Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-01-03 @ 9:36 AM
Study NCT ID:
NCT04159103
Status:
RECRUITING
Last Update Posted:
2025-10-31
First Post:
2019-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-Label Study of mRNA-3927 in Participants With Propionic Acidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056693', 'term': 'Propionic Acidemia'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D000592', 'term': 'Amino Acid Metabolism, Inborn Errors'}, {'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 77}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-29', 'studyFirstSubmitDate': '2019-11-07', 'studyFirstSubmitQcDate': '2019-11-07', 'lastUpdatePostDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Number of Participants with Treatment-emergent Adverse Event (TEAE), Serious Adverse Events (SAE) and TEAEs Leading to Discontinuation', 'timeFrame': 'Day 1 (initial mRNA-3927 dose) up to Week 150 (End of Study)'}, {'measure': 'Part 2: Change in Annualized Frequency of Clinical Event Committee (CEC)-adjudicated Metabolic Decompensation Events (MDEs) During 12-month Treatment Period With mRNA-3927 Compared to Annualized Frequency of CEC-adjudicated MDE During Pretreatment Period', 'timeFrame': 'Pretreatment period (12 months before consent to first mRNA-3927 dose in the study) up to Month 12'}, {'measure': 'Part 3: Number of Participants with TEAEs, SAEs, Adverse Events (AEs) of Special Interest (AESIs) and TEAEs Leading to Discontinuation', 'timeFrame': 'Day 1 up to Week 73'}], 'secondaryOutcomes': [{'measure': 'Part 1: Change From Baseline in Plasma 2-Methylcitrate (2-MC) and 3-Hydroxypropionic Acid (3-HP) Levels After Single and Repeated Administrations of mRNA-3927', 'timeFrame': 'Baseline up to Week 40', 'description': 'Baseline (predose levels) to postdose levels measured after single and after repeated administrations of mRNA-3927'}, {'measure': 'Part 1: Maximum Observed Effect (Emax) of 2-MC and 3-HP After Single and Repeated Administrations of mRNA-3927', 'timeFrame': 'Baseline up to Week 40', 'description': 'Baseline (predose levels) to postdose levels measured after single and after repeated administrations of mRNA-3927'}, {'measure': 'Part 1: Area Under the Effect Versus Time Curve (AUEC) of 2-MC and 3-HP After Single and Repeated Administrations of mRNA-3927', 'timeFrame': 'Baseline up to Week 40', 'description': 'Baseline (predose levels) to postdose levels measured after single and after repeated administrations of mRNA-3927'}, {'measure': 'Part 1: Duration of Response (DOR) After Single and Repeated Administrations of mRNA-3927', 'timeFrame': 'Baseline up to Week 40', 'description': 'Baseline (predose levels) to postdose levels measured after single and after repeated administrations of mRNA-3927'}, {'measure': 'Part 1: Maximum Observed Concentration (Cmax) of Propionyl-CoA Carboxylase Subunit α (PCCA) and Propionyl-CoA Carboxylase Subunit β (PCCB) mRNAs', 'timeFrame': 'Baseline up to Week 40', 'description': 'Baseline (predose levels) to postdose levels measured after single and after repeated administrations of mRNA-3927'}, {'measure': 'Part 1: Time of Cmax (Tmax) of PCCA and PCCB mRNAs', 'timeFrame': 'Baseline up to Week 40', 'description': 'Baseline (predose levels) to postdose levels measured after single and after repeated administrations of mRNA-3927'}, {'measure': 'Part 1: Area Under the Plasma Concentration-Time Curve (AUC) of PCCA and PCCB mRNAs', 'timeFrame': 'Baseline up to Week 40', 'description': 'Baseline (predose levels) to postdose levels measured after single and after repeated administrations of mRNA-3927'}, {'measure': 'Part 1: SM-86 Concentration After Single and Repeated Administrations of mRNA-3927', 'timeFrame': 'Baseline up to Week 40', 'description': 'Baseline (predose levels) to postdose levels measured after single and after repeated administrations of mRNA-3927'}, {'measure': 'Part 1: Frequency of Anti-Polyethylene Glycol and Anti-Propionyl-CoA Carboxylase Antibodies', 'timeFrame': 'Day 1 (initial mRNA-3927 dose) up to Week 150 (End of Study)'}, {'measure': 'Part 2: Change in Annualized Frequency of CEC-adjudicated MDE-related Hospitalizations During the 12-month Treatment Period With mRNA-3927 Compared to the Annualized Frequency of CEC-adjudicated MDE-related Hospitalizations During the Pretreatment Period', 'timeFrame': 'Pretreatment period (12 months before consent to first mRNA-3927 dose in the study) up to Month 12'}, {'measure': 'Part 2: Change in Annualized Frequency of CEC-adjudicated PA-related Hospitalizations During the 12-month Treatment Period With mRNA-3927 Compared to the Annualized Frequency of CEC-adjudicated PA-related Hospitalizations During the Pretreatment Period', 'timeFrame': 'Pretreatment period (12 months before consent to first mRNA-3927 dose in the study) up to Month 12'}, {'measure': 'Part 2: Change in Annualized Frequency of CEC-adjudicated MDEs During 12-month Treatment Period With mRNA-3927 Compared to Annualized Frequency of CEC-adjudicated MDE During Pretreatment Period by the Following Severity Grades: Grade 1, Grade 2, Grade 3', 'timeFrame': 'Pretreatment period (12 months before consent to first mRNA-3927 dose in the study) up to Month 12'}, {'measure': 'Parts 2 and 3: Change from Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Score and Physical Function Score', 'timeFrame': 'Baseline up to Week 52'}, {'measure': 'Parts 2 and 3: Change from Baseline in Methylmalonic Acidemia and Propionic Acidemia Questionnaire - Proximal Signs and Symptoms (MMAPAQ-PSS) Total Score', 'timeFrame': 'Baseline up to Week 52'}, {'measure': "Parts 2 and 3: Percentage of Participants Distributed into 'Mild', 'Moderate', and 'Severe' Categories Based on Investigator Global Assessment of Severity (IGA-S) Severity Levels", 'timeFrame': 'Baseline up to Week 52'}, {'measure': "Parts 2 and 3: Percentage of Participants Meeting 'Modestly Improved' or 'Much Improved' in Investigator Global Assessment of Improvement (IGA-I)", 'timeFrame': 'Baseline up to Week 52'}, {'measure': 'Part 2: Change in Annualized Frequency of CEC-adjudicated PA-related Urgent Healthcare Encounters During 12-month Treatment Period Compared to Annualized Frequency of CEC-adjudicated PA-related Urgent Healthcare Encounters During Pretreatment Period', 'timeFrame': 'Pretreatment period (12 months before consent to first mRNA-3927 dose in the study) up to Month 12'}, {'measure': 'Parts 2 and 3: Change From Baseline in Plasma 2-MC and 3-HP Levels After Administration of mRNA-3927', 'timeFrame': 'Baseline up to Week 52'}, {'measure': 'Parts 2 and 3: Area That is Below the Baseline and Above the Response Curve (AUC_Below_B) of 2-MC and 3-HP After Administration of mRNA-3927', 'timeFrame': 'Baseline up to Week 52'}, {'measure': 'Parts 2 and 3: Area Under the Curve That is AUC_Above_B - AUC_Below_B (AUC_Net_B) of 2-MC and 3-HP After Administration of mRNA-3927', 'timeFrame': 'Baseline up to Week 52'}, {'measure': 'Parts 2 and 3: Emax of 2-MC and 3-HP After Administration of mRNA-3927', 'timeFrame': 'Baseline up to Week 52'}, {'measure': 'Part 2: Number of Participants with TEAEs, SAEs, AESIs, and TEAEs Leading to Discontinuation', 'timeFrame': 'Day 1 up to Week 73'}, {'measure': 'Part 3: Annualized Frequency of CEC-adjudicated MDEs', 'timeFrame': 'Baseline up to Week 52'}, {'measure': 'Part 3: Annualized Frequency of CEC-adjudicated MDE-related Hospitalizations', 'timeFrame': 'Baseline up to Week 52'}, {'measure': 'Part 3: Annualized Frequency of CEC-adjudicated PA-related Hospitalizations', 'timeFrame': 'Baseline up to Week 52'}, {'measure': 'Part 3: Annualized Frequency of CEC-adjudicated MDEs by the Following MDE Severity Grades: Grade 1, Grade 2, Grade 3', 'timeFrame': 'Baseline up to Week 52'}, {'measure': 'Part 3: Annualized Frequency of CEC-adjudicated PA-related Urgent Healthcare Encounters', 'timeFrame': 'Baseline up to Week 52'}, {'measure': 'Part 3: Cmax of PCCA and PCCB mRNAs', 'timeFrame': 'Baseline up to Week 52'}, {'measure': 'Part 3: Tmax of PCCA and PCCB mRNAs', 'timeFrame': 'Baseline up to Week 52'}, {'measure': 'Part 3: AUC of PCCA and PCCB mRNAs', 'timeFrame': 'Baseline up to Week 52'}, {'measure': 'Part 3: Cmax of SM-86 and OL-56', 'timeFrame': 'Baseline up to Week 52'}, {'measure': 'Part 3: Tmax of SM-86 and OL-56', 'timeFrame': 'Baseline up to Week 52'}, {'measure': 'Part 3: AUC of SM-86 and OL-56', 'timeFrame': 'Baseline up to Week 52'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mRNA-3927', 'Propionic Aciduria', 'Metabolism, Inborn Errors', 'Genetic Diseases', 'Inborn Amino Acid Metabolism, Inborn Errors', 'Acidosis', 'Acid-Base Imbalance', 'Metabolic Diseases', 'Organic Acidemias', 'Moderna', 'mRNA'], 'conditions': ['Propionic Acidemia']}, 'referencesModule': {'references': [{'pmid': '36577040', 'type': 'DERIVED', 'citation': 'Attarwala H, Lumley M, Liang M, Ivaturi V, Senn J. Translational Pharmacokinetic/Pharmacodynamic Model for mRNA-3927, an Investigational Therapeutic for the Treatment of Propionic Acidemia. Nucleic Acid Ther. 2023 Apr;33(2):141-147. doi: 10.1089/nat.2022.0036. Epub 2022 Dec 27.'}]}, 'descriptionModule': {'briefSummary': 'This 3-part, Phase 1/2 study is designed to characterize the safety, tolerability, and pharmacological activity (as assessed by biomarker measurements) and to determine the selected dose of mRNA-3927 in participants with genetically confirmed propionic acidemia (PA). After establishing a dose with an acceptable safety and pharmacodynamic (PD) response for participants ≥1 year of age in Part 1, participants will be enrolled in Part 2 (which will serve as the pivotal study) to allow for determination of the efficacy, safety, and PD of mRNA-3927. Part 3 will evaluate the safety, efficacy and PD response of mRNA-3927 in infants (\\<1 year of age).', 'detailedDescription': 'During the Dose Optimization Stage, after each dose cohort is fully enrolled (≥1 year of age), and the dose-limiting toxicity (DLT) observation window of at least 14 days is complete for the final participant in that cohort, the Sponsor will review the totality of available safety data in conjunction with all available PK/PD data. Based on this review, the Sponsor will recommend a revised dose and/or dosing interval. The Sponsor will abide by predefined constraints as to the maximum percentage change in dose and dose interval. A maximum of 9 cohorts will be enrolled in Part 1 (Dose Optimization).\n\nUpon establishment of a dose with an acceptable safety and PD activity in Part 1 (participants ≥1 year of age), additional participants will be enrolled into the study in Part 2 (participants ≥1 year of age) to allow for determination of the safety, efficacy, and PD of mRNA-3927. Part 3 will evaluate the safety, efficacy and PD response in infants (\\<1 year of age).\n\nParticipants in all the phases will participate in a predosing observational period, followed by a treatment period, and then a follow-up period after withdrawal of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nParticipants ≥1 year of age are eligible to be included in the study only if all of the following criteria apply:\n\n* ≥ 8 years of age at the time of consent/assent if enrolled as 1 of the first 2 participants in Part 1.\n* ≥1 year of age at the time of consent/assent if enrolled after the first 2 participants in Part 1.\n* Confirmed diagnosis of PA based on diagnosis by molecular genetic testing via central laboratory (PCCA and/or PCCB mutations).\n* Part 2 only: At least one documented MDE in the 12-month period before consent.\n\nParticipants \\<1 Year of Age :\n\n* Identification by newborn screening shortly after birth or having suspected PA by presenting with a spectrum of metabolic symptoms, and having a sibling diagnosed with PA. Participant may enter the Screening Period while awaiting genetic testing results, provided that all other eligibility criteria are met but would not be enrolled until diagnosis of PA is confirmed.\n* For infants in the neonatal intensive care unit (NICU) only: ≥37 weeks gestational age at the time of birth without other conditions/comorbidities that in the opinion of the Investigator may interfere with the interpretation of study results.\n* Body weight ≥3 kilograms (kg) at Screening.\n* At least 1 documented PA-related event prior to Screening defined as the following criteria:\n\n * Clinical signs of metabolic deterioration consistent with PA (for example, vomiting, not feeding well/poor suck, heavy breathing, lethargy, absence of proper perfusion, abnormal movements including bicycling, abnormal tone, low body temperature, seizure\\[s\\]), OR\n * Meeting the criteria of MDE definition, OR\n * Evidence of laboratory abnormalities as evidenced by at least one of the following:\n* Metabolic acidosis with elevated anion gap.\n* Acute hyperammonemia.\n* Neutropenia or thrombocytopenia.\n\nExclusion Criteria:\n\nParticipants of all ages are excluded from the study if during Screening any of the following criteria apply:\n\n* Any individual with laboratory abnormalities considered to be clinically significant (for example, markedly out of range, associated with clinical symptoms) in the Investigator or Sponsor's opinion that could interfere with or limit the participation in the study.\n* Estimated glomerular filtration rate (eGFR) \\<30 milliliters (mL)/minute/1.73 square meter (m\\^2) for participants of all ages receiving chronic dialysis.\n* History of organ transplantation or planned organ transplantation during the period of study participation.\n* Corrected QT interval (QTc) \\>480 milliseconds (ms) using Bazett's correction.\n* Grade 3 or 4 heart failure according to the Modified Ross Heart Failure Classification for Children or the New York Heart Association Classification.\n* Pregnant or breastfeeding.\n* Other clinically significant conditions that in the Investigator's opinion could interfere with the safety of the participant, the interpretation of study results, or limit the participation in the study."}, 'identificationModule': {'nctId': 'NCT04159103', 'briefTitle': 'Open-Label Study of mRNA-3927 in Participants With Propionic Acidemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'ModernaTX, Inc.'}, 'officialTitle': 'A Global, Phase 1/2, Open-Label, Dose Optimization Study to Evaluate the Safety, Pharmacodynamics, and Pharmacokinetics of mRNA-3927 in Participants With Propionic Acidemia', 'orgStudyIdInfo': {'id': 'mRNA-3927-P101'}, 'secondaryIdInfos': [{'id': '2022-502910-10-00', 'type': 'OTHER', 'domain': 'Clinical Trials Information System (CTIS)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 (Dose Optimization), Part 2 (Pivotal Study), and Part 3 (Infants)', 'description': 'Part 1 (Dose Optimization): Participants (≥1 year of age) will receive single dose of mRNA-3927 by intravenous (IV) infusion every 2 weeks (Q2W) or every 3 weeks (Q3W) for up to 10 doses.\n\nPart 2 (Pivotal Study): Participants (≥1 year of age) will receive single dose of mRNA-3927 (identified during Dose Optimization Phase) by IV infusion Q2W for up to 26 doses or approximately 12 months. Part 3: Participants (\\<1 year of age) will receive single dose of mRNA-3927 (identified during Dose Optimization Phase) by IV infusion Q2W for up to 26 doses or approximately 12 months.', 'interventionNames': ['Biological: mRNA-3927']}], 'interventions': [{'name': 'mRNA-3927', 'type': 'BIOLOGICAL', 'description': 'mRNA-3927 dispersion for IV infusion', 'armGroupLabels': ['Part 1 (Dose Optimization), Part 2 (Pivotal Study), and Part 3 (Infants)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'UCSD Altman Clinical and Transalational Research Institute Building', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rosemary Silva-Garcia', 'role': 'CONTACT', 'email': 'rsilvagarcia@mednet.ucla.edu'}], 'facility': 'Ronald Reagan UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'hsrobin@stanford.edu', 'phone': '650-497-0454'}], 'facility': "Lucile Packard Children's Hospital Stanford", 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': "Nicklaus Children's Hospital", 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33606-3603', 'city': 'Tampa', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'University of South Florida - 12901 Bruce B Downs', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ann and Robert H Lurie Childrens Hospital of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Johns Hopkins Hospital, Adult Outpatient Clinical Research Unit', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'COMPLETED', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Michigan Hospitals', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai - Clinical Research Unit', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ming Xu', 'role': 'CONTACT', 'email': 'mingfen.xu@duke.edu'}], 'facility': 'Duke University Medical System (Duke Health)', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'COMPLETED', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106-2624', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center - 11100 Euclid Ave', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebecca Madden', 'role': 'CONTACT', 'email': 'maddenr@chop.edu'}], 'facility': "Children's Hospital of Philadelphia (CHOP)", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alyssa Tran', 'role': 'CONTACT', 'email': 'alyssat@bcm.edu'}], 'facility': "Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'T6G 2R7', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Cheri Robert', 'role': 'CONTACT', 'email': 'cheri.robert@albertahealthservices.ca', 'phone': '(780) 248-5611'}, {'name': 'Komudi Siriwardena', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Stollery Children's Hospital University of Alberta", 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Ashley Wilson', 'role': 'CONTACT', 'email': 'ashley.wilson@sickkids.ca'}], 'facility': 'Hospital For Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '13005', 'city': 'Marseille', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'CHU de Marseille - Hôpital de la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '75019', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hôpital Necker - Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '470-1192', 'city': 'Toyoake-shi', 'state': 'Aichi-ken', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'role': 'CONTACT', 'email': 'yonaka@fujita-hu.ac.jp'}, {'name': 'Yoko Nakajima', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fujita Health University Hospital'}, {'zip': '980-8574', 'city': 'Sendai', 'state': 'Miyagi', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'role': 'CONTACT', 'email': 'natsuko.ichinoi.b6@tohoku.ac.jp'}, {'name': 'Natsuko Ichinoi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tohoku University Hospital', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '113-8519', 'city': 'Tokyo', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Japan', 'facility': 'National Center for Child Health and Development', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '3015 GD', 'city': 'Rotterdam', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3584 CX', 'city': 'Utrecht', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum Utrecht - PPDS', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '11211', 'city': 'Riyadh', 'state': 'Ar Riya', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Saudi Arabia', 'facility': 'King Faisal Specialist Hospital & Research Center - Riyadh', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '11564', 'city': 'Riyadh', 'state': 'Ar Riya', 'status': 'NOT_YET_RECRUITING', 'country': 'Saudi Arabia', 'facility': 'King Fahad Medical City', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '14611', 'city': 'Riyadh', 'state': 'Ar Riya', 'status': 'NOT_YET_RECRUITING', 'country': 'Saudi Arabia', 'facility': "King Abdullah Children's Specialist Hospital", 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'zip': '8950', 'city': 'Esplugues de Llobregat', 'state': 'Barcelona', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Spain', 'facility': 'Hospital Sant Joan de Deu - PIN', 'geoPoint': {'lat': 41.37732, 'lon': 2.08809}}, {'zip': '48903', 'city': 'Barakaldo', 'state': 'Biscay', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Cruces', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}, {'zip': '28041', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '41013', 'city': 'Seville', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocio - PPDS', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': 'B15 2TH', 'city': 'Birmingham', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Vishy Veeranna', 'role': 'CONTACT', 'email': 'Vishy.veeranna@uhb.nhs.uk'}], 'facility': 'University Hospital Birmingham NHS Foundation Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'B4 6NH', 'city': 'Birmingham', 'status': 'COMPLETED', 'country': 'United Kingdom', 'facility': "Birmingham Children's Hospital", 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'WC1N 3JH', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'role': 'CONTACT', 'email': 'Stephanie.Grunewald@gosh.nhs.uk'}, {'name': 'Stephanie Grunewald', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Great Ormond Street Hospital for Children NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Willink Biochemical Genetics Unit - PPDS', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'centralContacts': [{'name': 'Moderna WeCare Team', 'role': 'CONTACT', 'email': 'WeCareClinicalTrials@modernatx.com', 'phone': '1-866-663-3762'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ModernaTX, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}