Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT06902558
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess Adverse Events and Effectiveness of IntraVenous Infusions of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016891', 'term': 'Polycystic Kidney, Autosomal Dominant'}], 'ancestors': [{'id': 'D007690', 'term': 'Polycystic Kidney Diseases'}, {'id': 'D052177', 'term': 'Kidney Diseases, Cystic'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D000072661', 'term': 'Ciliopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, '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': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2025-03-25', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV)', 'timeFrame': 'Week 96', 'description': 'TKV will be determined from manual contours of the kidneys on 3D magnetic resonance imaging (MRI), performed by imaging specialists and verified by independent radiologists with expertise in Autosomal Dominant Polycystic Kidney Disease (ADPKD).'}, {'measure': 'Number of Participants with Adverse Events (AEs)', 'timeFrame': 'Up to approximately 118 weeks', 'description': 'An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.'}], 'secondaryOutcomes': [{'measure': 'Absolute Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline', 'timeFrame': 'Week 96', 'description': 'eGFR will be measured using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine equation (2021) and CKD-EPI Creatinine-Cystatin equation (2021).'}, {'measure': 'Cumulative Rate of Change from Baseline in Total Kidney Volume (TKV)', 'timeFrame': 'Week 48', 'description': 'TKV will be determined from manual contours of the kidneys on 3D magnetic resonance imaging (MRI), performed by imaging specialists and verified by independent radiologists with expertise in Autosomal Dominant Polycystic Kidney Disease (ADPKD).'}, {'measure': 'Absolute Change in eGFR From Baseline', 'timeFrame': 'Week 48', 'description': 'eGFR will be measured using the CKD-EPI Creatinine equation (2021) and CKD-EPI Creatinine-Cystatin equation (2021).'}, {'measure': 'Time From Randomization to the First Occurrence of Clinical Progression to End-Stage Kidney Disease (ESKD) or >= 40% Decline in eGFR', 'timeFrame': 'Up to Week 96', 'description': 'Defined as initiation of renal replacement therapy (RRT) or kidney transplantation, or a confirmed decline in eGFR of 40% or more from baseline, sustained for at least 4 weeks.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autosomal Dominant Polycystic Kidney Disease (ADPKD)', 'ABBV-CLS-628'], 'conditions': ['Autosomal Dominant Polycystic Kidney Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M25-147', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common genetic cause of kidney disease that causes fluid-filled cysts to develop in the kidneys. The purpose of this study is to assess the safety and efficacy of ABBV-CLS-628 for the treatment of ADPKD in adult participants.\n\nABBV-CLS-628 is an investigational drug being developed for the treatment of ADPKD. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Around 240 adult participants with ADPKD will be enrolled at approximately 100 sites worldwide.\n\nParticipants will receive IntraVenous ABBV-CLS-628 or placebo every 4 weeks for 92 weeks. Participants will be followed for up to 15 weeks.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Autosomal Dominant Polycystic Kidney Disease (ADPKD) Class 1C, 1D, or 1E based on the Mayo Clinic Imaging Classification of ADPKD.\n* Estimated glomerular filtration rate (eGFR) \\>= 30 mL/min/1.73 m\\^2 and \\< 90 mL/min/1.73 m\\^2, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening.\n\nExclusion Criteria:\n\n* Current interventions to treat ADPKD such as non-approved medications or lifestyle modifications.\n* Any exclusionary medical diseases, disorders, or conditions as described in the protocol.'}, 'identificationModule': {'nctId': 'NCT06902558', 'acronym': 'ANCHOR', 'briefTitle': 'A Study to Assess Adverse Events and Effectiveness of IntraVenous Infusions of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ABBV-CLS-628 in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)', 'orgStudyIdInfo': {'id': 'M25-147'}, 'secondaryIdInfos': [{'id': '2024-517143-31-00', 'type': 'OTHER', 'domain': 'EU CT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABBV-CLS-628 Dose A', 'description': 'Participants will receive ABBV-CLS-628 Dose A every 4 weeks for 92 weeks.', 'interventionNames': ['Drug: ABBV-CLS-628']}, {'type': 'EXPERIMENTAL', 'label': 'ABBV-CLS-628 Dose B', 'description': 'Participants will receive ABBV-CLS-628 Dose B every 4 weeks for 92 weeks.', 'interventionNames': ['Drug: ABBV-CLS-628']}, {'type': 'EXPERIMENTAL', 'label': 'ABBV-CLS-628 Dose C', 'description': 'Participants will receive ABBV-CLS-628 Dose C every 4 weeks for 92 weeks.', 'interventionNames': ['Drug: ABBV-CLS-628']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive ABBV-CLS-628 Placebo every 4 weeks for 92 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ABBV-CLS-628', 'type': 'DRUG', 'description': 'IntraVenous Infusion', 'armGroupLabels': ['ABBV-CLS-628 Dose A', 'ABBV-CLS-628 Dose B', 'ABBV-CLS-628 Dose C']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'IntraVenous Infusion', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92844', 'city': 'Garden Grove', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Coordinator', 'role': 'CONTACT', 'phone': '(909) 206-2454'}], 'facility': 'National Institute of Clinical Research - Garden Grove /ID# 271418', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '90255', 'city': 'Huntington Park', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Valiance Clinical Research - Huntington Park /ID# 270634', 'geoPoint': {'lat': 33.98168, 'lon': -118.22507}}, {'zip': '90022', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Academic Medical Research Institute - Los Angeles /ID# 270502', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868-3201', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UC Irvine Medical Center /ID# 270811', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Yale University School of Medicine /ID# 270675', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Horizon Research Group - Coral Gables /ID# 270857', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33313', 'city': 'Fort Lauderdale', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'South Florida Research Institute /ID# 270848', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '34452-4717', 'city': 'Inverness', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Nature Coast Clinical Research - Inverness /ID# 270875', 'geoPoint': {'lat': 28.83582, 'lon': -82.33037}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic Hospital Jacksonville /ID# 271011', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33014', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Panax Clinical Research /ID# 270851', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '83706', 'city': 'Boise', 'state': 'Idaho', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'CARE-Boise Kidney /ID# 270628', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'CARE Institute - Idaho Falls /ID# 272005', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '60611-2927', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Northwestern University Feinberg School of Medicine /ID# 271409', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Kansas Medical Center /ID# 271946', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '02111-1552', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Tufts Medical Center /ID# 270323', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109-5000', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University Of Michigan /ID# 270436', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48315', 'city': 'Shelby', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'St. Clair Nephrology /ID# 271445', 'geoPoint': {'lat': 42.67087, 'lon': -83.03298}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic Hospital Rochester /ID# 270428', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Washington University /ID# 271436', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai /ID# 271440', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Brookview Hills Research Associates /ID# 271449', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '18017', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Northeast Clinical Research Center /ID# 270838', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Nephrology Associates - Chattanooga - East Third Street /ID# 270701', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37923', 'city': 'Knoxville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Knoxville Kidney Center /ID# 270706', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '76015', 'city': 'Arlington', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Arlington Nephrology /ID# 270494', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Renal Disease Research Institute /ID# 270339', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Swedish Medical Center - Seattle /ID# 270344', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Westmead Hospital /ID# 271156', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '4029', 'city': 'Brisbane', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'facility': "Royal Brisbane and Women's Hospital /ID# 271224", 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital /ID# 273114', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '6150', 'city': 'Murdoch', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Fiona Stanley Hospital /ID# 271173', 'geoPoint': {'lat': -32.06987, 'lon': 115.83757}}, {'zip': '1200', 'city': 'Brussels', 'state': 'Brussels Capital', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'Cliniques Universitaires UCL Saint-Luc /ID# 270635', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'UZ Leuven /ID# 270638', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'CHU de Liege /ID# 270631', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '69003', 'city': 'Lyon', 'state': 'Auvergne-Rhône-Alpes', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hopital Edouard Herriot /ID# 271142', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '29200', 'city': 'Brest', 'state': 'Brittany Region', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU Brest - Hôpital de la Cavale Blanche /ID# 271114', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '31400', 'city': 'Toulouse', 'state': 'Occitanie', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU Toulouse - Hôpital Rangueil /ID# 271138', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '13005', 'city': 'Marseille', 'state': "Provence-Alpes-Côte d'Azur Region", 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hopital de la Conception /ID# 271152', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '30625', 'city': 'Hanover', 'state': 'Lower Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover /ID# 270938', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '50937', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Universitaetsklinikum Koeln /ID# 270937', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '10117', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 270935', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '00161', 'city': 'Rome', 'state': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 271563', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '060-8648', 'city': 'Sapporo', 'state': 'Hokkaido', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Hokkaido University Hospital /ID# 271385', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '612-8555', 'city': 'Kyoto', 'state': 'Kyoto', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'National Hospital Organization Kyoto Medical Center /ID# 271782', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '113-8431', 'city': 'Bunkyo-ku', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Juntendo University Hospital /ID# 271722'}, {'zip': '260-8712', 'city': 'Chiba', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'National Hospital Org Chiba Medical Center Chibahigashi National Hospital /ID# 272022', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '3318 AT', 'city': 'Dordrecht', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Albert Schweitzer Ziekenhuis, locatie Dordwijk /ID# 271247', 'geoPoint': {'lat': 51.81, 'lon': 4.67361}}, {'zip': '9713 GR', 'city': 'Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum Groningen /ID# 271249', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '2805-267', 'city': 'Almada', 'state': 'Setúbal District', 'status': 'RECRUITING', 'country': 'Portugal', 'facility': 'Unidade Local de Saude de Almada-Seixal, EPE /ID# 271257', 'geoPoint': {'lat': 38.67902, 'lon': -9.1569}}, {'zip': '4710-243', 'city': 'Braga', 'status': 'RECRUITING', 'country': 'Portugal', 'facility': '2CA-Braga, Hospital de Braga /ID# 271258', 'geoPoint': {'lat': 41.5514, 'lon': -8.42311}}, {'zip': '8000-386', 'city': 'Faro', 'status': 'RECRUITING', 'country': 'Portugal', 'facility': 'Unidade Local de Saude do Algarve, EPE /ID# 271819', 'geoPoint': {'lat': 37.01869, 'lon': -7.92716}}, {'zip': '1150-199', 'city': 'Lisbon', 'status': 'RECRUITING', 'country': 'Portugal', 'facility': 'Unidade Local de Saude de Sao Jose, EPE /ID# 271255', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '1449-005', 'city': 'Lisbon', 'status': 'RECRUITING', 'country': 'Portugal', 'facility': 'Unidade Local de Saude de Lisboa Ocidental, EPE /ID# 271261', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '49241', 'city': 'Busan', 'state': 'Busan Gwang Yeogsi', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Pusan National University Hospital /ID# 271429', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '42601', 'city': 'Daegu', 'state': 'Gyeongsangbuk-do', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Hospital /ID# 272455'}, {'zip': '03080', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Seoul National University Hospital /ID# 271331', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07061', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'SMG-SNU Boramae Medical Center /ID# 271227', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07441', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Hallym University Kangnam Sacred Heart Hospital /ID# 271329', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Site Coordinator', 'role': 'CONTACT', 'phone': '+34 93 260 71 13'}], 'facility': 'Hospital Universitari de Bellvitge /ID# 270489', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '08025', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Fundacio Puigvert /ID# 270491', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '18014', 'city': 'Granada', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de las Nieves /ID# 270918', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '28040', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Fundacion Jimenez Diaz /ID# 270485', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Site Coordinator', 'role': 'CONTACT', 'phone': '913 90 80 00'}], 'facility': 'Hospital Universitario 12 de Octubre /ID# 270829', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46010', 'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valencia /ID# 270837', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'centralContacts': [{'name': 'ABBVIE CALL CENTER', 'role': 'CONTACT', 'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '844-663-3742'}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/abbvie/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.', 'accessCriteria': 'To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Calico Life Sciences LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}