Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-02-20 @ 6:03 PM
Study NCT ID:
NCT03797495
Status:
RECRUITING
Last Update Posted:
2025-08-28
First Post:
2018-12-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Individuals Affected With Hypoplasminogenemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C580017', 'term': 'Congenital Plasminogen Deficiency'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood, serum, and plasma will be retained. Time perspective is retrospective and prospective.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-04-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2018-12-28', 'studyFirstSubmitQcDate': '2019-01-08', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Define the natural history of plasminogen deficiency', 'timeFrame': '2 years', 'description': '1. Recruit 100 subjects with hypoplasminogenemia and their first-degree family members\n2. Collect up to 1 year retrospective and 3 year prospective data on symptoms, treatment and interventions'}, {'measure': 'Identify factors that contribute to or correlate with disease expression and severity', 'timeFrame': '5 years', 'description': '1. Perform centralized plasminogen activity and antigen analyses\n2. Perform centralized genetic analysis to identify changes in the plasminogen gene\n3. Perform centralized analysis of polymorphisms that affect plasminogen activity levels and impact fibrinolysis\n4. Perform local urine analysis\n5. Collect samples to explore the interaction of altered plasminogen proteins with bacterial strains'}, {'measure': 'Create a specimen biobank', 'timeFrame': '15 years', 'description': 'Bank plasma, serum and DNA on consenting enrolled subjects'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Plasminogen Deficiency']}, 'referencesModule': {'references': [{'pmid': '1455395', 'type': 'BACKGROUND', 'citation': 'Tait RC, Walker ID, Conkie JA, Islam SI, McCall F, Mitchell R, Davidson JF. Plasminogen levels in healthy volunteers--influence of age, sex, smoking and oral contraceptives. Thromb Haemost. 1992 Nov 10;68(5):506-10.'}, {'pmid': '17900274', 'type': 'BACKGROUND', 'citation': 'Schuster V, Hugle B, Tefs K. Plasminogen deficiency. J Thromb Haemost. 2007 Dec;5(12):2315-22. doi: 10.1111/j.1538-7836.2007.02776.x. Epub 2007 Sep 26.'}, {'pmid': '25208887', 'type': 'BACKGROUND', 'citation': 'Ma Q, Ozel AB, Ramdas S, McGee B, Khoriaty R, Siemieniak D, Li HD, Guan Y, Brody LC, Mills JL, Molloy AM, Ginsburg D, Li JZ, Desch KC. Genetic variants in PLG, LPA, and SIGLEC 14 as well as smoking contribute to plasma plasminogen levels. Blood. 2014 Nov 13;124(20):3155-64. doi: 10.1182/blood-2014-03-560086. Epub 2014 Sep 10.'}, {'pmid': '27629020', 'type': 'BACKGROUND', 'citation': 'Celkan T. Plasminogen deficiency. J Thromb Thrombolysis. 2017 Jan;43(1):132-138. doi: 10.1007/s11239-016-1416-6.'}, {'pmid': '29321155', 'type': 'BACKGROUND', 'citation': 'Shapiro AD, Nakar C, Parker JM, Albert GR, Moran JE, Thibaudeau K, Thukral N, Hardesty BM, Laurin P, Sandset PM. Plasminogen replacement therapy for the treatment of children and adults with congenital plasminogen deficiency. Blood. 2018 Mar 22;131(12):1301-1310. doi: 10.1182/blood-2017-09-806729. Epub 2018 Jan 10.'}, {'pmid': '32001536', 'type': 'BACKGROUND', 'citation': 'Shapiro AD, Menegatti M, Palla R, Boscarino M, Roberson C, Lanzi P, Bowen J, Nakar C, Janson IA, Peyvandi F. An international registry of patients with plasminogen deficiency (HISTORY). Haematologica. 2020 Mar;105(3):554-561. doi: 10.3324/haematol.2019.241158. Epub 2020 Jan 30.'}, {'pmid': '40403316', 'type': 'DERIVED', 'citation': 'Sang Y, Menegatti M, Brody JA, Wiggins KL, Cooley BC, Kapfer KN, Kangro K, de Laat B, Peyvandi F, Flick MJ, Smith NL, Shapiro AD, Wolberg AS. Plasminogen activation and plasmin activity are not necessary to prevent venous thrombosis/thromboembolism. Blood. 2025 Sep 11;146(11):1346-1358. doi: 10.1182/blood.2025028680.'}]}, 'descriptionModule': {'briefSummary': 'This is an Investigator initiated retrospective and prospective single cohort study. The study will utilize an international registry and develop a specimen biobank to provide an improved understanding of the natural history of hyposplasminogenemia, to elucidate the heterogeneity of phenotypic expression, identify markers to predict disease course, and inform improved therapeutic modalities', 'detailedDescription': "The aims of this study are to:\n\n1. Define PLGD natural history in a large cohort of individuals with hypoplasminogenemia and their first-degree family members.\n2. Identify factors that correlate with disease expression and severity.\n3. Create a specimen biobank for further studies, available to other researchers.\n\nThe project will be international in scope with two collaborating centers that have created and will collect the subject data and samples. In North/Central/South America, the Indiana Hemophilia \\& Thrombosis Center (IHTC) will serve as the primary site while University of Milan will serve as the center for all other sites. The database is housed at the University of Milan, Italy.\n\nStudy population will include males and females affected with hyposplasminogenemia of any age. Both one-year retrospective and three-year prospective data will be collected on an international cohort of 100 affected individuals and their first degree family members (parents, siblings; total estimated study population \\~500).\n\nStudy sample analysis, except for urine analyses, will be centralized and performed in Italy; the plasminogen antibody analysis will be batched for analysis, and the urine analyses will be performed locally. A sample biorepository will be created and ultimately housed in Italy. The study will provide testing for plasminogen activity and antigen, plasminogen genetic analysis, polymorphisms in genes that impact plasminogen expression and fibrinolysis, and global hemostatic assays. In addition, stored samples will be used for further testing and analyses to potentially include whole genome sequencing to further identify plasminogen genetic mutations as needed and to investigate other genetic modifiers of disease expression. An exploratory aim includes investigating the potential relationship with streptococcal strains and altered plasminogen products.\n\nThe study period will be 3 years for each enrolled subject. In-person visits will be conducted and samples for analysis will be collected at baseline and at end of study. Interval follow-up will be performed every 6 months by telephone. data will be collected at unscheduled visits that are performed for clinical need at the treating physician's discretion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study population will include males and females affected with hyposplasminogenemia of any age and their first degree family members (siblings and parents).', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Signed informed consent and assent as applicable (Appendix 1)\n2. A. Males or females with type 1 PD diagnosed locally with plasminogen activity levels \\<50% OR B. First degree family members of a person diagnosed with type 1 PD (includes parents, siblings, half-siblings)\n3. All ages included\n4. Available clinical history and treatment for at least 1 year prior to entry except for infants \\< 1 year of age\n5. Willingness to provide samples for analysis including DNA, plasma etc.\n6. Willingness to participate in prospective follow-up for up to 3 years\n\nExclusion Criteria:\n\n1. Previous organ transplant recipient\n2. Any psychiatric disorder, other mental disorder, or any other medical disorder that impairs the subject's ability to give informed consent or to comply with the requirements of the study protocol\n3. Refuses to provide informed consent\n4. Special patient populations, including prisoners or, are deemed medically or cognitively unsuitable for research by their treating physician\n5. Inability to obtain a blood sample due to poor or limited venous access"}, 'identificationModule': {'nctId': 'NCT03797495', 'acronym': 'HISTORY', 'briefTitle': 'Study of Individuals Affected With Hypoplasminogenemia', 'organization': {'class': 'OTHER', 'fullName': 'Indiana Hemophilia &Thrombosis Center, Inc.'}, 'officialTitle': 'Hypoplasminogenemia: An International RetroSpecTive and PrOspective CohoRt StudY (HISTORY)', 'orgStudyIdInfo': {'id': 'HISTORY'}}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lisa Beatty, RN', 'role': 'CONTACT', 'email': 'lbeatty@uabmc.edu', 'phone': '205-638-2394'}, {'name': 'Sharon Davis', 'role': 'CONTACT', 'email': 'sharonddavis@uabmc.edu'}, {'name': 'Christina Bemrich-Stolz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Alabama (UAB)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mindy Simpson, MD', 'role': 'CONTACT', 'email': 'Mindy_L_Simpson@rush.edu', 'phone': '312-942-3034'}, {'name': 'Brian Jenkins', 'role': 'CONTACT', 'email': 'Brian_H_Jenkins@rush.edu', 'phone': '312-563-1883'}, {'name': 'Mindy Simpson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Neelam Thukral, CCRC', 'role': 'CONTACT', 'email': 'nthukral@ihtc.org', 'phone': '317-871-0000', 'phoneExt': '373'}, {'name': 'Charles Nakar, MD', 'role': 'CONTACT', 'email': 'cnakar@ihtc.org', 'phone': '317-871-0000'}, {'name': 'Amy D Shapiro, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Charles Nakar, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Indiana Hemophila @Thrombosis Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sharon Hwee', 'role': 'CONTACT', 'email': 'hweex001@umn.edu', 'phoneExt': '612.626.3915'}, {'name': 'Kris Beatrez', 'role': 'CONTACT', 'email': 'kbeatrez@umn.edu', 'phone': '612.624.1928'}, {'name': 'Alex Boucher, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Minnesota, Pediatric Hem/Onc & Cancer Survivorship Program', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '11733', 'city': 'East Setauket', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nicole Muhlbauer, MD', 'role': 'CONTACT', 'email': 'Nicole.Muhlbauer@stonybrookmedicine.edu', 'phone': '(631) 444-9016'}, {'name': 'Jessica Mannetta', 'role': 'CONTACT', 'email': 'Jessica.Mannetta@stonybrookmedicine.edu', 'phone': '516-329-7843'}, {'name': 'Nicole Muhlbauer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stony Brook University | Stony Brook Medicine', 'geoPoint': {'lat': 40.94149, 'lon': -73.10594}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Karen Bilynsky, RN', 'role': 'CONTACT', 'email': 'bilynskk@upstate.edu', 'phone': '315-464-7601'}, {'name': 'Andrea Dvorak, MD', 'role': 'CONTACT', 'email': 'DvorakA@upstate.edu', 'phone': '315 464 5294'}, {'name': 'Andrea Dvorak, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SUNY Upstate Medical University, Pediatric Hematology/Oncology', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Madeline G Hicks', 'role': 'CONTACT', 'email': 'mghicks@wakehealth.edu', 'phone': '336-713-3553'}, {'name': 'Joia Johnson', 'role': 'CONTACT', 'email': 'joijohns@wakehealth.edu', 'phone': '336-713-3553'}, {'name': 'Amanda Blair, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Frederico Xavier, MD', 'role': 'CONTACT', 'email': 'fxavier@hmc.psu.edu', 'phone': '412-209-7411'}, {'name': 'Debbie Vehec', 'role': 'CONTACT', 'email': 'dvehec@vitalant.org', 'phone': '412-209-7564'}], 'facility': 'Hemophilia Center of Western Pennsylvania', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'COMPLETED', 'country': 'United States', 'facility': "Vanderbilt Children's Hematology-Oncology", 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '76104', 'city': 'Forth Worth', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Heather Urbanek', 'role': 'CONTACT', 'email': 'Heather.Urbanek@cookchildrens.org', 'phone': '682-885-1244'}, {'name': 'Marcela Torres, MD', 'role': 'CONTACT', 'email': 'marcela.torres@cookchildrens.org', 'phone': '682 885 4007'}, {'name': 'Marcela Torres, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Cook Children's Medical Center"}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98105-3901', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gavin Roach, MD', 'role': 'CONTACT', 'email': 'Gavin.Roach@seattlechildrens.org', 'phone': '206-884-1018'}, {'name': 'Shana Tang', 'role': 'CONTACT', 'email': 'shana.tang@seattlechildrens.org', 'phone': '206-884-1268'}, {'name': 'Gavin Roach, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'C1280', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Jhon A Avila, MD', 'role': 'CONTACT', 'email': 'jaavilar@gmail.com', 'phone': '549 114 187 9723'}, {'name': 'Jose M Ceresetto, MD', 'role': 'CONTACT', 'email': 'jceresetto@intramed.net', 'phone': '541 143 041 081'}, {'name': 'Jose M Ceresetto, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jhon A Avila, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Britanico Buenos Aires', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '3052', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Paul Monagle, MD', 'role': 'CONTACT', 'email': 'paul.monagle@rch.org.au', 'phone': '61 3 9936-6330'}, {'name': 'Jodi Hislop, RN', 'role': 'CONTACT', 'email': 'jodi.hislop@rch.org.au', 'phone': '61 3 9936-6330'}, {'name': 'Paul Monagle, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Murdoch Children's Research Institute, The Royal Children's Hospital", 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': 'QLD 4101', 'city': 'South Brisbane', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Ruby Gander', 'role': 'CONTACT', 'email': 'ruby.gander@health.qld.gov.au', 'phone': '61 7 3068 4142'}, {'name': 'Trang Le', 'role': 'CONTACT', 'email': 'trang.le2@health.qld.gov.au', 'phone': '61 7 3069 7206'}, {'name': 'Sally Campbell, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Health Queensland Hospital and Health Service", 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'zip': 'A-6020', 'city': 'Innsbruck', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Lukas Hackl, MD', 'role': 'CONTACT', 'email': 'lukas-hackl@tirol-kliniken.at', 'phone': '+43-512-504-83144'}, {'name': 'Lukas Hackl, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University of Innsbruck, University Clinic for Pediatrics and Adolescent Medicine', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': 'N8W 1L9', 'city': 'Windsor', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Erica Figgins, MSc', 'role': 'CONTACT', 'email': 'Erica.Figgins@wrh.on.ca', 'phone': '519-254-5577', 'phoneExt': '52300'}, {'name': 'Batul Khumushi, CCRP', 'role': 'CONTACT', 'email': 'Batul.Khumushi@wrh.on.ca', 'phone': '519 254 5577', 'phoneExt': '52899'}, {'name': 'Andrea Cervi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Windsor Regional Hospital', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Valerie Arsenault, MD', 'role': 'CONTACT', 'email': 'valerie.arsenault.med@ssss.gouv.qc.ca', 'phone': '(514) 345-4931', 'phoneExt': '3757'}, {'name': 'Bianka Courcelle', 'role': 'CONTACT', 'email': 'bianka.courcelle.hsj@ssss.gouv.qc.ca', 'phone': '514-345-4931', 'phoneExt': '3757'}, {'name': 'Valerie Arsenault, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Sainte-Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'A0121', 'city': 'Québec', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Marie-Claude Pelland-Marcotte, MD', 'role': 'CONTACT', 'email': 'marie-claude.pelland-marcotte.1@ulaval.ca', 'phone': '14185254444', 'phoneExt': '79029'}, {'name': 'Stéphanie Cyr', 'role': 'CONTACT', 'email': 'stephanie.cyr@crchudequebec.ulaval.ca', 'phone': '418 525-4444', 'phoneExt': '40121'}, {'name': 'Marie-Claude Pelland-Marcotte, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Québec Université Laval', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'SK S7N 0W8', 'city': 'Saskatoon', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Sarah Tehseen, MBBS, MSc. 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