Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-02-13 @ 2:35 PM
Study NCT ID:
NCT02074995
Status:
TERMINATED
Last Update Posted:
2016-03-07
First Post:
2014-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Tolerability and Efficacy of BVS857 in Severe Burn Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}, {'id': 'D002100', 'term': 'Cachexia'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013851', 'term': 'Thinness'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialandresults.registries@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'BVS857 Grp 1A Open Label', 'description': '0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Adverse Events as a Measure of Safety and Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Grp 1A Open Label', 'description': '0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.'}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Over 1 year', 'description': 'Number of patients with adverse events as a measure of safety and tolerability', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Efficacy Measure by Change in Lean Body Mass (LBM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Grp 1A Open Label', 'description': '0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.'}], 'timeFrame': 'Groups 2,3&4: Baseline, Day 35, Day 85 and Day 106', 'description': 'Total LBM is measured by dual energy X-ray absorptiometry (DXA) scan.', 'reportingStatus': 'POSTED', 'populationDescription': 'Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided'}, {'type': 'SECONDARY', 'title': 'Serum Pharmacokinetics (PK) of BVS857: Cmax; The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Grp 1A Open Label', 'description': '0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.'}], 'timeFrame': 'Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105', 'reportingStatus': 'POSTED', 'populationDescription': 'Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided'}, {'type': 'SECONDARY', 'title': 'Serum Pharmacokinetics (PK) of BVS857: Tmax; The Time to Reach the Maximum Concentration After Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Grp 1A Open Label', 'description': '0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.'}], 'timeFrame': 'Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105', 'reportingStatus': 'POSTED', 'populationDescription': 'Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided'}, {'type': 'SECONDARY', 'title': 'Serum Pharmacokinetics (PK) of BVS857: AUClast; The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Grp 1A Open Label', 'description': '0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.'}], 'timeFrame': 'Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105', 'reportingStatus': 'POSTED', 'populationDescription': 'Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided'}, {'type': 'SECONDARY', 'title': 'Serum Pharmacokinetics (PK) of BVS857: AUCinf; The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to Infinity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Grp 1A Open Label', 'description': '0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.'}], 'timeFrame': 'Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105', 'reportingStatus': 'POSTED', 'populationDescription': 'Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided'}, {'type': 'SECONDARY', 'title': 'Serum Pharmacokinetics (PK) of BVS857: T1/2; The Terminal Elimination Half-life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Grp 1A Open Label', 'description': '0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.'}], 'timeFrame': 'Groups 1: Day 1through to Day 56: Groups 2,3&4:ay D1 through to Day 105', 'reportingStatus': 'POSTED', 'populationDescription': 'Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided'}, {'type': 'SECONDARY', 'title': 'Serum Pharmacokinetics (PK) of BVS857: CL; The Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Intravenous Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Grp 1A Open Label', 'description': '0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.'}], 'timeFrame': 'Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105', 'reportingStatus': 'POSTED', 'populationDescription': 'Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided'}, {'type': 'SECONDARY', 'title': 'Serum Pharmacokinetics (PK) of BVS857: Vz; The Volume of Distribution During the Terminal Elimination Phase Following Intravenous Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Grp 1A Open Label', 'description': '0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.'}], 'timeFrame': 'Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105', 'reportingStatus': 'POSTED', 'populationDescription': 'Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided'}, {'type': 'SECONDARY', 'title': 'Serum Pharmacokinetics (PK) of BVS857: Vss; The Volume of Distribution at Steady State Following Intravenous Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Grp 1A Open Label', 'description': '0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.'}], 'timeFrame': 'Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105', 'reportingStatus': 'POSTED', 'populationDescription': 'Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided'}, {'type': 'SECONDARY', 'title': 'Serum Pharmacokinetics (PK) of BVS857: Vz/F; The Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Grp 1A Open Label', 'description': '0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.'}], 'timeFrame': 'Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105', 'reportingStatus': 'POSTED', 'populationDescription': 'Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided'}, {'type': 'SECONDARY', 'title': 'Serum Pharmacokinetics (PK) of BVS857: CL/F; The Apparent Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Extravascular Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BVS857 Grp 1A Open Label', 'description': '0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.'}], 'timeFrame': 'Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105', 'reportingStatus': 'POSTED', 'populationDescription': 'Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BVS857 Grp 1A Open Label', 'description': '0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.'}, {'id': 'FG001', 'title': 'Placebo Group 1B/1C, 2, 3, 4'}, {'id': 'FG002', 'title': 'BVS857 Group 1B/1C, 2, 3, 4 Double Blind'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was planned to have 4 groups of patients. In Group 1: the bioavailability of BVS857 following subcutaneous administration was planned. Groups 2-4 (Group 4 optional) different BVS857 doses were planned for safety, PK and efficacy assessments. Study was terminated due to low enrollment as only 1 patient was enrolled'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'BVS857 Grp 1A Open Label', 'description': '0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'The study was prematurely terminated due to recruitment issues', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-03', 'studyFirstSubmitDate': '2014-02-27', 'resultsFirstSubmitDate': '2015-12-08', 'studyFirstSubmitQcDate': '2014-02-27', 'lastUpdatePostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-03', 'studyFirstPostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': 'Over 1 year', 'description': 'Number of patients with adverse events as a measure of safety and tolerability'}, {'measure': 'Efficacy Measure by Change in Lean Body Mass (LBM)', 'timeFrame': 'Groups 2,3&4: Baseline, Day 35, Day 85 and Day 106', 'description': 'Total LBM is measured by dual energy X-ray absorptiometry (DXA) scan.'}], 'secondaryOutcomes': [{'measure': 'Serum Pharmacokinetics (PK) of BVS857: Cmax; The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration', 'timeFrame': 'Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105'}, {'measure': 'Serum Pharmacokinetics (PK) of BVS857: Tmax; The Time to Reach the Maximum Concentration After Drug Administration', 'timeFrame': 'Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105'}, {'measure': 'Serum Pharmacokinetics (PK) of BVS857: AUClast; The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration', 'timeFrame': 'Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105'}, {'measure': 'Serum Pharmacokinetics (PK) of BVS857: AUCinf; The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to Infinity', 'timeFrame': 'Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105'}, {'measure': 'Serum Pharmacokinetics (PK) of BVS857: T1/2; The Terminal Elimination Half-life', 'timeFrame': 'Groups 1: Day 1through to Day 56: Groups 2,3&4:ay D1 through to Day 105'}, {'measure': 'Serum Pharmacokinetics (PK) of BVS857: CL; The Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Intravenous Administration', 'timeFrame': 'Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105'}, {'measure': 'Serum Pharmacokinetics (PK) of BVS857: Vz; The Volume of Distribution During the Terminal Elimination Phase Following Intravenous Administration', 'timeFrame': 'Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105'}, {'measure': 'Serum Pharmacokinetics (PK) of BVS857: Vss; The Volume of Distribution at Steady State Following Intravenous Administration', 'timeFrame': 'Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105'}, {'measure': 'Serum Pharmacokinetics (PK) of BVS857: Vz/F; The Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration', 'timeFrame': 'Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105'}, {'measure': 'Serum Pharmacokinetics (PK) of BVS857: CL/F; The Apparent Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Extravascular Administration', 'timeFrame': 'Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Burn, Severe burn, Lean body mass, Cachexia, Hypermetabolism, Catabolism, Wound healing'], 'conditions': ['Hypercatabolic Status Related to Severe Burn']}, 'descriptionModule': {'briefSummary': 'Study of tolerability and efficacy of BVS857 in severe burn subjects over 8 weeks and 15 weeks', 'detailedDescription': 'No formal analysis was performed as study was terminated due to low enrollment issues. (n=1 patient was enrolled)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Burn injury comprising 2nd degree deep partial thickness and/or 3rd degree full thickness burns, ≥20% total body surface area with expected need for surgical intervention and not exceeding the sum of age plus burn size of 100 (Baux score)\n* Dosing must occur within 8-12 days post-burn\n* Subjects must weigh at least 45kgs (for group 1 with doses of 0.03mg/kg) and be under 100 kg to participate in the study\n\nExclusion Criteria:\n\n* Spinal cord injury\n* Hypoxic brain injury (Glasgow Coma Scale (GCS) \\<8) at screening\n* True conductive electric burn with suspected neurologic injury\n* Uncontrolled diabetes with HbA1c \\> 10% at screening, or known history of hypoglycemia,\n* History of or active peripheral neuropathy or seizure disorder\n* Systemic corticosteroids : \\> 10mg/d of prednisone or equivalent, other investigational treatments (excluding investigational dressings), medications for weight loss including megestrol acetate, androgens or oral beta agonists'}, 'identificationModule': {'nctId': 'NCT02074995', 'briefTitle': 'Study of Tolerability and Efficacy of BVS857 in Severe Burn Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Multiple Ascending, Sequential, Placebo-controlled, Double-blind Study to Assess Safety, Tolerability and Efficacy of BVS857 in Severe Burn Subjects', 'orgStudyIdInfo': {'id': 'CBVS857X2201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BVS857 Grp 1A open label', 'description': '0.03 mg/kg of BVS857intravenously in open label manner', 'interventionNames': ['Biological: BVS857']}, {'type': 'EXPERIMENTAL', 'label': 'BVS857 Group 1B/1C, 2, 3, 4 Double Blind', 'interventionNames': ['Biological: BVS857']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group 1B/1C, 2, 3, 4', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'BVS857', 'type': 'BIOLOGICAL', 'description': 'Group 1A\\&1B receive first dose as IV then remaining doses as SC. Groups 2, 3 and 4 receive only SC doses.', 'armGroupLabels': ['BVS857 Group 1B/1C, 2, 3, 4 Double Blind', 'BVS857 Grp 1A open label']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'Group 1B receive first dose as IV then remaining doses as SC. Groups 2, 3 and 4 receive only SC doses.', 'armGroupLabels': ['Placebo Group 1B/1C, 2, 3, 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}