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NCT04280718Active, not recruitingPhase 2

A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)

Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Source: ClinicalTrials.gov · Last updated 29 Jun 2025

Brief summary (registry, in English)

This is the open-label extension study of phase II ARGX-113-1802 to evaluate the long-term safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP. Patients already stabilized on efgartigimod PH20 SC will also have the opportunity to participate in a sub study to explore less frequent dosing of efgartigimod PH20 SC.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
229 (actual)
First submitted
20 Feb 2020
Start date
18 Sept 2020
Primary completion date
30 Apr 2027
Lead sponsor
argenx
NCT number
NCT04280718
EU CT number
2023-507885-21-00
EudraCT number
2019-003107-35

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 229
  • From 18 Sept 2020 to the primary completion date, 30 Apr 2027
  • 135 sites in 24 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.

Prior treatment

  • Week-48/ED visit in the ARGX-113-1802 trial or the Week-48 visit of the previous OLE participation occurred more than 14 days prior to SD1 of the OLE trial or the start of a new treatment cycle in the OLE trial and more than 21 days since the last dose of IMP.

Other illness

  • Patients with clinical evidence of other significant serious disease or patients who underwent a recent or have a planned major surgery, or patients who (intend to) use prohibited medications (see protocol) and therapies during the trial, or any other reason which could confound the results of the trial or put the patient at undue risk.

Other

  • Pregnant and lactating women and those intending to become pregnant during the trial.

Who the study is looking for

  • Ability to understand the requirements of the trial, provide written informed consent (including consent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including required trial visits) of this trial.
  • Male or female patient with one of the following options:
    • Have completed the Week-48 visit of Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgartigimod PH20 SC; or
    • Have deteriorated during Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgartigimod PH20 SC, or
    • Have been offered the participation in the OLE trial due to early termination of the ARGX-113-1802 trial (because sufficient events for the primary endpoint analysis of the that trial have been reached and it is stopped) and are considered to be eligible for treatment with efgartigimod PH20 SC treatment; or
    • Have completed the Week-48 visit of the previous cycle of the OLE trial and are considered to be eligible to continue with efgartigimod PH20 SC treatment.
  • Women of childbearing potential who have a negative urine pregnancy test at baseline before IMP administration.
  • Women of childbearing potential must use an acceptable method of contraception from signing the ICF until the date of the last administration of IMP.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (135)

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

SiteCityCountrySite status
Johannes Kepler University
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LinzAustriaRecruiting
Medical University of Vienna
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ViennaAustriaRecruiting
Antwerp University Hospital
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EdegemBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Centre Hospitalier Regional de la Citadelle
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LiègeBelgiumRecruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumRecruiting
Military Medical Academy
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PlevenBulgariaRecruiting
Alexandrovska University Hospital
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SofiaBulgariaRecruiting
Diagnostics And Consultation Center Convex Ltd.
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SofiyaBulgariaRecruiting
Investigator site 0860033
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BeijingChinaUnknown status
Investigator site 860041
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ChangshaChinaUnknown status
Investigator site 0860036
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ChengduChinaUnknown status
Investigator site 860049
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ChifengChinaUnknown status
Investigator site 0860038
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FuzhouChinaUnknown status
Investigator site 0860050
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GuangzhouChinaUnknown status
Investigator site 0860032
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GuanzhouChinaUnknown status
Investigator site 0860045
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GuiyangChinaUnknown status
Investigator site 0860035
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HangzhouChinaUnknown status
Investigator site 0860031
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JinanChinaUnknown status
Investigator site 0860040
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NanchangChinaUnknown status
Investigator site 0860043
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NanjingChinaUnknown status
Investigator site 860047
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ShanghaiChinaUnknown status
Investigator site 0860028
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ShanghaiChinaUnknown status
Investigator site 0860042
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TianjinChinaUnknown status
Investigator site 0860034
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WuhanChinaUnknown status
Investigator site 0860029
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WuhanChinaUnknown status
Investigator site 0860048
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Xi'anChinaUnknown status
Investigator site 0860054
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XianyangChinaUnknown status
Investigator site 4200010
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Hradec KrálovéCzechiaUnknown status
University Hospital Cologne AöR
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CologneGermanyCompleted
Universitaetsklinikum Schleswig-Holstein
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KielGermanyCompleted
St. Josef-Hospital
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PotsdamGermanyCompleted
Aarhus Universitetshospital
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Aarhus NDenmarkRecruiting
Rigshospitalet
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Copenhagen OeDenmarkRecruiting
Odense University Hospital
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Odense CDenmarkRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital Clínico San Carlos
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MadridSpainRecruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceRecruiting
Chu Gabriel Montpied
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Clermont-FerrandFranceRecruiting
Centre Hospitalier Et Universitaire De Limoges
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Limoges Cedex 1FranceRecruiting
Hospital Hotel Dieu
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NantesFranceRecruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceRecruiting
Investigator site 440026
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LondonUnited KingdomUnknown status
Investigator site 0440016
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OxfordUnited KingdomUnknown status
Investigator site 0440018
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SheffieldUnited KingdomUnknown status
Investigator site 9950020
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KutaisiGeorgiaUnknown status
Investigator site 9950005
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TbilisiGeorgiaUnknown status
Investigator site 9950004
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TbilisiGeorgiaUnknown status
Investigator Site 9950003
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TbilisiGeorgiaUnknown status
Investigator site 9950002
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TbilisiGeorgiaUnknown status
Investigator site 9720004
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Tel AvivIsraelUnknown status
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyRecruiting
Careggi University Hospital
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FlorenceItalyRecruiting
Azienda Ospedaliera Universitaria Gaetano Martino Messina
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MessinaItalyRecruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyRecruiting
IRCCS Foundation Istituto Neurologico Carlo Besta
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MilanItalyRecruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyRecruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyRecruiting
Investigator site 0810035
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Bunkyō CityJapanUnknown status
Investigator site 0810002
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ChibaJapanUnknown status
Investigator site 0810030
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FuchūJapanUnknown status
Investigator site 0810031
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FukuokaJapanUnknown status
Investigator site 0810065
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GinowanJapanUnknown status
Investigator site 0810066
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HakodateJapanUnknown status
Investigator site 0810058
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HiroshimaJapanUnknown status
Investigator site 0810029
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KawagoeJapanUnknown status
Investigator site 0810026
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KodairaJapanUnknown status
Investigator site 810061
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KyotoJapanUnknown status
Investigator site 0810027
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MibuJapanUnknown status
Investigator site 0810032
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NagoyaJapanUnknown status
Investigator site 0810003
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OsakaJapanUnknown status
Investigator site 0810007
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OsakaJapanUnknown status
Investigator site 0810063
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SuitaJapanUnknown status
Investigator site 0810036
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tabashi CityJapanUnknown status
Investigator site 0810064
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TokushimaJapanUnknown status
Investigator site 0810060
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YokohamaJapanUnknown status
Investigator site 31
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RigaLatviaUnknown status
Amsterdam UMC
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AmsterdamNetherlandsRecruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsRecruiting
Michalski I Partnerzy Lekarze sp.p.
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CracowPolandRecruiting
Centrum Neurologii Krzysztof Selmaj
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ŁódźPolandRecruiting
Clinirem Sp. z o.o.
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LublinPolandRecruiting
Teo Health S.A.
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BrasovRomaniaRecruiting
Neurocity S.R.L.
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BucharestRomaniaRecruiting
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
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TimisoaraRomaniaRecruiting
Investigator site 3810001
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BelgradeSerbiaUnknown status
Investigator site 3810003
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BelgradeSerbiaUnknown status
Investigator site 3810004
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KragujevacSerbiaUnknown status
Investigator site 070017
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Kazan'RussiaUnknown status
Investigator site 0070023
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Kazan'RussiaUnknown status
Investigator site 0070020
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MoscowRussiaUnknown status
Investigator site 70021
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MoscowRussiaUnknown status
Investigator site 0070019
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Rostov-on-DonRussiaUnknown status
Investigator site 0070014
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Saint PetersburgRussiaUnknown status
Investigator site 0070021
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SaranskRussiaUnknown status
Investigator site 8860013
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TainanTaiwanUnknown status
Investigator site 8860016
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TaipeiTaiwanUnknown status
Investigator site 8860012
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TaipeiTaiwanUnknown status
Investigator site 8860017
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TaoyuanTaiwanUnknown status
Investigator Site 3800012
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DniproUkraineUnknown status
Investigator Site 3800010
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Ivano-FrankivskUkraineUnknown status
Investigator site 3100013
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KyivUkraineUnknown status
Investigator site 3800008
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LutskUkraineUnknown status
Investigator site 3800011
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ZaporizhzhyaUkraineUnknown status
Investigator Site 0010066
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AustinUnited StatesUnknown status
Investigator site 0010065
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BirminghamUnited StatesUnknown status
Investigator site 0010072
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Boca RatonUnited StatesUnknown status
Investigator site 0010032
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CarlsbadUnited StatesUnknown status
Investigator site 0010057
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CentennialUnited StatesUnknown status
Investigator site 0010003
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Chapel HillUnited StatesUnknown status
Investigator site 0010064
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ColumbusUnited StatesUnknown status
Investigator site 0010144
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Coral SpringsUnited StatesUnknown status
Investigator site 0010015
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FairwayUnited StatesUnknown status
Investigator site 0010011
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Iowa CityUnited StatesUnknown status
Investigator site 0010023
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JacksonvilleUnited StatesUnknown status
Investigator site 10147
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LexingtonUnited StatesUnknown status
Investigator site 0010068
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MaitlandUnited StatesUnknown status
Investigator site 0010059
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MiamiUnited StatesUnknown status
Investigator site 10168
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New YorkUnited StatesUnknown status
Investigator site 0010047
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PhiladelphiaUnited StatesUnknown status
Investigator site 0010007
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PhiladelphiaUnited StatesUnknown status
Investigator site 0010013
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PhoenixUnited StatesUnknown status
Investigator site 10190
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PomonaUnited StatesUnknown status
Investigator site 0010160
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Rancho MirageUnited StatesUnknown status
Investigator site 0010061
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RichmondUnited StatesUnknown status
Investigator site 0010009
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San AntonioUnited StatesUnknown status
Investigator site 0010071
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San FranciscoUnited StatesUnknown status
Investigator site 0010055
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ScottsdaleUnited StatesUnknown status
Investigator site 0010006
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TampaUnited StatesUnknown status
Investigator site 900025
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BursaTurkey (Türkiye)Unknown status
Investigator site 900021
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IzmirTurkey (Türkiye)Unknown status
Investigator site 900022
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SamsunTurkey (Türkiye)Unknown status

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