Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-28 @ 12:05 PM
Study NCT ID:
NCT03669133
Status:
TERMINATED
Last Update Posted:
2023-07-25
First Post:
2018-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vitamin E for NASH Treatment in HIV Infected Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014810', 'term': 'Vitamin E'}], 'ancestors': [{'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'reginaw@iu.edu', 'phone': '317-278-3584', 'title': 'Regina Weber', 'organization': 'Indiana University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the time of enrollment until the end of the study, for a total of 28 weeks.', 'description': "Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.", 'eventGroups': [{'id': 'EG000', 'title': 'Group A', 'description': 'Vitamin E 800 IU/daily for 24 weeks\n\nVitamin E: Vitamin E 800 IU/daily', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group B', 'description': 'Matching placebo for 24 weeks\n\nPlacebos: Matching placebo daily', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'COVID', 'notes': 'Both participants, during the course of the study, contracted COVID.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in Liver Fat Content by Magnetic Resonance Proton-Density Fat Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin E 800 I/U', 'description': 'Vitamin E 800 IU/daily for 24 weeks\n\nVitamin E: Vitamin E 800 IU/daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo for 24 weeks\n\nPlacebos: Matching placebo daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at randomization visit (study day 1) and end of study visit (week 24)', 'description': 'change in liver steatosis via MRI-PDFF at randomization (day 1) and study completion (week 24) to assess liver steatosis', 'unitOfMeasure': 'percentage change', 'reportingStatus': 'POSTED', 'populationDescription': 'change in liver steatosis via MRI-PDFF or the one participant in each group'}, {'type': 'SECONDARY', 'title': 'Impact of Vitamin E Treatment on Noninvasive Markers of Hepatic Fibrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin E 800 I/U', 'description': 'Vitamin E 800 IU/daily for 24 weeks\n\nVitamin E: Vitamin E 800 IU/daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo for 24 weeks\n\nPlacebos: Matching placebo daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-28.3', 'groupId': 'OG000'}, {'value': '-0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'change from baseline (first screening visit) to the end of study visit (week 24)', 'description': 'This outcome measure reflects the change in liver stiffness in transient elastrography via FibroScan is measured in (kPa) for study participants at two study time points', 'unitOfMeasure': 'kPa - kilopascels', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in liver stiffness (LSM) via FibroScan for the one participant in each group'}, {'type': 'SECONDARY', 'title': 'Impact of Treatment on ALT as a Noninvasive Marker of Hepatic Inflammation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin E 800 I/U', 'description': 'Vitamin E 800 IU/daily for 24 weeks\n\nVitamin E: Vitamin E 800 IU/daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo for 24 weeks\n\nPlacebos: Matching placebo daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at randomization visit (study day 1) and end of study visit (week 24)', 'description': 'This measure reflects the change in ALT(IU/L) value for study participants at two study time points', 'unitOfMeasure': 'IU/L', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in ALT from study randomization (day 1) through the end of study visit (week 24)'}, {'type': 'SECONDARY', 'title': 'Impact of Treatment on AST as a Noninvasive Marker of Hepatic Inflammation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin E 800 I/U', 'description': 'Vitamin E 800 IU/daily for 24 weeks\n\nVitamin E: Vitamin E 800 IU/daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo for 24 weeks\n\nPlacebos: Matching placebo daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Change in AST from study randomization (day 1) through the end of study visit (week 24)', 'description': 'This measure reflects the change in AST(IU/L) value for study participants at two study time points', 'unitOfMeasure': 'IU/L', 'reportingStatus': 'POSTED', 'populationDescription': 'one participant completed each group'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vitamin E 800 I/U', 'description': 'Vitamin E 800 I/U daily for 24 weeks\n\nVitamin E: Vitamin E 800 I/U daily'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching placebo for 24 weeks\n\nPlacebos: Matching placebo daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '3 participants consented to participate in this trial. One person screen-failed and two completed the trial, with one randomized to each arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A', 'description': 'Vitamin E 800 IU/daily for 24 weeks\n\nVitamin E: Vitamin E 800 IU/daily'}, {'id': 'BG001', 'title': 'Group B', 'description': 'Matching placebo for 24 weeks\n\nPlacebos: Matching placebo daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50', 'spread': '8.49', 'groupId': 'BG000'}, {'value': '38', 'spread': '8.49', 'groupId': 'BG001'}, {'value': '44', 'spread': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Three people consented to enroll in this study; one participant screen failed and two completed the study'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-20', 'size': 433176, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-03T09:15', 'hasProtocol': True}, {'date': '2020-09-20', 'size': 103960, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-03T09:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Study biostatistician and Investigational Drug Services pharmacist will randomize subjects and will provide study drug'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group A: Vitamin E 800 IU/daily for 24 weeks. (total of 28 subjects) Group B: Matching placebo for 24 weeks (total of 28 subjects)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'lack of coordinator resources and lack of access to study resources during and due to the COVID pandemic', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-03', 'studyFirstSubmitDate': '2018-09-05', 'resultsFirstSubmitDate': '2023-05-17', 'studyFirstSubmitQcDate': '2018-09-11', 'lastUpdatePostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-03', 'studyFirstPostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Liver Fat Content by Magnetic Resonance Proton-Density Fat Fraction', 'timeFrame': 'at randomization visit (study day 1) and end of study visit (week 24)', 'description': 'change in liver steatosis via MRI-PDFF at randomization (day 1) and study completion (week 24) to assess liver steatosis'}], 'secondaryOutcomes': [{'measure': 'Impact of Vitamin E Treatment on Noninvasive Markers of Hepatic Fibrosis', 'timeFrame': 'change from baseline (first screening visit) to the end of study visit (week 24)', 'description': 'This outcome measure reflects the change in liver stiffness in transient elastrography via FibroScan is measured in (kPa) for study participants at two study time points'}, {'measure': 'Impact of Treatment on ALT as a Noninvasive Marker of Hepatic Inflammation', 'timeFrame': 'at randomization visit (study day 1) and end of study visit (week 24)', 'description': 'This measure reflects the change in ALT(IU/L) value for study participants at two study time points'}, {'measure': 'Impact of Treatment on AST as a Noninvasive Marker of Hepatic Inflammation', 'timeFrame': 'Change in AST from study randomization (day 1) through the end of study visit (week 24)', 'description': 'This measure reflects the change in AST(IU/L) value for study participants at two study time points'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fatty liver', 'NAFLD', 'NASH', 'HIV', 'Vitamin E'], 'conditions': ['NAFLD', 'NASH - Nonalcoholic Steatohepatitis', 'HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see how taking Vitamin E daily affects fatty liver in persons living with HIV. Subjects will have both HIV and a fatty liver and the purpose of the study is to learn if underlying liver condition (fatty liver) gets better, worse, or stays the same from taking Vitamin E.', 'detailedDescription': 'The investigators will conduct a proof-of-concept clinical trial to evaluate the efficacy of vitamin E for treatment of non-alcoholic steatohepatitis (NASH) in persons living with HIV. Hypothesis: Vitamin E will improve radiographically measured hepatic fat content and circulating markers of liver inflammation and injury in persons living with HIV who have NASH.\n\nA. Perform a pilot randomized placebo controlled trial of vitamin E 800 IU/daily for 6 months in 56 persons living with HIV with biopsy-proven NASH B. Measure change in liver fat content by magnetic resonance proton-density fat fraction (Primary outcome) C. Determine the impact of vitamin E treatment on noninvasive markers of hepatic and systemic inflammation, hepatic fibrosis, and systemic oxidative stress (Secondary outcomes) D. Define baseline hepatic gene expression signatures predictive of response to therapy.\n\nUpon completion, the proposed clinical trial may establish vitamin E as an excellent and inexpensive candidate for further development as a treatment for NASH in persons living with HIV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. males and females ≥18 years with biopsy-proven NASH within 6 months prior to enrollment\n2. histological diagnosis of NASH will be confirmed by an experienced liver pathologist before study entry\n3. HIV infection\n4. stable dose of anti-diabetic agents and ART in the 3 months preceding enrollment and expected by the physician treating diabetes and HIV to remain on stable medications during the study\n5. willingness to participate in the study\n6. ability to understand and give informed consent for participation\n\nExclusion Criteria:\n\n1. Presence of other chronic liver diseases (hepatitis B or C, autoimmune hepatitis, cholestatic liver disease, Wilson disease, hemochromatosis, etc.)\n2. average alcohol consumption \\>3 drinks/day for men or \\>2 drinks/day for women in the 6 months prior to enrollment.\n3. Alcohol Use Disorder Identification Test (AUDIT) score of ≥8\n4. evidence of cirrhosis on histology or imaging\n5. ongoing use of medications known to cause hepatic steatosis (e.g., corticosteroids, amiodarone, methotrexate, tetracycline, tamoxifen, estrogens at doses greater than those used for birth control, anabolic steroids, or valproic acid)\n6. prior bariatric surgery\n7. severe co-morbidities (e.g., advanced cardiac, renal, pulmonary, or psychiatric illness)\n8. allergy to vitamin E\n9. use of vitamin E or multivitamins containing vitamin E in the three months preceding enrollment\n10. use of drugs with potential effect on NASH such as ursodeoxycholic acid, S-adenosylmethionine (SAM-e), betaine, pentoxifylline, or milk thistle in the three months prior to enrollment.\n11. changing doses of statins (simvastatin, pravastatin, atorvastatin, fluvastatin, lovastatin, rosuvastatin) or fibrates (clofibrate, fenofibrate) in the three months prior enrollment.\n12. illicit substance abuse within the past twelve months\n13. breast feeding, pregnancy, inability or unwillingness to practice contraception for the duration of the study\n14. contraindications for the MRI procedure (e.g., prostheses, severe claustrophobia)\n15. poorly controlled diabetes with A1C \\>8.5 within in the last six months\n16. use of total parenteral nutrition in the 6 months preceding liver biopsy or enrollment'}, 'identificationModule': {'nctId': 'NCT03669133', 'briefTitle': 'Vitamin E for NASH Treatment in HIV Infected Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Vitamin E for NASH Treatment in HIV Infected Individuals', 'orgStudyIdInfo': {'id': '1807274844'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Vitamin E 800 IU/daily for 24 weeks', 'interventionNames': ['Drug: Vitamin E']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B', 'description': 'Matching placebo for 24 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vitamin E', 'type': 'DRUG', 'description': 'Vitamin E 800 IU/daily', 'armGroupLabels': ['Group A']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo daily', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Samer Gawrieh', 'investigatorAffiliation': 'Indiana University School of Medicine'}}}}