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

NCT00896233 | Completed Phase 1 Results

• 2 other identifiers: 0000-1322009_588
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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

Keywords

Staging of liver fibrosis prior to clinical trials for treatment of Hepatitis C Virus

Outcome Measures

Primary Outcomes (4)

• Repeated Maximum Liver Elastic Stiffness (Kilopascal [kPa]) Measurements

  Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the "Individual ROI" (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and "Common ROI" (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared. The mean was the overall mean of the data and the standard deviation was the within participant standard deviation.

  14 days

• Repeated Mean Liver Elastic Stiffness (kPa) Measurements

  Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single ROI that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the "Individual ROI" (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and "Common ROI" (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared. The mean was the overall mean of the data and the standard deviation was the within participant standard deviation.

  14 days

• Percent Difference in Mean Liver Stiffness Between Hepatitis C Virus (HCV)- Positive Participants With Liver Fibrosis and Healthy Participants

  Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the "Individual ROI" (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and "Common ROI" (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared.

  14 days

• Percent Difference in Maximum Liver Stiffness Between HCV- Positive Participants With Liver Fibrosis and Healthy Participants

  Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the "Individual ROI" (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and "Common ROI" (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared.

  14 days

Study Arms (1)

MRE

EXPERIMENTAL

Procedure: MRE

Interventions

MRE 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.

MRE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 21751289 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Hepatitis C

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis

Limitations and Caveats

Since both primary objectives were met based on the Part 1 analysis, a decision was made to stop the study and not proceed to Part 2. Therefore, data from Part 1 of the study were used for outcome measures 3 and 4 instead of data from Part 2.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2009
• First Posted: May 11, 2009
• Study Start: August 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: August 25, 2015
• Results First Posted: September 22, 2011

Record last verified: 2015-08