Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-30 @ 3:52 PM
Study NCT ID:
NCT00896233
Status:
COMPLETED
Last Update Posted:
2015-08-25
First Post:
2009-05-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Magnetic Resonance Elastography for Assessment of Liver Fibrosis (MK-0000-132)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Magnetic Resonance Elastography (MRE)', 'description': '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.', 'otherNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Muscle soreness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Red blood cells urine positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Repeated Maximum Liver Elastic Stiffness (Kilopascal [kPa]) Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reader 1', 'description': 'Participant scans evaluated by Reader 1.'}, {'id': 'OG001', 'title': 'Reader 2', 'description': 'Participant scans evaluated by Reader 2.'}], 'classes': [{'title': 'MRE Common ROI', 'categories': [{'measurements': [{'value': '4.54', 'spread': '0.48', 'groupId': 'OG000', 'lowerLimit': '0.82', 'upperLimit': '0.99'}, {'value': '4.64', 'spread': '0.50', 'groupId': 'OG001', 'lowerLimit': '0.72', 'upperLimit': '0.98'}]}]}, {'title': 'MRE Individual ROI', 'categories': [{'measurements': [{'value': '5.10', 'spread': '0.44', 'groupId': 'OG000', 'lowerLimit': '0.78', 'upperLimit': '0.98'}, {'value': '5.14', 'spread': '0.41', 'groupId': 'OG001', 'lowerLimit': '0.75', 'upperLimit': '0.98'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'ICC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.90', 'ciLowerLimit': '0.81', 'ciUpperLimit': '0.99', 'groupDescription': '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.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'ICC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.85', 'ciLowerLimit': '0.71', 'ciUpperLimit': '0.98', 'groupDescription': '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.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'ICC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.88', 'ciLowerLimit': '0.78', 'ciUpperLimit': '0.98', 'groupDescription': '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.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'ICC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.86', 'ciLowerLimit': '0.75', 'ciUpperLimit': '0.98', 'groupDescription': '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.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': '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.', 'unitOfMeasure': 'kPa', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed were Completers.'}, {'type': 'PRIMARY', 'title': 'Repeated Mean Liver Elastic Stiffness (kPa) Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reader 1', 'description': 'Participant scans evaluated by Reader 1.'}, {'id': 'OG001', 'title': 'Reader 2', 'description': 'Participant scans evaluated by Reader 2.'}], 'classes': [{'title': 'MRE Common ROI', 'categories': [{'measurements': [{'value': '3.12', 'spread': '0.26', 'groupId': 'OG000', 'lowerLimit': '0.80', 'upperLimit': '0.99'}, {'value': '3.14', 'spread': '0.31', 'groupId': 'OG001', 'lowerLimit': '0.78', 'upperLimit': '0.99'}]}]}, {'title': 'MRE Individual ROI', 'categories': [{'measurements': [{'value': '3.08', 'spread': '0.19', 'groupId': 'OG000', 'lowerLimit': '0.87', 'upperLimit': '1.00'}, {'value': '3.15', 'spread': '0.20', 'groupId': 'OG001', 'lowerLimit': '0.88', 'upperLimit': '1.00'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'ICC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.90', 'ciLowerLimit': '0.80', 'ciUpperLimit': '0.99', 'groupDescription': '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.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'ICC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.88', 'ciLowerLimit': '0.78', 'ciUpperLimit': '0.99', 'groupDescription': '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.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'ICC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.93', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.00', 'groupDescription': '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.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'ICC', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.94', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.00', 'groupDescription': '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.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': '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.', 'unitOfMeasure': 'kPa', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed were Completers.'}, {'type': 'PRIMARY', 'title': 'Percent Difference in Mean Liver Stiffness Between Hepatitis C Virus (HCV)- Positive Participants With Liver Fibrosis and Healthy Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reader 1', 'description': 'Participant scans evaluated by Reader 1.'}, {'id': 'OG001', 'title': 'Reader 2', 'description': 'Participant scans evaluated by Reader 2.'}], 'classes': [{'title': 'MRE Common ROI', 'categories': [{'measurements': [{'value': '94.41', 'groupId': 'OG000', 'lowerLimit': '33.85', 'upperLimit': '182.36'}, {'value': '94.66', 'groupId': 'OG001', 'lowerLimit': '32.65', 'upperLimit': '185.67'}]}]}, {'title': 'MRE Individual ROI', 'categories': [{'measurements': [{'value': '97.02', 'groupId': 'OG000', 'lowerLimit': '39.77', 'upperLimit': '177.73'}, {'value': '99.31', 'groupId': 'OG001', 'lowerLimit': '37.81', 'upperLimit': '188.27'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 days', 'description': '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.', 'unitOfMeasure': 'percent treatment difference', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed were Completers.'}, {'type': 'PRIMARY', 'title': 'Percent Difference in Maximum Liver Stiffness Between HCV- Positive Participants With Liver Fibrosis and Healthy Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reader 1', 'description': 'Participant scans evaluated by Reader 1.'}, {'id': 'OG001', 'title': 'Reader 2', 'description': 'Participant scans evaluated by Reader 2.'}], 'classes': [{'title': 'MRE Common ROI', 'categories': [{'measurements': [{'value': '117.21', 'groupId': 'OG000', 'lowerLimit': '33.70', 'upperLimit': '252.87'}, {'value': '91.24', 'groupId': 'OG001', 'lowerLimit': '32.12', 'upperLimit': '176.83'}]}]}, {'title': 'MRE Individual ROI', 'categories': [{'measurements': [{'value': '105.35', 'groupId': 'OG000', 'lowerLimit': '38.51', 'upperLimit': '204.42'}, {'value': '90.77', 'groupId': 'OG001', 'lowerLimit': '34.64', 'upperLimit': '170.29'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 days', 'description': '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.', 'unitOfMeasure': 'percent treatment difference', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed were Completers.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Magnetic Resonance Elastography (MRE)', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Claustrophobia during MRI', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Magnetic Resonance Elastography (MRE)', 'description': '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.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'spread': '12.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-11', 'studyFirstSubmitDate': '2009-05-07', 'resultsFirstSubmitDate': '2011-01-18', 'studyFirstSubmitQcDate': '2009-05-08', 'lastUpdatePostDateStruct': {'date': '2015-08-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-08-17', 'studyFirstPostDateStruct': {'date': '2009-05-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Repeated Maximum Liver Elastic Stiffness (Kilopascal [kPa]) Measurements', 'timeFrame': '14 days', 'description': '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.'}, {'measure': 'Repeated Mean Liver Elastic Stiffness (kPa) Measurements', 'timeFrame': '14 days', 'description': '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.'}, {'measure': 'Percent Difference in Mean Liver Stiffness Between Hepatitis C Virus (HCV)- Positive Participants With Liver Fibrosis and Healthy Participants', 'timeFrame': '14 days', 'description': '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.'}, {'measure': 'Percent Difference in Maximum Liver Stiffness Between HCV- Positive Participants With Liver Fibrosis and Healthy Participants', 'timeFrame': '14 days', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Staging of liver fibrosis prior to clinical trials for treatment of Hepatitis C Virus'], 'conditions': ['Liver Fibrosis', 'Hepatitis C Virus']}, 'referencesModule': {'references': [{'pmid': '21751289', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female and at least 18 years of age\n* Generally good health\n* Willing to fast for 8 hours prior to each study visit\n\nHepatitis C Virus (HCV) Inclusion Criteria:\n\n* Positive serology for HCV and detectable HCV ribonucleic acid (RNA) in blood within 12 weeks of screening;\n\nFor 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)\n\n* Never been treated for HCV\n\nHealthy Participant Inclusion Criteria:\n\n* Documented absence of hepatitis B virus, HCV, acute hepatitis A virus, and human immunodeficiency virus (HIV) within 12 weeks of screening\n\nExclusion Criteria:\n\n* History of stroke, seizures, or neurological disorders\n* Consumption of excessive amounts of alcohol\n* Use of products containing nicotine\n* Unable to hold a breath for 20 seconds\n* Claustrophobia\n* Use of illicit drugs or history of drug or alcohol abuse\n\nHCV-Positive Exclusion Criteria:\n\n* Evidence or history of chronic hepatitis not caused by HCV\n* HIV'}, 'identificationModule': {'nctId': 'NCT00896233', 'briefTitle': 'Magnetic Resonance Elastography for Assessment of Liver Fibrosis (MK-0000-132)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Test-Retest Repeatability Study of Magnetic Resonance Elastography (MRE) for Liver Fibrosis Assessment in Healthy Volunteers and Hepatitis C Virus-Infected Patients', 'orgStudyIdInfo': {'id': '0000-132'}, 'secondaryIdInfos': [{'id': '2009_588'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MRE', 'interventionNames': ['Procedure: MRE']}], 'interventions': [{'name': 'MRE', 'type': 'PROCEDURE', 'description': '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.\n\nPart 2: Participants will have a screening visit, followed \\~1\n\nmonth later by one imaging visit. The imaging visit will consist\n\nof two liver MRE scans.', 'armGroupLabels': ['MRE']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}