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NCT07222332RecruitingPhase 3

A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Preserve Beta Cell Function in Participants Newly Diagnosed With Type 1 Diabetes Aged ≥1 to <36 Years

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to find out if baricitinib can preserve beta-cell function in participants newly diagnosed with type 1 diabetes. Participation in the study will last about 60 weeks.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
300 (estimated)
First submitted
27 Oct 2025
Start date
5 Feb 2026
Primary completion date
Jul 2028
Lead sponsor
Eli Lilly and Company
NCT number
NCT07222332
EU CT number
2025-522170-36-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 300
  • From 5 Feb 2026 to the primary completion date, Jul 2028
  • 134 sites in 20 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Have any other type of diabetes including gestational
  • Have had a heart attack, heart disease, stroke, or heart failure
  • Have a history or high risk of venous thromboembolism, lymphoproliferative disease or malignancy
  • Have a current or recent clinically serious medical condition or infection

Other

  • Have uncontrolled high blood pressure

Who the study is looking for

  • Have a new diagnosis of type 1 diabetes within 100 days prior to starting study intervention
  • Have at least one diabetes-related autoantibody found at screening
  • Show signs of remaining beta-cell function
    • stimulated (peak or 90 min) C-peptide ≥0.2 nmol/L (0.6 ng/mL) at screening
  • Weigh at least 8 kilograms (kg) (18 pounds) at screening

Age in the registry: 1 year to 35 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (134)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Women's and Children's Hospital
Coordinator of this site? Confirm its status
AdelaideAustraliaRecruiting
Austin Health - Repatriation Hospital
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Heidelberg WestAustraliaRecruiting
Ipswich Hospital
Coordinator of this site? Confirm its status
IpswichAustraliaRecruiting
Royal Children's Hospital
Coordinator of this site? Confirm its status
MelbourneAustraliaNot yet recruiting
Southern Adelaide Diabetes & Endocrine Services
Coordinator of this site? Confirm its status
Oaklands ParkAustraliaRecruiting
The Royal Melbourne Hospital
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ParkvilleAustraliaRecruiting
Perth Children's Hospital
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PerthAustraliaRecruiting
Sydney Children's Hospital
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RandwickAustraliaRecruiting
The Children's Hospital at Westmead
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WestmeadAustraliaRecruiting
Hopital Erasme
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AnderlechtBelgiumRecruiting
Universitair Ziekenhuis Antwerpen
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EdegemBelgiumRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
UZ Brussel
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JetteBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumRecruiting
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
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NamurBelgiumRecruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumRecruiting
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Coordinator of this site? Confirm its status
YvoirBelgiumRecruiting
Hospital Universitário Maria Aparecida Pedrossian
Coordinator of this site? Confirm its status
Campo GrandeBrazilRecruiting
Centro de Diabetes Curitiba
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CuritibaBrazilRecruiting
Quanta Diagnóstico e Terapia
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CuritibaBrazilRecruiting
Centro De Diabetes Metabolismo E Endocrinologia
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FortalezaBrazilRecruiting
Cendi - Endocrinologia e Diabetes
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GoiâniaBrazilRecruiting
Centro de Pesquisa Clínica de Marília - CPCLIM
Coordinator of this site? Confirm its status
MaríliaBrazilRecruiting
Instituto da Crianca com Diabetes
Coordinator of this site? Confirm its status
Porto AlegreBrazilRecruiting
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFM -T
Coordinator of this site? Confirm its status
Ribeirão PretoBrazilRecruiting
Universidade Federal Do Rio de Janeiro
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Rio de JaneiroBrazilRecruiting
CPCLIN
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São PauloBrazilRecruiting
Hospital das Clinicas FMUSP
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São PauloBrazilRecruiting
Instituto de Pesquisa Clinica
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São PauloBrazilRecruiting
Clínica Hepatogastro JK
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São PauloBrazilRecruiting
IBTED - Tecnologia e Educação em Diabetes
Coordinator of this site? Confirm its status
São PauloBrazilRecruiting
CEDOES
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VitóriaBrazilRecruiting
Alberta Children's Hospital
Coordinator of this site? Confirm its status
CalgaryCanadaRecruiting
CIUSSS- saguenay-Lac-Saint-Jean
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ChicoutimiCanadaRecruiting
Alberta Diabetes Institute
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EdmontonCanadaNot yet recruiting
St. Joseph's Health Care
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LondonCanadaRecruiting
Centricity Research Ottawa LMC Endocrinology
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OttawaCanadaRecruiting
CHUL et Centre mère-enfant Soleil
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QuébecCanadaRecruiting
BC Diabetes Office
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VancouverCanadaRecruiting
Nemocnice Jihlava prispevkova organizace
Coordinator of this site? Confirm its status
Jihlava 1CzechiaActive, not recruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaActive, not recruiting
MILAN KVAPIL s.r.o.
Coordinator of this site? Confirm its status
PragueCzechiaActive, not recruiting
Hannoversche Kinderheilanstalt
Coordinator of this site? Confirm its status
HanoverGermanyRecruiting
Schwerpunktpraxis für Diabetes Hormone & Stoffwechsel
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HofGermanyRecruiting
Klinikum Karlsburg
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KarlsburgGermanyRecruiting
Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz
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Ludwigshafen am RheinGermanyRecruiting
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
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MunichGermanyRecruiting
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
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Oldenburg in HolsteinGermanyRecruiting
Asklepios-Klinik, Sankt Augustin GmbH
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Sankt AugustinGermanyRecruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyRecruiting
Hospital Universitario de Cruces
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BarakaldoSpainActive, not recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital Sant Joan De Deu Barcelona
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Esplugues de LlobregatSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainActive, not recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
HUS-Yhtymae
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HelsinkiFinlandRecruiting
Oulu University Hospital
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OuluFinlandRecruiting
Tampere University Hospital
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TampereFinlandRecruiting
Varsinais-Suomen hyvinvointialue
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TurkuFinlandRecruiting
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
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Bouches-du-RhôneFranceRecruiting
Centre Hospitalier Sud Francilien
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Corbeil Essonnes CedexFranceRecruiting
Centre Hospitalier Universitaire de Grenoble
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IsèreFranceRecruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceRecruiting
Pitié-Salpêtrière University Hospital
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ParisFranceRecruiting
Hopital Necker Enfants Malades
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ParisFranceRecruiting
Robert Debre University Hospital
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ParisFranceRecruiting
Hospices Civils de Lyon – Hôpital Louis Pradel
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RhôneFranceRecruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceRecruiting
Aberdeen Royal Infirmary
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AberdeenUnited KingdomRecruiting
Birmingham Children's Hospital
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BirminghamUnited KingdomRecruiting
Queen Elizabeth Hospital Birmingham
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BirminghamUnited KingdomRecruiting
Southmead Hospital
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BristolUnited KingdomRecruiting
Addenbrooke's Hospital
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CambridgeUnited KingdomRecruiting
University Hospital of Wales
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CardiffUnited KingdomRecruiting
Churchill Hospital
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OxfordUnited KingdomRecruiting
Southampton General Hospital
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SouthamptonUnited KingdomRecruiting
Soroka Medical Center
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BeershebaIsraelRecruiting
Yitzhak Shamir Medical Center
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Beer YaacovIsraelRecruiting
Linn Medical Center
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HaifaIsraelActive, not recruiting
Rambam Health Care Campus
Coordinator of this site? Confirm its status
HaifaIsraelRecruiting
Institute of Diabetes, Technology and Research - Clalit Health
Coordinator of this site? Confirm its status
HerzliyaIsraelActive, not recruiting
Hadassah medical Center
Coordinator of this site? Confirm its status
JerusalemIsraelActive, not recruiting
Meir Medical Center
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Kfar SabaIsraelRecruiting
Schneider Children's Medical Center
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Petah TikvaIsraelRecruiting
Rabin Medical Center
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Petah TikvaIsraelActive, not recruiting
Sheba medical center
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Ramat GanIsraelActive, not recruiting
Sourasky Medical Center
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Tel AvivIsraelRecruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
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AnconaItalyActive, not recruiting
Azienda Ospedaliera Universitaria Meyer IRCCS
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FlorenceItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyActive, not recruiting
Università degli Studi di Messina
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MessinaItalyActive, not recruiting
Ospedale San Raffaele S.r.l.
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MilanItalyActive, not recruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyActive, not recruiting
Azienda Ospedaliero Universitaria Maggiore della Carità
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NovaraItalyActive, not recruiting
Azienda Ospedaliera di Padova
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PadovaItalyActive, not recruiting
Azienda Ospedaliera Universitaria Integrata Verona
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VeronaItalyActive, not recruiting
Iuhw Ichikawa General Hospital
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IchikawaJapanNot yet recruiting
Saitama Medical University Hospital
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IrumaJapanRecruiting
Shiga General Hospital
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MoriyamaJapanNot yet recruiting
Abeno Medical Clinic
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OsakaJapanRecruiting
Sendai City Hospital - Asutonagamachi
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SendaiJapanNot yet recruiting
Shizuoka Children's Hospital
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ShizuokaJapanNot yet recruiting
Diabeter Nederland B.V.
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RotterdamNetherlandsActive, not recruiting
Helse Fonna HF
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HaugesundNorwayRecruiting
Akershus University Hospital
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LoerenskogNorwayRecruiting
Oslo Universitetssykehus HF
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OsloNorwayRecruiting
Helse Stavanger HF
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StavangerNorwayRecruiting
St. Olavs hospital HF
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TrondheimNorwayRecruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandActive, not recruiting
Umed Clinical Trials Sp. z o.o.
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LodzPolandActive, not recruiting
MTZ Clinical Research powered by Pratia
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WarsawPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandActive, not recruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalRecruiting
Unidade Local De Saude De Santo Antonio E.P.E.
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PortoPortugalRecruiting
Unidade Local De Saude Do Alto Minho E.P.E.
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Viana do CasteloPortugalRecruiting
Unidade Local de Saúde de Gaia/Espinho, E. P. E
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Vila Nova de GaiaPortugalRecruiting
ProbarE i Lund AB
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LundSwedenActive, not recruiting
Region Oerebro Laen
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OrebroSwedenActive, not recruiting
Region Jaemtland Haerjedalen
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OstersundSwedenActive, not recruiting
ProbarE i Stockholm AB
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StockholmSwedenActive, not recruiting
NU Hospital Group-Vaestra Goetalandsregionen
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UddevallaSwedenActive, not recruiting
Institute of Endocrinology and Metabolism named after Komissarenko
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KievUkraineRecruiting
Kyiv City Endocrinological Center
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KyivUkraineRecruiting
Zakarpattia Endoclinic
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UzhhorodUkraineRecruiting
Vinnytsia Regional Clinical Endocrinology Dispensary
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VinnytsiaUkraineRecruiting
Barbara Davis Center for Childhood Diabetes
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AuroraUnited StatesRecruiting
University of Virginia
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CharlottesvilleUnited StatesRecruiting
Driscoll Children's Hospital
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Corpus ChristiUnited StatesRecruiting
Children's Hospital of Philadelphia (CHOP)
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PhiladelphiaUnited StatesNot yet recruiting
Tallahassee Memorial Healthcare
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TallahasseeUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.