Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-28 @ 6:34 AM
Study NCT ID:
NCT01973504
Status:
WITHDRAWN
Last Update Posted:
2013-10-31
First Post:
2013-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2c Dose Comparison Study of MP4OX in Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012771', 'term': 'Shock, Hemorrhagic'}, {'id': 'D000140', 'term': 'Acidosis, Lactic'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C557204', 'term': 'polynitroxylated pegylated hemoglobin'}, {'id': 'C493836', 'term': 'maleimide-polyethylene glycol-modified hemoglobin, MP4'}, {'id': 'C109960', 'term': 'PEG-hemoglobin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sangart ceased operations', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-10-25', 'studyFirstSubmitDate': '2013-08-20', 'studyFirstSubmitQcDate': '2013-10-25', 'lastUpdatePostDateStruct': {'date': '2013-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Daily modified Denver Score', 'timeFrame': 'Day 7'}, {'measure': 'Proportion of patients with persistent renal dysfunction', 'timeFrame': 'Day 60'}, {'measure': 'Duration of ICU stay for survivors', 'timeFrame': 'Day 28 and Day 60'}, {'measure': 'Proportion of subjects who normalize lactate', 'timeFrame': '4 hours'}], 'primaryOutcomes': [{'measure': 'Proportion of subjects discharged from hospital through Day 28 and alive at the Day 28 Follow up visit', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Hospital-free, ICU-free, and Ventilator-free days', 'timeFrame': 'Through 28 and 60 days'}, {'measure': 'Proportion of subjects remaining in hospital, ICU or on ventilator', 'timeFrame': 'Through 28 and 60 days'}, {'measure': 'Days in hospital, in ICU, or on Ventilator', 'timeFrame': 'Through 28 and 60 days'}, {'measure': 'All-cause Mortality', 'timeFrame': 'At 48 hours and 28 or 60 days'}, {'measure': 'Time to discharge from ICU, hospital discharge, or liberation from ventilation', 'timeFrame': 'Through 28 or 60 days'}, {'measure': 'Composite of Time to Complete Organ Failure Resolution (CTCOFR)', 'timeFrame': 'Day 21'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Trauma', 'Hemorrhagic shock', 'Hemorrhage', 'Lactic acidosis', 'Oxygen therapeutics', 'Oxygen carriers', 'Ischemic rescue therapy', 'Hemoglobin solutions', 'PEGylated hemoglobin'], 'conditions': ['Trauma', 'Hemorrhagic Shock', 'Lactic Acidosis']}, 'referencesModule': {'references': [{'pmid': '21445773', 'type': 'BACKGROUND', 'citation': 'Cole RH, Vandegriff KD. MP4, a vasodilatory PEGylated hemoglobin. Adv Exp Med Biol. 2011;701:85-90. doi: 10.1007/978-1-4419-7756-4_12.'}, {'pmid': '18948027', 'type': 'BACKGROUND', 'citation': 'Young MA, Lohman J, Malavalli A, Vandegriff KD, Winslow RM. Hemospan improves outcome in a model of perioperative hemodilution and blood loss in the rat: comparison with hydroxyethyl starch. J Cardiothorac Vasc Anesth. 2009 Jun;23(3):339-47. doi: 10.1053/j.jvca.2008.08.006. Epub 2008 Oct 22.'}, {'pmid': '19178457', 'type': 'BACKGROUND', 'citation': 'Vandegriff KD, Winslow RM. Hemospan: design principles for a new class of oxygen therapeutic. Artif Organs. 2009 Feb;33(2):133-8. doi: 10.1111/j.1525-1594.2008.00697.x.'}, {'pmid': '18837531', 'type': 'BACKGROUND', 'citation': 'Vandegriff KD, Malavalli A, Mkrtchyan GM, Spann SN, Baker DA, Winslow RM. Sites of modification of hemospan, a poly(ethylene glycol)-modified human hemoglobin for use as an oxygen therapeutic. Bioconjug Chem. 2008 Nov 19;19(11):2163-70. doi: 10.1021/bc8002666.'}, {'pmid': '17827244', 'type': 'BACKGROUND', 'citation': 'Svergun DI, Ekstrom F, Vandegriff KD, Malavalli A, Baker DA, Nilsson C, Winslow RM. Solution structure of poly(ethylene) glycol-conjugated hemoglobin revealed by small-angle X-ray scattering: implications for a new oxygen therapeutic. Biophys J. 2008 Jan 1;94(1):173-81. doi: 10.1529/biophysj.107.114314. Epub 2007 Sep 7.'}, {'pmid': '17418478', 'type': 'BACKGROUND', 'citation': 'Cole RH, Vandegriff KD, Szeri AJ, Savas O, Baker DA, Winslow RM. A quantitative framework for the design of acellular hemoglobins as blood substitutes: implications of dynamic flow conditions. Biophys Chem. 2007 Jun;128(1):63-74. doi: 10.1016/j.bpc.2007.03.004. Epub 2007 Mar 13.'}, {'pmid': '16096458', 'type': 'BACKGROUND', 'citation': 'Young MA, Riddez L, Kjellstrom BT, Bursell J, Winslow F, Lohman J, Winslow RM. MalPEG-hemoglobin (MP4) improves hemodynamics, acid-base status, and survival after uncontrolled hemorrhage in anesthetized swine. Crit Care Med. 2005 Aug;33(8):1794-804. doi: 10.1097/01.ccm.0000172648.55309.13.'}, {'pmid': '14729723', 'type': 'BACKGROUND', 'citation': 'Drobin D, Kjellstrom BT, Malm E, Malavalli A, Lohman J, Vandegriff KD, Young MA, Winslow RM. Hemodynamic response and oxygen transport in pigs resuscitated with maleimide-polyethylene glycol-modified hemoglobin (MP4). J Appl Physiol (1985). 2004 May;96(5):1843-53. doi: 10.1152/japplphysiol.00530.2003. Epub 2004 Jan 16.'}, {'pmid': '15208289', 'type': 'BACKGROUND', 'citation': 'Winslow RM, Lohman J, Malavalli A, Vandegriff KD. Comparison of PEG-modified albumin and hemoglobin in extreme hemodilution in the rat. J Appl Physiol (1985). 2004 Oct;97(4):1527-34. doi: 10.1152/japplphysiol.00404.2004. Epub 2004 Jun 18.'}, {'pmid': '15175010', 'type': 'BACKGROUND', 'citation': 'Vandegriff KD, Bellelli A, Samaja M, Malavalli A, Brunori M, Winslow RM. Kinetics of NO and O2 binding to a maleimide poly(ethylene glycol)-conjugated human haemoglobin. Biochem J. 2004 Aug 15;382(Pt 1):183-9. doi: 10.1042/BJ20040156.'}, {'pmid': '12805024', 'type': 'BACKGROUND', 'citation': 'Tsai AG, Vandegriff KD, Intaglietta M, Winslow RM. Targeted O2 delivery by low-P50 hemoglobin: a new basis for O2 therapeutics. Am J Physiol Heart Circ Physiol. 2003 Oct;285(4):H1411-9. doi: 10.1152/ajpheart.00307.2003. Epub 2003 Jun 12.'}, {'pmid': '12662285', 'type': 'BACKGROUND', 'citation': 'Vandegriff KD, Malavalli A, Wooldridge J, Lohman J, Winslow RM. MP4, a new nonvasoactive PEG-Hb conjugate. Transfusion. 2003 Apr;43(4):509-16. doi: 10.1046/j.1537-2995.2003.00341.x.'}, {'pmid': '11527583', 'type': 'BACKGROUND', 'citation': 'McCarthy MR, Vandegriff KD, Winslow RM. The role of facilitated diffusion in oxygen transport by cell-free hemoglobins: implications for the design of hemoglobin-based oxygen carriers. Biophys Chem. 2001 Aug 30;92(1-2):103-17. doi: 10.1016/s0301-4622(01)00194-6.'}, {'pmid': '18212644', 'type': 'BACKGROUND', 'citation': 'Young MA, Riddez L, Kjellstrom BT, Winslow RM. Effect of maleimide-polyethylene glycol hemoglobin (MP4) on hemodynamics and acid-base status after uncontrolled hemorrhage in anesthetized swine: comparison with crystalloid and blood. J Trauma. 2007 Dec;63(6):1234-44. doi: 10.1097/TA.0b013e31815bd7b0.'}, {'pmid': '12794426', 'type': 'BACKGROUND', 'citation': 'Wettstein R, Tsai AG, Erni D, Winslow RM, Intaglietta M. Resuscitation with polyethylene glycol-modified human hemoglobin improves microcirculatory blood flow and tissue oxygenation after hemorrhagic shock in awake hamsters. Crit Care Med. 2003 Jun;31(6):1824-30. doi: 10.1097/01.CCM.0000069340.16319.F2.'}, {'pmid': '12727572', 'type': 'BACKGROUND', 'citation': 'Husain FA, Martin MJ, Mullenix PS, Steele SR, Elliott DC. Serum lactate and base deficit as predictors of mortality and morbidity. Am J Surg. 2003 May;185(5):485-91. doi: 10.1016/s0002-9610(03)00044-8.'}, {'pmid': '23168430', 'type': 'BACKGROUND', 'citation': 'Regnier MA, Raux M, Le Manach Y, Asencio Y, Gaillard J, Devilliers C, Langeron O, Riou B. Prognostic significance of blood lactate and lactate clearance in trauma patients. Anesthesiology. 2012 Dec;117(6):1276-88. doi: 10.1097/ALN.0b013e318273349d.'}, {'pmid': '11754855', 'type': 'BACKGROUND', 'citation': 'McNelis J, Marini CP, Jurkiewicz A, Szomstein S, Simms HH, Ritter G, Nathan IM. Prolonged lactate clearance is associated with increased mortality in the surgical intensive care unit. Am J Surg. 2001 Nov;182(5):481-5. doi: 10.1016/s0002-9610(01)00755-3.'}, {'pmid': '8411283', 'type': 'BACKGROUND', 'citation': 'Abramson D, Scalea TM, Hitchcock R, Trooskin SZ, Henry SM, Greenspan J. Lactate clearance and survival following injury. J Trauma. 1993 Oct;35(4):584-8; discussion 588-9. doi: 10.1097/00005373-199310000-00014.'}, {'pmid': '16857991', 'type': 'BACKGROUND', 'citation': 'Tsai AG, Cabrales P, Manjula BN, Acharya SA, Winslow RM, Intaglietta M. Dissociation of local nitric oxide concentration and vasoconstriction in the presence of cell-free hemoglobin oxygen carriers. Blood. 2006 Nov 15;108(10):3603-10. doi: 10.1182/blood-2006-02-005272. Epub 2006 Jul 20.'}], 'seeAlsoLinks': [{'url': 'http://www.sangart.com', 'label': 'Sangart Inc. (San Diego, CA) web site \\[Study SPONSOR\\]'}]}, 'descriptionModule': {'briefSummary': 'MP4OX is being developed as an ischemic rescue therapy to perfuse and oxygenate tissues at risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid designed to improve perfusion and target delivery of oxygen to ischemic tissues. This study will evaluate safety and efficacy of MP4OX treatment, in addition to standard therapy, in trauma patients suffering from lactic acidosis due to severe hemorrhagic shock.', 'detailedDescription': 'Acute trauma, including both blunt and penetrating injury, is often associated with uncontrolled bleeding that leads to hemorrhagic shock. During shock, inadequate blood flow results in local ischemia and tissue hypoxia (insufficient oxygenation) of critical organs with resulting lactic acidosis. More than 10% of trauma victims who reach hospital alive will die, and many will suffer from organ failure. The primary goal when treating traumatic hemorrhage is to control blood loss, support ventilation and oxygenation, and maintain cardiovascular function to maintain organ perfusion.\n\nDespite optimal care, organ dysfunction is present in many patients as evidenced by persistent lactic acidosis. Blood transfusions are intended to improve circulation of oxygen-carrying red blood cells, but are frequently insufficient, even when the hemoglobin level is optimized. The severity of lactic acidosis in trauma victims has also been shown to correlate with worse outcome.\n\nSupport for the proposed application for MP4OX as a therapeutic adjunct to standard treatment of severe hemorrhage shock, is based on multiple preclinical studies in different animal models of hemorrhagic shock resuscitation. These preclinical studies demonstrated that survival was greater and restoration of acid-base status and hemodynamics were improved with MP4OX. The benefits of MP4OX in animals were observed with or without co-administration of autologous blood, demonstrating that red cell transfusion alone was insufficient, and that the effects of MP4OX were additive.\n\nThe hypothesis for the current study is that MP4OX will enhance perfusion and oxygenation of ischemic organs and thereby prevent and reduce the duration of organ failure and improve morbidity and mortality outcome measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Trauma injury (blunt and/or penetrating) resulting in lactic acidosis due to hemorrhagic shock\n* Acidosis (blood lactate level ≥ 5 mmol/L; equivalent to 45 mg/dL)\n\nExclusion Criteria:\n\n* Massive injury incompatible with life\n* Normalization of lactate prior to dosing (≤ 2.2 mmol/L)\n* Evidence of severe traumatic brain injury (TBI) as defined by ANY one of the following: Known non-survivable head injury or open brain injury; Known AIS (head region) ≥ 4 by an appropriate imaging methodology; Contemplated CNS surgery; Abnormal physical exam indicative of severe CNS or any spinal cord injury above T5 level; or Glasgow Coma Score (GCS) = 3, 4 or 5.\n* Cardiac arrest prior to randomization\n* Known age below the legal age for consenting\n* Estimated time from injury to randomization \\> 4 hours\n* Estimated time from hospital admission to randomization \\> 2 hours\n* Known pregnancy\n* Use of any oxygen carrier other than RBCs\n* Known previous participation in this study\n* Professional or ancillary personnel involved with this study\n* Known receipt of any investigational drug(s) within 30 days prior to study'}, 'identificationModule': {'nctId': 'NCT01973504', 'briefTitle': 'Phase 2c Dose Comparison Study of MP4OX in Trauma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sangart'}, 'officialTitle': 'A Multi-center, Multinational, Randomized, Double-blind, Controlled, Dose Comparison Study to Evaluate Safety and Efficacy of MP4OX Plus Standard Treatment, in Severely Injured Trauma Subjects With Lactic Acidosis Due to Hemorrhagic Shock', 'orgStudyIdInfo': {'id': 'TRA-207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MP4OX 500-mL', 'description': '500-mL dose of MP4OX', 'interventionNames': ['Drug: MP4OX']}, {'type': 'EXPERIMENTAL', 'label': 'MP4OX 750-mL', 'description': '750-mL dose of MP4OX', 'interventionNames': ['Drug: MP4OX']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Standard crystalloid Keep Vein Open (KVO) infusion', 'interventionNames': ['Drug: Control']}], 'interventions': [{'name': 'MP4OX', 'type': 'DRUG', 'otherNames': ['Hemoglobin pegylated', 'MalPEG-Hb', 'MP4', 'PEG-Hb', 'Pegylated-Hb'], 'description': '4.3 g/dL pegylated hemoglobin in balanced lactate-electrolyte solution', 'armGroupLabels': ['MP4OX 500-mL', 'MP4OX 750-mL']}, {'name': 'Control', 'type': 'DRUG', 'otherNames': ['Keep vein open (KVO) infusion', 'Sham infusion'], 'description': 'Crystalloid solution IV infusion drip to keep vein open', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Liverpool', 'country': 'Australia', 'facility': 'Liverpool Hospital', 'geoPoint': {'lat': -33.91938, 'lon': 150.92588}}, {'city': 'Newcastle', 'country': 'Australia', 'facility': 'John Hunter Hospital', 'geoPoint': {'lat': -32.92953, 'lon': 151.7801}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Erasme University Hospital', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Edegem', 'country': 'Belgium', 'facility': 'University Hospital Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'city': 'São José do Rio Preto', 'country': 'Brazil', 'facility': 'Faculdade de Medicina de S. J. Do Rio Preto', 'geoPoint': {'lat': -20.81972, 'lon': -49.37944}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hopital Universitário, Centro de Estudos em Emergências em Saúde, USP Ribeirão Preto', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo - FMUSP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Clichy', 'country': 'France', 'facility': 'Hôpital Beaujon', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'Hôpital du Kremlin Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Roger Salengro, CHRU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Limoges', 'country': 'France', 'facility': 'CHU Dupuytren', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Aachen', 'country': 'Germany', 'facility': 'Universitätsklinikum der Rheinisch-Westfälische Technische Hochschule Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Campus Virchow Klinikum Charité Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Cologne', 'country': 'Germany', 'facility': 'Kliniken der Stadt Köln gGmbH Krankenhaus Merheim', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Franfurt', 'country': 'Germany', 'facility': 'Klinikum der J.-W.-Goethe-Universität Frankfurt a.M.'}, {'city': 'Ludwigshafen', 'country': 'Germany', 'facility': 'BG Klinik Ludwigshafen', 'geoPoint': {'lat': 47.81663, 'lon': 9.06138}}, {'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka University Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Health Care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Organization, Hadassah University Hospital, Ein-Karem', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland City Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital Ullevaal', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Alberton', 'country': 'South Africa', 'facility': 'Netcare Union Hospital', 'geoPoint': {'lat': -26.26786, 'lon': 28.12225}}, {'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Vincent Palotti Dr Christiaan Barnard Memorial Hospital', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Charlotte Maxeke Johannesburg Academic Hospita', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Netcare Milpark Hospital', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Soweto', 'country': 'South Africa', 'facility': 'Chris Hani Baragwanath Hospital', 'geoPoint': {'lat': -26.26781, 'lon': 27.85849}}, {'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'CHU Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'UniversitätsSpital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'The Royal London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Karim Brohi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Royal London Hospital'}, {'name': 'Frank V. Booth, BCh, FACS', 'role': 'STUDY_CHAIR', 'affiliation': 'Sangart, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sangart', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}