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

NCT ID: NCT00896233

Last Updated: 2015-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-01-31

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 validation of MRE as an alternative to liver biopsy.

Conditions

Liver Fibrosis; Hepatitis C Virus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

MRE

Group Type: EXPERIMENTAL

MRE

Intervention Type: PROCEDURE

Part 1: Participants will have a screening visit, followed ~1 month later by two imaging visits over ~14 days. Each imaging visit will consist of two liver MRE scans.

Part 2: Participants will have a screening visit, followed ~1

month later by one imaging visit. The imaging visit will consist

of two liver MRE scans.

Interventions

MRE

Part 1: Participants will have a screening visit, followed ~1 month later by two imaging visits over ~14 days. Each imaging visit will consist of two liver MRE scans.

Part 2: Participants will have a screening visit, followed ~1

month later by one imaging visit. The imaging visit will consist

of two liver MRE scans.

Intervention Type: PROCEDURE

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

• 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

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Shire NJ, Yin M, Chen J, Railkar RA, Fox-Bosetti S, Johnson SM, Beals CR, Dardzinski BJ, Sanderson SO, Talwalkar JA, Ehman RL. Test-retest repeatability of MR elastography for noninvasive liver fibrosis assessment in hepatitis C. J Magn Reson Imaging. 2011 Oct;34(4):947-55. doi: 10.1002/jmri.22716. Epub 2011 Jul 12.

Reference Type: DERIVED

PMID: 21751289 (View on PubMed)

Other Identifiers

2009_588

Identifier Type: -

Identifier Source: secondary_id

0000-132

Identifier Type: -

Identifier Source: org_study_id