Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-02-22 @ 7:03 PM
Study NCT ID:
NCT02465203
Status:
TERMINATED
Last Update Posted:
2018-01-12
First Post:
2015-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
3-year Follow-up Study to Assess the Viral Activity in Hepatitis C Patients Who Failed Feeder DEB025/Alisporivir Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'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': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+41613241111', 'title': 'Study Director', 'organization': 'Novartis'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Publications from a single site are postponed until publication of the pooled clinical trial data (i.e., data from all sites) or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'There is no statistical hypothesis for this single-arm uncontrolled terminated study. Study was powered for efficacy of 650 participants and only 105 were randomized'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'A2210', 'description': 'From Study A2210 (3 patients did not receive alisporivir in the feeder study and were excluded from Safety Set)', 'otherNumAtRisk': 53, 'otherNumAffected': 1, 'seriousNumAtRisk': 53, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'A2301', 'description': 'From Study A2301 (3 patients did not receive alisporivir in the feeder study and were excluded from Safety Set)', 'otherNumAtRisk': 33, 'otherNumAffected': 1, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'A2211 IFN-free', 'description': 'From Study A2211 IFN-free (subset of Study 2211 overall)', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'A2211 Overall', 'description': 'From Study A2211 Overall (1 patient did not receive alisporivir in the feeder study and was excluded from Safety Set)', 'otherNumAtRisk': 12, 'otherNumAffected': 4, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'HEPATIC STEATOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'BLOOD TRIGLYCERIDES INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'TOTAL BILE ACIDS INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'NECK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'CHOLECYSTITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'CHOLELITHIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'HAND FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'HEPATOCELLULAR CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HCV RNA Sequencing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Arms', 'description': 'All participants in study'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '27 months', 'description': 'Persistence of resistance associated variants', 'unitOfMeasure': 'Number of particiants', 'reportingStatus': 'POSTED', 'populationDescription': 'There was no hypothesis testing in this study, as the study was prematurely terminated.\n\n4 patients with resistance associated variants have been identified at study start. Study was not powered for 105 participants'}, {'type': 'SECONDARY', 'title': 'Safety Parameters as Measured by HCV RNA Sequencing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Arms', 'description': 'All participants in study'}], 'timeFrame': '27 months', 'description': 'Phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro', 'reportingStatus': 'POSTED', 'populationDescription': 'There was no hypothesis testing in this study, as the study was prematurely terminated.\n\nStudy was powered for efficacy of 650 participants, and only 105 were randomized\n\nNo data are available because data were not collected'}, {'type': 'SECONDARY', 'title': 'Safety Parameters as Measured by FibroScan/Fibrotest and Lab Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Arms', 'description': 'All participants in study'}], 'timeFrame': '27 months', 'description': 'Changes in liver function and disease over time', 'reportingStatus': 'POSTED', 'populationDescription': 'There was no hypothesis testing in this study, as the study was prematurely terminated.\n\nNo data for any pre-specified Outcomes were analyzed.\n\nThere was no hypothesis testing in this study, as the study was prematurely terminated.\n\nStudy was powered for 105 participants, not 650\n\nNo data are available because data were not collected'}, {'type': 'SECONDARY', 'title': 'Safety Parameters as Measured by Liver UltraSound and Lab Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Arms', 'description': 'All participants in study'}], 'timeFrame': '27 months', 'description': 'Development of hepatocellular carcinoma (HCC)', 'reportingStatus': 'POSTED', 'populationDescription': 'There was no hypothesis testing in this study, as the study was prematurely terminated.\n\nNo data for any pre-specified Outcomes were analyzed.\n\nThere was no hypothesis testing in this study, as the study was prematurely terminated.\n\nStudy was powered for 105 participants, not 650\n\nNo data are available because data were not collected'}, {'type': 'SECONDARY', 'title': 'Safety Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Arms', 'description': 'All participants in study'}], 'timeFrame': '27 months', 'description': 'Safety over time of previous alisporivir exposure', 'reportingStatus': 'POSTED', 'populationDescription': 'There was no hypothesis testing as the study was prematurely terminated. AE and SAE data are provided in the "Adverse Events" section\n\nThere was no hypothesis testing in this study, as the study was prematurely terminated.\n\nStudy was powered for 105 participants, not 650\n\nNo data are available because data were not collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'From Study 2210 (N=56)', 'description': 'Follow up from feeder study NCT01183169'}, {'id': 'FG001', 'title': 'From Study 2301 (N=36)', 'description': 'Follow up from withdrawn feeder study NCT01318694'}, {'id': 'FG002', 'title': 'From Study 2211 - Overall (N=13)', 'description': 'Follow up from feeder study NCT01215643'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'New therapy for study indication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Patient/guardian decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'From Study 2210 (N=56)', 'description': 'Follow up from feeder study NCT01183169'}, {'id': 'BG001', 'title': 'From Study 2301 (N=36)', 'description': 'Follow up from withdrawn feeder study NCT01318694'}, {'id': 'BG002', 'title': 'Study 2211 - Overall (N=13)', 'description': 'Follow up from feeder study NCT01215643'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.7', 'spread': '9.86', 'groupId': 'BG000'}, {'value': '53.8', 'spread': '10.57', 'groupId': 'BG001'}, {'value': '46.5', 'spread': '7.88', 'groupId': 'BG002'}, {'value': '52.3', 'spread': '10.06', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '26.35', 'spread': '3.76', 'groupId': 'BG000'}, {'value': '25.54', 'spread': '4.08', 'groupId': 'BG001'}, {'value': '26.24', 'spread': '4.12', 'groupId': 'BG002'}, {'value': '26.06', 'spread': '3.89', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline HCV RNA Load (log10 IU/mL)', 'classes': [{'categories': [{'measurements': [{'value': '6.32', 'spread': '1.3375', 'groupId': 'BG000'}, {'value': '6.19', 'spread': '0.5171', 'groupId': 'BG001'}, {'value': '6.17', 'spread': '1.1974', 'groupId': 'BG002'}, {'value': '6.26', 'spread': '1.0959', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'whyStopped': 'Study was prematurely terminated.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2014-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-13', 'studyFirstSubmitDate': '2015-03-17', 'resultsFirstSubmitDate': '2015-07-15', 'studyFirstSubmitQcDate': '2015-06-03', 'lastUpdatePostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-13', 'studyFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HCV RNA Sequencing', 'timeFrame': '27 months', 'description': 'Persistence of resistance associated variants'}], 'secondaryOutcomes': [{'measure': 'Safety Parameters as Measured by HCV RNA Sequencing', 'timeFrame': '27 months', 'description': 'Phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro'}, {'measure': 'Safety Parameters as Measured by FibroScan/Fibrotest and Lab Parameters', 'timeFrame': '27 months', 'description': 'Changes in liver function and disease over time'}, {'measure': 'Safety Parameters as Measured by Liver UltraSound and Lab Parameters', 'timeFrame': '27 months', 'description': 'Development of hepatocellular carcinoma (HCC)'}, {'measure': 'Safety Parameters', 'timeFrame': '27 months', 'description': 'Safety over time of previous alisporivir exposure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatitis C, chronic'], 'conditions': ['Hepatitis C, Chronic']}, 'descriptionModule': {'briefSummary': 'Follow-up for viral activity, changes in liver function and safety in patients with no SVR24 in feeder studies', 'detailedDescription': 'The purpose of this study was to follow patients from the feeder studies who have not achieved SVR24 to assess their viral activity, and to assess the changes in liver function and disease, and post-treatment safety over time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males or females aged ≥18\n2. Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir or a direct antiviral agent (DAA)\n3. Have not achieved SVR24\n\nExclusion Criteria:\n\n1. Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer.\n2. Previous use of any course of hepatitis C therapy since the end of the Novartis-sponsored hepatitis C study'}, 'identificationModule': {'nctId': 'NCT02465203', 'briefTitle': '3-year Follow-up Study to Assess the Viral Activity in Hepatitis C Patients Who Failed Feeder DEB025/Alisporivir Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multi-centre 3-year Follow-up Study to Assess the Viral Activity in Patients Who Failed to Achieve Sustained Virologic Response in Novartis-sponsored Alisporivir-studies for Chronic Hepatitis C Patients', 'orgStudyIdInfo': {'id': 'CDEB025A2313'}, 'secondaryIdInfos': [{'id': '2011-006132-24'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Follow up from feeder studies', 'description': 'Follow up arm', 'interventionNames': ['Drug: Previous treatment in DEB025 study']}], 'interventions': [{'name': 'Previous treatment in DEB025 study', 'type': 'DRUG', 'otherNames': ['Data was not collected'], 'description': 'Follow-up after DEB025 active study', 'armGroupLabels': ['Follow up from feeder studies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92101', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}, {'zip': '96814', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '62703', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '76012', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative 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