Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-10 @ 6:51 AM
Study NCT ID:
NCT06553768
Status:
RECRUITING
Last Update Posted:
2025-12-11
First Post:
2024-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015209', 'term': 'Cholangitis, Sclerosing'}, {'id': 'D011537', 'term': 'Pruritus'}, {'id': 'D001656', 'term': 'Biliary Atresia'}], 'ancestors': [{'id': 'D002761', 'term': 'Cholangitis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722912', 'term': 'maralixibat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2024-08-08', 'studyFirstSubmitQcDate': '2024-08-13', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in the ItchRO(Obs) severity score', 'timeFrame': 'From baseline to average of week 13 to week 20', 'description': 'ItchRO(Obs) severity score = Itch Reported Outcome Observer assessment severity score; scale between 0 (not itchy at all) and 4 (extremely itchy); the lower the score the better.'}], 'secondaryOutcomes': [{'measure': 'Mean change in total sBA (serum bile acid) level', 'timeFrame': 'From baseline to average of week 12 and week 20'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pruritus', 'Cholestatic Liver Disease', 'Biliary Atresia'], 'conditions': ['Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://mirumpharma.com/', 'label': 'Mirum Pharmaceuticals homepage'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric and adult participants who have cholestatic liver disease with pruritus that has been refractory to other therapies, and who have no other treatment options.', 'detailedDescription': 'This study will be conducted in multiple sites in North America, Europe, Middle East and South America.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Informed consent and assent (as applicable)\n2. Age ≥6 months at time of baseline visit\n3. Diagnosis of cholestatic liver disease with cholestatic pruritus based on the presence of chronic liver biochemical abnormalities (\\>90 days) and/or pathological evidence of progressive liver disease.\n4. If taking antipruritics or ursodeoxycholic acid, the participant has to be on a stable dosing regimen (i.e., same dose and frequency in the 30 days prior to the screening visit and will continue this dosing regimen up to Week 40 \\[adjustment for body weight is allowed\\]).\n5. Access to email or telephone for scheduled participant contacts and access to smart phone or tablet for PROs.\n6. Ability to read and/or understand the questionnaires (both caregivers and participants ≥9 years of age).\n7. For participants ≤18 years of age: Access to consistent caregiver(s) during the study.\n\nExclusion Criteria:\n\nThose who meet any of the following criteria are NOT eligible to participate in the study:\n\n1. Diagnosis of ALGS, ICP, PBC, PFIC, or PSC with native liver.\n2. Active atopic dermatitis or other non- cholestatic diseases associated with pruritus that are not controlled by standard treatment and that may interfere with the severity assessment of cholestasis-associated pruritus.\n3. Decompensated cirrhosis or complications of cirrhosis (e.g., esophageal or gastric variceal bleeding in the last 6 months, high-risk esophageal or gastric varices, ascites, hepatic encephalopathy, hepatorenal syndrome). Patients with compensated cirrhosis with preserved hepatic synthetic function and absence of complications are eligible.\n4. Suspected or proven cholangiocarcinoma or hepatocellular carcinoma.\n5. Unstable and/or serious medical disease that is likely to impair the ability to participate in all aspects of the study, confound efficacy and/or safety assessments, or result in substantially shortened life expectancy (e.g., any active malignancy including hematological malignancy, end-stage heart failure, active infection, acute and chronic diarrhea). Exceptionally, previous history of malignancy, adequately treated/in remission, that in opinion of investigator and medical monitor does not impact participant safety and participation in the study, may be allowed.\n6. Laboratory results during the screening visit as follows:\n\n 1. Platelet count ≤70,000/mm3. Patients with any condition that further increases bleeding risk are excluded.\n 2. Albumin \\<30 g/L\n 3. INR ≥1.5 (after intravenous or subcutaneous supplementation of vitamin K)\n 4. Total bilirubin \\>10 mg/dL\n 5. ALT \\>10× ULN\n7. Use of an IBAT inhibitor within 8 weeks prior to the screening visit.\n8. Known intolerance/hypersensitivity to maralixibat or its excipients.\n9. History of nonadherence to medical regimens, unreliability, medical condition, mental instability, or cognitive impairment that, in the opinion of the investigator, could compromise the validity of informed consent, compromise the safety of the participant, or lead to nonadherence with the study protocol or inability to conduct the study procedures.'}, 'identificationModule': {'nctId': 'NCT06553768', 'briefTitle': 'Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mirum Pharmaceuticals, Inc.'}, 'officialTitle': 'Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Participants With Cholestatic Pruritus', 'orgStudyIdInfo': {'id': 'MRX-802'}, 'secondaryIdInfos': [{'id': '2024-511287-85-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Maralixibat', 'description': 'Participants will receive maralixibat oral solution 300 μg/kg orally once daily for 1 week and then twice daily for 39 weeks.', 'interventionNames': ['Drug: Maralixibat']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo matched to maralixibat oral solution orally once daily for 1 week and then twice daily for 19 weeks. After 20 weeks, participants will receive maralixibat oral solution 300 μg/kg orally once daily for 1 week and then twice daily for 19 weeks.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Maralixibat', 'type': 'DRUG', 'otherNames': ['Formerly LUM001, SHP625'], 'description': 'Maralixibat will be provided as an oral solution along with 0.5-, 1.0-, and 3.0-mL sized dosing dispensers. During the double-blind dose escalation period (4 weeks), the study drug (maralixibat) will be administered once daily for 1 week and then twice daily (BID; morning and evening). During the double-blind stable dosing period (16 weeks), participants will be treated with 300 μg/kg BID or the maximum tolerated dose (determined during the double-blind dose-escalation period) of maralixibat. During the open-label dose escalation period (4 weeks), all participants will receive maralixibat treatment once daily for 1 week and then twice daily (BID; morning and evening). During the open-label stable dosing period (at least 16 weeks), participants will be treated with 300 μg/kg BID or the maximum tolerated dose (determined during the open-label dose-escalation period) of maralixibat.', 'armGroupLabels': ['Maralixibat']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo matched to maralixibat will be provided as an oral solution along with 0.5-, 1.0-, and 3.0-mL sized dosing dispensers. During the double-blind dose escalation period (4 weeks), study drug will be administered once daily for 1 week and then twice daily (BID; morning and evening). During the double-blind stable dosing period (16 weeks), participants will be treated with 300 μg/kg BID or the maximum tolerated dose (determined during the double-blind dose-escalation period) of study drug. During the open-label dose escalation period (4 weeks), all participants will receive maralixibat treatment once daily for 1 week and then twice daily (BID; morning and evening). During the open-label stable dosing period (16 weeks), participants will be treated with 300 μg/kg BID or the maximum tolerated dose (determined during the open-label dose-escalation period) of maralixibat.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Siri Boonsawat', 'role': 'CONTACT', 'email': 'sboonsawat@chla.usc.edu', 'phone': '323-361-4566'}, {'name': 'Chuan-Hao Lin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital Los Angeles (CHLA)", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yael Bichman', 'role': 'CONTACT', 'email': 'bichman@stanford.edu'}, {'name': 'Noelle Ebel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Stanford Children's Health in Palo Alto", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lee Bass, MD', 'role': 'CONTACT'}, {'name': 'Lee Bass, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Lurie Children's Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shawan Stewart', 'role': 'CONTACT', 'email': 'shawan.stewart@ochsner.org', 'phone': '504-894-2873'}, {'name': 'Ryan Himes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ochsner Clinic Foundation', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rozanne Groen', 'role': 'CONTACT', 'email': 'rozanne.groen@nyulangone.org', 'phone': '646-754-2206'}, {'name': 'Jennifer Vittorio, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jamie Chu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rachel Nuccitelli', 'role': 'CONTACT', 'email': 'tcrcstudyreferral@cumc.columbia.edu', 'phone': '212-305-3839'}, {'name': 'Mercedes Martinez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Morgan Stanley Children's Hospital - NewYork Presbyterian", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27520', 'city': 'Morrisville', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Research Coordinator', 'role': 'CONTACT', 'email': 'EXPANDstudy@science37.com', 'phone': '984-355-0418'}], 'facility': 'Science 37, Inc (Remote-homebase Telemedicine)', 'geoPoint': {'lat': 35.82348, 'lon': -78.82556}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexander Miethke, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Iraklis Petrof', 'role': 'CONTACT', 'email': 'petrofi@chop.edu', 'phone': '267-426-0970'}, {'name': 'Kathy Loomes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Saeed Mohammad, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '832-822-1343'}, {'name': 'Anna Banc-Husu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ann Rutherford', 'role': 'CONTACT', 'email': 'ann.rutherford@hsc.utah.edu', 'phone': '801-585-9495'}, {'name': 'Kyle Jensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Contact GI Research', 'role': 'CONTACT', 'email': 'GIResearch@seattlechildrens.org', 'phone': '206-987-2721'}, {'name': 'Melissa Young', 'role': 'CONTACT', 'email': 'Melissa.young@seattlechildrens.org', 'phone': '206-987-1037'}, {'name': 'Pamela Valentino, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Brasília', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Elisa de Carvalho, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de Criança de Brasília (HCB)', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}, {'city': 'Porto Alegre', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Cristina Targa Ferreira, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital da Criança Santo Antonio', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'André Henrique Silva Lima', 'role': 'CONTACT', 'email': 'andre.hlima@hsl.org.br', 'phone': '+55 3391-5011'}, {'name': 'Gilda Porta, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Sírio-Libanês', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Susan Gilmour, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Stollery Children's Hospital", 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mohammad Louay Alakhrass', 'role': 'CONTACT', 'email': 'Mohammad.alakhrass@chu-lyon.fr', 'phone': '+33 4 72 68 13 43'}, {'name': 'Matthias Ruiz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Femme Mère Enfant', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13005', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bertrand Roquelaure, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpitaux Universitaires de Marseille Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hubert Lesur', 'role': 'CONTACT', 'email': 'hubert.lesur-ext@aphp.fr', 'phone': '+33 145212968'}, {'name': 'Emmanuel Gonzales, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Kremlin Bicêtre', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Hamburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sebastian Schulz-Jürgensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Hamburg Eppendorf - Klinik für Kinder- und Jugendmedizin', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Munich', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Eberhart Lurz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'LMU Klinikum - Kinderklinik und Kinderpoliklinik im Dr. von Haunerschen Kinderspital', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '24127', 'city': 'Bergamo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Ester Benigno', 'role': 'CONTACT', 'email': 'ebenigno@asst-pg23.it', 'phone': '+39 352674311'}, {'name': "Lorenzo D'Antiga, MD", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera Papa Giovanni XXIII', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '90127', 'city': 'Palermo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanna Lo Iacono', 'role': 'CONTACT', 'email': 'gloiacono@ismett.edu', 'phone': '+39 3346310393'}, {'name': 'Giusy Ranucci, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ISMETT - Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '00165', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Simona Donato', 'role': 'CONTACT', 'email': 'simona.donato@opbg.net', 'phone': '+39 668597284'}, {'name': 'Andrea Pietrobattista', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Pediatrico Bambino Gesu', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Beirut', 'status': 'RECRUITING', 'country': 'Lebanon', 'contacts': [{'name': 'Adib Moukarzel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hotel Dieu de France', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'city': 'Mexico City', 'status': 'NOT_YET_RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Adriana Gómez Martínez, MD', 'role': 'CONTACT', 'email': 'adriana.gomezmtz@yahoo.com.mx', 'phone': '+52 5555783785'}, {'name': 'Alejandra Sánchez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Infantil de México Federico Gómez', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Zapopan', 'status': 'NOT_YET_RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Krisztina Lévai', 'role': 'CONTACT', 'email': 'krisztale@yahoo.co.uk', 'phone': '+52 33 14711074'}, {'name': 'Joshue Covarrubias, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Consultario de Joshue David Covarrubias Esquer', 'geoPoint': {'lat': 20.72111, 'lon': -103.38742}}, {'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Magdalena Kozlowska', 'role': 'CONTACT', 'email': 'm.kozlowska@ipczd.pl', 'phone': '+48.503.103.529'}, {'name': 'Piotr Czubkowski, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Instytut Pomnik Centrum Zdrowia Dziecka', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '12713', 'city': 'Riyadh', 'status': 'NOT_YET_RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'Mohammad Shagrani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'King Faisal Specialist Hospital & Research Center', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Cristina Molera, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Sant Joan de Deu', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jesus Quintero, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Hospital Universitario Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Esteban Frauca, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Katie Tupper', 'role': 'CONTACT', 'email': 'katietupper@nhs.net', 'phone': '+44 203-299-9841'}, {'name': 'Richard Thompson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "King's College Hospital NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Clinical Trials Mirum', 'role': 'CONTACT', 'email': 'clinicaltrials@mirumpharma.com', 'phone': '+16506674085'}, {'name': 'Medinfo Mirum', 'role': 'CONTACT', 'email': 'medinfo@mirumpharma.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mirum Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}