Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-03 @ 8:42 PM
Study NCT ID:
NCT04146935
Status:
COMPLETED
Last Update Posted:
2023-08-24
First Post:
2019-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Examining the Effect of Burosumab on Muscle Function
Sponsor:
Organization:
Raw JSON
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Dose may be adjusted as needed.\n\nBurosumab Injection \\[Crysvita\\]: Burosumab/Crysvita SC injection monthly', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Partial ureteropelvic junction obstruction by staghorn calculus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Skeletal Muscle Adenosine Triphosphate (ATP) Synthesis Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With XLH', 'description': 'Patients will receive Burosumab monthly at visits 1,2 and 3 subcutaneously at a dose of 1.0 mg/kg. Dose may be adjusted as needed.\n\nBurosumab Injection \\[Crysvita\\]: Burosumab/Crysvita SC injection monthly'}], 'classes': [{'categories': [{'measurements': [{'value': '9.41', 'groupId': 'OG000', 'lowerLimit': '8.7827', 'upperLimit': '10.0333'}]}]}], 'analyses': [{'pValue': '0.4147', 'groupIds': ['OG000'], 'pValueComment': 'Visit 1 (baseline) to visit 4 (peak)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Mixed model repeated measures'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2.5 months', 'description': 'Rates of mitochondrial phosphorylation activity were assessed in the soleus/gastrocnemius muscle complex of the right calf by 31P magnetic resonance spectroscopy saturation transfer technique (micro-mol/g/min)', 'unitOfMeasure': 'umol/g/min', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Phosphate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With XLH', 'description': 'Patients will receive Burosumab monthly at visits 1,2 and 3 subcutaneously at a dose of 1.0 mg/kg. Dose may be adjusted as needed.\n\nBurosumab Injection \\[Crysvita\\]: Burosumab/Crysvita SC injection monthly'}], 'classes': [{'categories': [{'measurements': [{'value': '2.85', 'groupId': 'OG000', 'lowerLimit': '2.4231', 'upperLimit': '3.2769'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2.5 months', 'description': 'measured in mg/dl', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intracellular Phosphate Concentration in Umol/g Muscle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With XLH', 'description': 'Patients will receive Burosumab monthly at visits 1,2 and 3 subcutaneously at a dose of 1.0 mg/kg. Dose may be adjusted as needed.\n\nBurosumab Injection \\[Crysvita\\]: Burosumab/Crysvita SC injection monthly'}], 'classes': [{'categories': [{'measurements': [{'value': '2.31', 'groupId': 'OG000', 'lowerLimit': '1.9654', 'upperLimit': '2.6446'}]}]}], 'analyses': [{'pValue': '0.6957', 'groupIds': ['OG000'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Mixed model repeated measures'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2.5 months', 'description': 'Intracellular phosphorus concentration in skeletal muscle (umol/g muscle)', 'unitOfMeasure': 'umol/g muscle', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Six-minute Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With XLH', 'description': 'Patients will receive Burosumab monthly at visits 1,2 and 3 subcutaneously at a dose of 1.0 mg/kg. Dose may be adjusted as needed.\n\nBurosumab Injection \\[Crysvita\\]: Burosumab/Crysvita SC injection monthly'}], 'classes': [{'categories': [{'measurements': [{'value': '440.4', 'groupId': 'OG000', 'lowerLimit': '388.06', 'upperLimit': '492.74'}]}]}], 'analyses': [{'pValue': '0.0092', 'groupIds': ['OG000'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2.5 months', 'description': 'functional testing outcome measured in meters', 'unitOfMeasure': 'meter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Sit to Stand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With XLH', 'description': 'Patients will receive Burosumab monthly at visits 1,2 and 3 subcutaneously at a dose of 1.0 mg/kg. Dose may be adjusted as needed.\n\nBurosumab Injection \\[Crysvita\\]: Burosumab/Crysvita SC injection monthly'}], 'classes': [{'categories': [{'measurements': [{'value': '14.2', 'groupId': 'OG000', 'lowerLimit': '10.8312', 'upperLimit': '17.5688'}]}]}], 'analyses': [{'pValue': '0.1383', 'groupIds': ['OG000'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Mixed model repeated measures'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2.5 months', 'description': 'functional testing outcome measured in the number completed in 30 seconds', 'unitOfMeasure': 'repetitions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Timed up and go Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With XLH', 'description': 'Patients will receive Burosumab monthly at visits 1,2 and 3 subcutaneously at a dose of 1.0 mg/kg. Dose may be adjusted as needed.\n\nBurosumab Injection \\[Crysvita\\]: Burosumab/Crysvita SC injection monthly'}], 'classes': [{'categories': [{'measurements': [{'value': '7.47', 'groupId': 'OG000', 'lowerLimit': '6.4473', 'upperLimit': '8.4967'}]}]}], 'analyses': [{'pValue': '0.0572', 'groupIds': ['OG000'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'mixed model repeated measures'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2.5 months', 'description': 'functional testing outcome measured in seconds', 'unitOfMeasure': 'second', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients With XLH', 'description': 'Patients will receive Burosumab monthly at visits 1,2 and 3 subcutaneously at a dose of 1.0 mg/kg. Dose may be adjusted as needed.\n\nBurosumab Injection \\[Crysvita\\]: Burosumab/Crysvita SC injection monthly'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients With XLH', 'description': 'Patients will receive Burosumab monthly at visits 1,2 and 3 subcutaneously at a dose of 1.0 mg/kg. Dose may be adjusted as needed.\n\nBurosumab Injection \\[Crysvita\\]: Burosumab/Crysvita SC injection monthly'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.7', 'spread': '11.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fasting serum phosphate', 'classes': [{'categories': [{'measurements': [{'value': '1.74', 'spread': '0.43', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Serum calcium', 'classes': [{'categories': [{'measurements': [{'value': '9.30', 'spread': '0.32', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Parathyroid hormone (PTH)', 'classes': [{'categories': [{'measurements': [{'value': '68.78', 'spread': '24.40', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Renal phosphate threshold', 'classes': [{'categories': [{'measurements': [{'value': '1.59', 'spread': '0.44', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/100 ml GF', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fibroblast growth factor (FGF) 23 levels', 'classes': [{'categories': [{'measurements': [{'value': '53.4', 'spread': '14.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '25-hydroxy vitamin D', 'classes': [{'categories': [{'measurements': [{'value': '34.23', 'spread': '15.53', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '1,25-dihydroxy vitamin D', 'classes': [{'categories': [{'measurements': [{'value': '71.29', 'spread': '19.05', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Serum creatinine', 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'spread': '0.15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-04', 'size': 325020, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-05T09:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-22', 'studyFirstSubmitDate': '2019-10-29', 'resultsFirstSubmitDate': '2023-07-27', 'studyFirstSubmitQcDate': '2019-10-29', 'lastUpdatePostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-22', 'studyFirstPostDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Six-minute Walk Test', 'timeFrame': '2.5 months', 'description': 'functional testing outcome measured in meters'}, {'measure': 'Sit to Stand', 'timeFrame': '2.5 months', 'description': 'functional testing outcome measured in the number completed in 30 seconds'}, {'measure': 'Timed up and go Test', 'timeFrame': '2.5 months', 'description': 'functional testing outcome measured in seconds'}], 'primaryOutcomes': [{'measure': 'Skeletal Muscle Adenosine Triphosphate (ATP) Synthesis Rate', 'timeFrame': '2.5 months', 'description': 'Rates of mitochondrial phosphorylation activity were assessed in the soleus/gastrocnemius muscle complex of the right calf by 31P magnetic resonance spectroscopy saturation transfer technique (micro-mol/g/min)'}], 'secondaryOutcomes': [{'measure': 'Serum Phosphate', 'timeFrame': '2.5 months', 'description': 'measured in mg/dl'}, {'measure': 'Intracellular Phosphate Concentration in Umol/g Muscle', 'timeFrame': '2.5 months', 'description': 'Intracellular phosphorus concentration in skeletal muscle (umol/g muscle)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Crysvita', 'Burosumab'], 'conditions': ['X-linked Hypophosphatemia']}, 'referencesModule': {'references': [{'pmid': '27338702', 'type': 'BACKGROUND', 'citation': 'Pesta DH, Tsirigotis DN, Befroy DE, Caballero D, Jurczak MJ, Rahimi Y, Cline GW, Dufour S, Birkenfeld AL, Rothman DL, Carpenter TO, Insogna K, Petersen KF, Bergwitz C, Shulman GI. Hypophosphatemia promotes lower rates of muscle ATP synthesis. FASEB J. 2016 Oct;30(10):3378-3387. doi: 10.1096/fj.201600473R. Epub 2016 Jun 23.'}]}, 'descriptionModule': {'briefSummary': 'Patients with X-linked hypophosphatemia (XLH) often report symptoms of fatigue and weakness particularly after exertion, in addition to their skeletal complaints. In previous trials using KRN23 (same drug as burosumab/Crysvita®), patients report these symptoms improve. The investigators wish to test this hypothesis directly by measuring muscle energy when patients begin treatment with Crysvita® for the first time.', 'detailedDescription': 'X-linked hypophosphatemia is a skeletal dysplasia. The mineralized tissue complications of XLH have been the focus of investigative studies seeking to understand its pathogenesis, as well as studies directed at new therapies. However, in addition to their skeletal complaints, patients with XLH have among their most frequent symptoms, fatigue and weakness, which manifest as both a generalized sense of a lack of energy as well as a more specific feeling that their muscular function is impaired. Objectively, patients complain of fatigue after exertion, when otherwise they do not think they should expect to feel so spent. These symptoms occur in individuals who otherwise have good cardiovascular and respiratory health, so co-morbidities are unlikely to explain these pervasive complaints. Anecdotally, the investigators open-label trial data using KRN23 suggest that these symptoms are dramatically ameliorated by treatment with the drug. In a recent study¹, the investigators found that when stressed by a low-phosphate diet, rates of insulin-stimulated myocyte Adenosine triphosphate (ATP) flux were reduced by 50% in an experimental model of systemic hypophosphatemia (the NaPi2a knockout mouse). Moreover, ATP synthetic flux correlated directly with cellular and mitochondrial phosphate uptake in two rodent myocyte cell lines, as well as in freshly isolated myocyte mitochondria. As direct evidence that these preclinical findings are relevant to human hypophosphatemic genetic syndromes we studied a patient with Heredity Hypophosphatemic Rickets with Hypercalciuria (HHRH) who was not being treated at the time of our experiment. In this patient who had a 50% reduction in serum phosphate, muscle ATP content was also significantly reduced ¹. Both of these parameters normalized completely with oral phosphate repletion ¹. These data strongly support the hypothesis that reduced muscle ATP flux may underlie the myopathy seen in patients with XLH. The investigators propose to directly test this hypothesis, in patients about to begin treatment with Crysvita® for the first time.\n\nMuscle tissue phosphorus concentration and ATP flux rates will be assessed in the right gastrocnemius of the lower leg using 31P-NMR (nuclear magnetic resonance) spectroscopy over the course of the 3 month study. The study consists of 5 visits total over 3 months. At visits 1,4 and 5, patients will undergo magnetic resonance (MR) spectroscopy assessments and functional testing along with blood and urine analysis. At visits 1,2 and 3 patients will receive Burosumab/Crysvita® by subcutaneous injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 18-65 years of age\n2. Diagnosis of XLH\n3. eGFR ≥ 50 (estimated glomerular filtration rate)\n4. Normal serum calcium\n5. Phosphate ≤ 2.5 mg/dl\n6. Deemed clinically appropriate for starting therapy with Burosumab/Crysvita® (based on the treating physician's evaluation)\n7. Deemed appropriate for MR Spectroscopy\n\nExclusion Criteria:\n\n1. Patients with fixed skeletal abnormalities which would prevent them from successfully completing study-related functional assessments\n2. Patients unwilling to stop therapy with supplemental phosphate and calcitriol 2 weeks prior to enrollment.\n3. Patients who have undergone an orthopaedic procedure within the previous 6 months involving implantation of metal hardware"}, 'identificationModule': {'nctId': 'NCT04146935', 'briefTitle': 'Examining the Effect of Burosumab on Muscle Function', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Examining the Effect of Burosumab on Muscle Function Using MR Spectroscopy', 'orgStudyIdInfo': {'id': '2000026400'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with XLH', 'description': 'Patients will receive Burosumab monthly at visits 1,2 and 3 subcutaneously at a dose of 1.0 mg/kg. Dose may be adjusted as needed.', 'interventionNames': ['Drug: Burosumab Injection [Crysvita]']}], 'interventions': [{'name': 'Burosumab Injection [Crysvita]', 'type': 'DRUG', 'otherNames': ['Crysvita'], 'description': 'Burosumab/Crysvita SC injection monthly', 'armGroupLabels': ['Patients with XLH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Karl L Insogna, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}