Fibrosis · Hepatitis C Virus

Bottom Line

View on ClinicalTrials.gov: NCT00896233 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2011

Primary outcome: Primary: Repeated Maximum Liver Elastic Stiffness (Kilopascal [kPa]) Measurements — 4.54; 4.64; 5.10; 5.14 kPa

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: MRE (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Jan 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Repeated Maximum Liver Elastic Stiffness (Kilopascal [kPa]) Measurements	4.54; 4.64; 5.10; 5.14	—
PRIMARY Repeated Mean Liver Elastic Stiffness (kPa) Measurements	3.12; 3.14; 3.08; 3.15	—
PRIMARY Percent Difference in Mean Liver Stiffness Between Hepatitis C Virus (HCV)- Positive Participants With Liver Fibrosis and Healthy Participants	94.41; 94.66; 97.02; 99.31	—
PRIMARY Percent Difference in Maximum Liver Stiffness Between HCV- Positive Participants With Liver Fibrosis and Healthy Participants	117.21; 91.24; 105.35; 90.77	—

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 validation of MRE as an alternative to liver biopsy.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00896233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.