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Studie van Erdafitinib intravesicaal toedieningssysteem voor gelokaliseerde blaaskanker

2 november 2026 bijgewerkt door: Janssen Research & Development, LLC

Fase 1-studie van Erdafitinib Intravesical Delivery System (TAR-210) bij deelnemers met niet-spierinvasieve of spierinvasieve blaaskanker en geselecteerde FGFR-mutaties of -fusies

The purpose of the study in Part 1 (dose escalation) and in Part 2 (dose expansion) is to determine the recommended Phase 2 dose(s) (RP2D[s]) and evaluate preliminary clinical efficacy. Part 3 (dose expansion) will confirm safety and preliminary clinical activity at the RP2D. Part 4 (RP2D expansion; MoonRISe-2) will assess the overall complete response (CR) in participants with intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC; means the cancer cells are only in the bladder's inner lining).

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Bladder cancer is one of the most common malignancy worldwide, and non-muscle invasive (NMIBC) requires intensive regimens of frequent monitoring and local resection (transurethral resection of bladder [TURBT]). This study enrolls participants with non-muscle invasive or muscle invasive bladder cancer with activating fibroblast growth factor receptor (FGFR) mutations or fusions. Erdafitinib is a pan-FGFR inhibitor with demonstrated clinical activity when administered orally in patients with solid tumors, including bladder cancer, with FGFR genetic alterations. The Erdafitinib intravesical delivery system is designed to provide release of Erdafitinib in the bladder to treat localized bladder cancer, while reducing systemic toxicities. The study consists of a screening phase, a treatment phase, and a follow-up phase. Total duration of the study is approximately up to 7 years 4 months.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

235

Fase

  • Fase 2
  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver Prostate Centre Diamond Health Care Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Nova Scotia Health Authority
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St Josephs Healthcare Hamilton
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
  • Duitsland
      • Dresden, Duitsland, 01307
        • Universitatsklinikum Carl Gustav Carus Dresden
      • Duisburg, Duitsland, 47169
        • Urologicum Duisburg
      • Frankfurt am Main, Duitsland, 60590
        • Universitatsklinikum Frankfurt
      • Herne, Duitsland, 44625
        • Marien hospital Herne
      • Mettmann, Duitsland, 40822
        • Urologie Neandertal Praxis Mettmann
      • Münster, Duitsland, 48149
        • Universitatsklinikum Munster
      • Ulm, Duitsland, 89081
        • Universitaetsklinikum Ulm
  • Israël
      • Haifa, Israël, 3109601
        • Rambam Medical Center
      • Haifa, Israël, 3436212
        • Carmel Medical Center
      • Petah Tikva, Israël, 4941492
        • Rabin Medical Center
      • Tel Aviv, Israël, 64239
        • Tel Aviv Sourasky Medical Center
  • Japan
      • Fukuoka, Japan, 810 8563
        • National Hospital Organization Kyushu Medical Center
      • Kofu, Japan, 400-8506
        • Yamanashi Prefectural Central Hospital
      • Osaka, Japan, 558-8558
        • Osaka General Medical Center
      • Toyama, Japan, 930 0194
        • Toyama University Hospital
  • Nederland
      • Nijmegen, Nederland, 6525 GA
        • Radboud Umcn
      • Utrecht, Nederland, 3584 CX
        • UMC Utrecht
  • Spanje
      • Barcelona, Spanje, 08025
        • Fund. Puigvert
      • Barcelona, Spanje, 08036
        • Hosp Clinic de Barcelona
      • Barcelona, Spanje, 08035
        • Hosp Univ Vall D Hebron
      • Córdoba, Spanje, 14004
        • Hosp Reina Sofia
      • Madrid, Spanje, 28041
        • Hosp. Univ. 12 de Octubre
      • Madrid, Spanje, 28046
        • Hosp. Univ. La Paz
      • Madrid, Spanje, 28040
        • Hosp Univ Fund Jimenez Diaz
      • Valencia, Spanje, 46009
        • Instituto Valenciano de Oncologia
  • Verenigde Staten
    • Alabama
      • Birmingham, Alabama, Verenigde Staten, 35294
        • University of Alabama at Birmingham - The Kirklin Clinic
    • California
      • Los Angeles, California, Verenigde Staten, 90033
        • University of Southern California
    • Colorado
      • Lone Tree, Colorado, Verenigde Staten, 80124
        • Urology Associates of Denver
    • Florida
      • Hialeah, Florida, Verenigde Staten, 33016
        • Urological Research Network
      • Largo, Florida, Verenigde Staten, 33771
        • Advanced Urology Institute
      • Orlando, Florida, Verenigde Staten, 32804
        • Advent Health Orlando
      • Oxford, Florida, Verenigde Staten, 34484
        • Advanced Urology Institute 1
      • Tampa, Florida, Verenigde Staten, 33612
        • H Lee Moffitt Cancer Center
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60611
        • Northwestern University
      • Chicago Ridge, Illinois, Verenigde Staten, 60415
        • Associated Urological Specialists
    • Indiana
      • Greenwood, Indiana, Verenigde Staten, 46143
        • Urology of Indiana
      • Merrillville, Indiana, Verenigde Staten, 46410
        • Urologic Specialists of Northwest Indiana
    • Kentucky
      • Lexington, Kentucky, Verenigde Staten, 40506
        • University of Kentucky
    • Louisiana
      • Lafayette, Louisiana, Verenigde Staten, 70508
        • Southern Urology LLC
    • Massachusetts
      • Plymouth, Massachusetts, Verenigde Staten, 02360
        • Greater Boston Urology
    • Missouri
      • St Louis, Missouri, Verenigde Staten, 63141
        • Specialty Clinical Research of St Louis
    • New Jersey
      • Hackensack, New Jersey, Verenigde Staten, 07601
        • Hackensack University Medical Center Urology
    • New York
      • Syracuse, New York, Verenigde Staten, 13210
        • Associated Medical Professionals
    • North Carolina
      • Charlotte, North Carolina, Verenigde Staten, 28204
        • Levine Cancer Institute, Carolinas HealthCare System
    • Ohio
      • Gahanna, Ohio, Verenigde Staten, 43230
        • Central Ohio Urology Group
    • South Carolina
      • Myrtle Beach, South Carolina, Verenigde Staten, 29572
        • Carolina Urologic Research Center
      • North Charleston, South Carolina, Verenigde Staten, 29406
        • Low Country Urology Clinics
    • Tennessee
      • Nashville, Tennessee, Verenigde Staten, 37209
        • Urology Associates
    • Texas
      • Austin, Texas, Verenigde Staten, 78745
        • Urology Austin
      • San Antonio, Texas, Verenigde Staten, 78229
        • Urology San Antonio Research
  • Zuid -Korea
      • Goyang-si, Zuid -Korea, 10408
        • National Cancer Center
      • Gwangju, Zuid -Korea, 61469
        • Chonnam National University Hospital
      • Seoul, Zuid -Korea, 03080
        • Seoul National University Hospital
      • Seoul, Zuid -Korea, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, Zuid -Korea, 06591
        • The Catholic University of Korea Seoul St Marys Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

Parts 1-3:

  • Muscle-invasive or recurrent, non-muscle-invasive urothelial carcinoma of the bladder
  • For selected Cohorts: Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing, approved by the sponsor prior to the start of study treatment. Local tissue-based results (if already existing) from next-generation sequencing (NGS) or polymerase chain reaction (PCR) tests performed in Clinical Laboratory Improvement Amendments (CLIA) -certified or equivalent laboratories, or results from commercially available PCR or NGS tests
  • Cohorts 1 and 2: Bacillus Calmette-Guérin (BCG) experienced, or participants with no BCG experience because BCG was not available as a treatment option in the participant's location within the previous 2 years and is currently unavailable. Participants who received an abbreviated course of BCG due to toxicity are still eligible
  • Cohort 1 only: Refuses or is not eligible for radical cystectomy (RC)
  • Cohorts 2 and 4: Willing and eligible for RC

Part 4:

  • Have histologically confirmed diagnosis of recurrent Intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC) Ta LG tumors
  • Must not have undergone tumor debulking or selective ablation of visible lesions; partial tumor biopsy to confirm diagnosis and provide tissue for biomarker testing is permitted as long as remaining tumor is at least 5 millimeter (mm) in size
  • Must submit tissue and urine for FGFR testing
  • Can have a prior or concurrent second malignancy which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment

Exclusion Criteria:

Parts 1-3:

  • Concurrent extra-vesical (that is, urethra, ureter, renal pelvis) transitional cell carcinoma of the urothelium
  • Prior treatment with an pan-fibroblast growth factor receptor (FGFR) inhibitor
  • Received pelvic radiotherapy <=6 months prior to the planned start of study treatment. If received pelvic radiotherapy greater than (>)6 months prior to the start of study treatment, there must be no cystoscopic evidence of radiation cystitis
  • Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe use of Erdafitinib intravesical delivery system
  • Indwelling urinary catheter. Intermittent catheterization is acceptable

Part 4:

  • Histologically confirmed diagnosis of T1 NMIBC, HR NMIBC (HG/G2 or HG/G3 or CIS) or MIBC, locally advanced, non-resectable, or metastatic urothelial carcinoma at any time prior to enrollment. Previous high grade (HG) disease is accepted as long as diagnosis date is greater than or equal to (>=5) years ago and there is documentation of low grade (LG) Ta thereafter
  • Known allergies, hypersensitivity, or intolerance to any study component or its excipients
  • Has a current diagnosis of newly diagnosed IR-NMIBC
  • Received an investigational treatment for bladder cancer after Transurethral Resection of the Bladder Tumor (TURBT) for the current NMIBC diagnosis or within 4 weeks or the agent/therapy washout period, whichever is longer, before the planned first dose of study treatment, or is currently enrolled in an investigational study
  • Evidence of current bladder perforation by cystoscopy or imaging

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Part 1: Dose Escalation

Participants with recurrent, bacillus Calmette-Guerin (BCG)-experienced high risk papillary-only Non-Muscle-Invasive Bladder Cancer (NMIBC), refusing or ineligible for radical cystectomy or with recurrent, intermediate-risk NMIBC will receive Erdafitinib Intravesical Delivery System. The dose will be escalated to determine preliminary recommended phase 2 dose(s) (RP2D[s]) for Part 2.
Geneesmiddel: Erdafitinib Intravesical Delivery System

Erdafitinib intravesical delivery system will be administered.

Andere namen:
  • JNJ-42756493
Experimenteel: Part 2: Dose Expansion

Participants in each of 5 disease-specific NMIBC or MIBC cohorts may be enrolled at one or more dose levels that have been determined to be safe in Part 1.
Geneesmiddel: Erdafitinib Intravesical Delivery System

Erdafitinib intravesical delivery system will be administered.

Andere namen:
  • JNJ-42756493
Experimenteel: Part 3: RP2D Dose Expansion

Participants in 2 of the disease-specific NMIBC cohorts (cohorts 1 and 3) may be enrolled at RP2D to determine the safety, evaluate PK and preliminary clinical activity.
Geneesmiddel: Erdafitinib Intravesical Delivery System

Erdafitinib intravesical delivery system will be administered.

Andere namen:
  • JNJ-42756493
Experimenteel: Part 4: Phase 2 Expansion

Participants with recurrent IR-NMIBC will be enrolled in this part to further evaluate the safety, efficacy, and PK of the selected RP2D.
Geneesmiddel: Erdafitinib Intravesical Delivery System

Erdafitinib intravesical delivery system will be administered.

Andere namen:
  • JNJ-42756493

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Parts 1 to 3: Number of Participants with Adverse Events (AEs)
Tijdsspanne: Up to approximately 7 years 4 months

An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Up to approximately 7 years 4 months
Parts 1 to 3: Number of Participants with AEs by Severity
Tijdsspanne: Up to approximately 7 years 4 months

Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Up to approximately 7 years 4 months
Part 1: Number of Participants with Dose-limiting Toxicity (DLT)
Tijdsspanne: Up to 28 days

Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Up to 28 days
Part 4: Overall Complete Response (CR) in Participants with Intermediate Risk-Non-Muscle Invasive Bladder Cancer (IR-NMIBC)
Tijdsspanne: Up to approximately 7 years 4 months

Overall CR is defined as the negative cystoscopy or positive cystoscopy with centrally reviewed biopsy negative for malignancy.
Up to approximately 7 years 4 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Parts 1 to 3: Plasma Concentration of Erdafitinib
Tijdsspanne: Cohorts 1, 3 and 5: up to 6 months; Cohort 2 and 4: up to 8 weeks

Plasma concentration of Erdafitinib will be reported.
Cohorts 1, 3 and 5: up to 6 months; Cohort 2 and 4: up to 8 weeks
Parts 1 to 3: Urine Concentration of Erdafitinib
Tijdsspanne: Cohorts 1, 3 and 5: up to 6 months; Cohort 2 and 4: up to 8 weeks

Urine concentration of Erdafitinib will be reported.
Cohorts 1, 3 and 5: up to 6 months; Cohort 2 and 4: up to 8 weeks
Parts 1 to 3: Cohorts 1 and 2: Recurrence-Free Survival (RFS)
Tijdsspanne: Up to approximately 7 years 4 months

RFS is defined as the time from start of treatment to the first detection of any new high-grade bladder cancer or upper tract urothelial carcinoma or positive urine cytology.
Up to approximately 7 years 4 months
Parts 1 to 3: Cohort 3 and 5: Complete Response (CR) Rate
Tijdsspanne: At 3 months

CR is defined as the absence of urothelial carcinoma by cystoscopy, confirmed pathologically at first assessment, and negative urine cytology.
At 3 months
Parts 1 to 3: Cohort 3 and 5: Duration of CR
Tijdsspanne: Up to approximately 7 years 4 months

Duration of CR is defined as the time from first documentation of CR until the date of documented recurrence or progression, or death, whichever comes first.
Up to approximately 7 years 4 months
Parts 1 to 3: Cohort 4: Pathological Complete Response (pCR) Rate
Tijdsspanne: Up to 8 weeks

pCR rate is defined as percentage of participants with no pathologic evidence of intravesical disease (pT0) and no pathologic evidence of nodal involvement (pN0).
Up to 8 weeks
Parts 1 to 3: Cohort 4: No Pathologic Evidence of Intravesical Disease (pT0)
Tijdsspanne: Up to 8 weeks

pT0 rate is defined as percentage of participants with no Pathologic Evidence of Intravesical Disease.
Up to 8 weeks
Parts 1 to 3: Cohort 4: Rate of downstaging to Less than (<) pT2
Tijdsspanne: Up to 8 weeks

Rate of downstaging to <pT2 is defined as percentage of participants with pT stage <2.
Up to 8 weeks
Part 4: Duration of CR (DoCR) in Participants with IR-NMIBC
Tijdsspanne: Up to approximately 7 years 4 months

Duration of CR is defined as the time from first documentation of CR until the date of documented recurrence or progression, or death, whichever comes first.
Up to approximately 7 years 4 months
Part 4: Complete Response (CR) at 3 Months in Participants with IR-NMIBC
Tijdsspanne: At Month 3

CR is defined as the negative cystoscopy or positive cystoscopy with centrally reviewed biopsy negative for malignancy at the first disease evaluation.
At Month 3
Part 4: Transurethral Resection of the Bladder Tumor (TURBT)-Free Survival in Participants With IR-NMIBC
Tijdsspanne: Up to approximately 7 years 4 months

Participants with TURBT-free survival will be reported.
Up to approximately 7 years 4 months
Part 4: Number of Participants with Treatment-Emergent Adverse Event (TEAEs) by Severity
Tijdsspanne: Up to approximately 7 years 4 months

TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline. Severity was assessed using National cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0. Severity grades ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Up to approximately 7 years 4 months
Part 4: Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score
Tijdsspanne: At baseline (Week 0), Weeks 12, 24, 36, 48, and at completion or discontinuation of study treatment (up to approximately 7 years 4 months)

The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the health-related quality of life (HRQoL) of participants with cancer. EORTC QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status / quality of life scale, and 6 single items. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptoms.
At baseline (Week 0), Weeks 12, 24, 36, 48, and at completion or discontinuation of study treatment (up to approximately 7 years 4 months)
Part 4: Change from Baseline in European Organization for the Research and Treatment of Cancer Non-Muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC 24) Score
Tijdsspanne: At baseline (Week 0), Weeks 12, 24, 36, 48, and at completion or discontinuation of study treatment (up to approximately 7 years 4 months)

EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with non-muscle-invasive bladder cancer. The questionnaire is designed to supplement the QLQ C30 and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity.
At baseline (Week 0), Weeks 12, 24, 36, 48, and at completion or discontinuation of study treatment (up to approximately 7 years 4 months)
Part 4: Percentage of Participants With Clinically Meaningful Change From Baseline in EORTC-QLQ-C30 Scores
Tijdsspanne: At baseline (Week 0), Weeks 12, 24, 36, 48, and at completion or discontinuation of study treatment (up to approximately 7 years 4 months)

The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. EORTC QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status/quality of life scale, and 6 single items. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptoms.
At baseline (Week 0), Weeks 12, 24, 36, 48, and at completion or discontinuation of study treatment (up to approximately 7 years 4 months)
Part 4: Percentage of Participants With Clinically Meaningful Change From Baseline in EORTC-QLQ-NMIBC24 Scores
Tijdsspanne: At baseline (Week 0), Weeks 12, 24, 36, 48, and at completion or discontinuation of study treatment (up to approximately 7 years 4 months)

EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with non-muscle-invasive bladder cancer. The questionnaire is designed to supplement the QLQ C30 and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity.
At baseline (Week 0), Weeks 12, 24, 36, 48, and at completion or discontinuation of study treatment (up to approximately 7 years 4 months)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Janssen Research & Development, LLC

Onderzoekers

  • Studie directeur: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 april 2022

Primaire voltooiing (Geschat)

30 maart 2028

Studie voltooiing (Geschat)

24 juli 2029

Studieregistratiedata

Eerst ingediend

30 maart 2022

Eerst ingediend dat voldeed aan de QC-criteria

30 maart 2022

Eerst geplaatst (Werkelijk)

7 april 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CR109115
  • 42756493BLC1003 (Andere identificatie: Janssen Research & Development, LLC)
  • 2021-004144-22 (EudraCT-nummer)
  • 2023-506265-65-00 (Register-ID: EUCT number)
  • 2023 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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