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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_588 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRE | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Hepatitis C Virus (HCV) Inclusion Criteria:
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)
Healthy Participant Inclusion Criteria:
Exclusion Criteria:
HCV-Positive Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21751289 | Derived | 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. |
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Part 2 of the study was not conducted; however, in Part 2 of the study, participants would have had a screening visit, followed ~1 month later by one imaging visit. The imaging visit would have consisted of two liver Magnetic Resonance Elastography (MRE) scans.
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| ID | Title | Description |
|---|---|---|
| FG000 | Magnetic Resonance Elastography (MRE) | In Part 1 of the study, participants had a screening visit, followed ~1 month later by two imaging visits over ~14 days. Each imaging visit consisted of two liver MRE scans. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Magnetic Resonance Elastography (MRE) | In Part 1 of the study, participants had a screening visit, followed ~1 month later by two imaging visits over ~14 days. Each imaging visit consisted of two liver MRE scans. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants analyzed were Completers. | Posted | Mean | Standard Deviation | kPa | 14 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Magnetic Resonance Elastography (MRE) | In Part 1 of the study, participants had a screening visit, followed ~1 month later by two imaging visits over ~14 days. Each imaging visit consisted of two liver MRE scans. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle soreness | Musculoskeletal and connective tissue disorders | MedDRA 13.0 |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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|
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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Reader 2 |
Participant scans evaluated by Reader 2. |
|
|
|
| Primary | 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. | Participants analyzed were Completers. | Posted | Mean | Standard Deviation | kPa | 14 days |
|
|
|
|
| Primary | 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. | Participants analyzed were Completers. | Posted | Number | 95% Confidence Interval | percent treatment difference | 14 days |
|
|
|
| Primary | 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. | Participants analyzed were Completers. | Posted | Number | 95% Confidence Interval | percent treatment difference | 14 days |
|
|
|
| 0 |
| 10 |
| 1 |
| 10 |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 13.0 |
|
| Red blood cells urine positive | Investigations | MedDRA 13.0 |
|
Publications derived from this study should include input from the investigators and SPONSOR personnel.Such input should be reflected in publication authorship.The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts,or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.
| ICC |
| 0.88 |
| 2-Sided |
| 90 |
| 0.78 |
| 0.99 |
| No |
| Superiority or Other |
| ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI. | ICC | 0.93 | 2-Sided | 90 | 0.87 | 1.00 | No | Superiority or Other |
| ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI. | ICC | 0.94 | 2-Sided | 90 | 0.88 | 1.00 | No | Superiority or Other |