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A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01)

15 września 2026 zaktualizowane przez: Merck Sharp & Dohme LLC

LIGHTBEAM-U01 Substudy 01D: A Phase 1b/2 Substudy to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors

Researchers are looking for new ways to treat children with relapsed or refractory solid tumors:

  • Relapsed means the cancer came back after treatment
  • Refractory means the cancer did not respond (get smaller or go away) to treatment
  • Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids

The study treatment I-DXd (also known as MK-2400 or ifinatamab deruxtecan) is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn:

  • About the safety of I-DXd and if children younger than 12 years old tolerate it
  • How many children who receive I-DXd have the cancer get smaller or go away

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

This study will have 2 parts: Part 1 will evaluate the safety and tolerability and determine the recommended dose for expansion (RDE) of I-DXd, followed by Part 2 an efficacy expansion.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

134

Faza

  • Faza 2
  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Belgia
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgia, 9000
        • Rekrutacyjny
        • UZ Gent ( Site 4428)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +32 9 332 16 53
  • Dania
    • Capital Region
      • Copenhagen, Capital Region, Dania, DK-2100
        • Rekrutacyjny
        • Rigshospitalet ( Site 4467)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +4535455002
  • Francja
    • Aquitaine
      • Bordeaux, Aquitaine, Francja, 33076
        • Rekrutacyjny
        • Bordeaux University Hospital - Pellegrin ( Site 4105)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +33 5 56 79 56 79
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, Francja, 44093
        • Rekrutacyjny
        • Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 4104)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +33240087805
    • Rhone
      • Lyon, Rhone, Francja, 69373
        • Rekrutacyjny
        • CENTRE LEON BERARD ( Site 4100)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +33469166572
  • Hiszpania
      • Barcelona, Hiszpania, 08035
        • Rekrutacyjny
        • Hospital Universitari Vall d Hebron ( Site 4716)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +34934893093
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Hiszpania, 8950
        • Rekrutacyjny
        • Hospital Sant Joan de Déu ( Site 4717)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +34671600093
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Hiszpania, 28009
        • Rekrutacyjny
        • Hospital Niño Jesús ( Site 4715)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +34915035900
  • Izrael
      • Haifa, Izrael, 3109601
        • Rekrutacyjny
        • Rambam Health Care Campus ( Site 4674)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +97247776755
      • Ramat Gan, Izrael, 5265601
        • Rekrutacyjny
        • Sheba Medical Center ( Site 4675)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +97235302996
  • Korea Południowa
      • Seoul, Korea Południowa, 03080
        • Rekrutacyjny
        • Seoul National University Hospital-Pediatrics ( Site 4972)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 82220723304
      • Seoul, Korea Południowa, 05505
        • Rekrutacyjny
        • Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 4973)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 82230105994
  • Stany Zjednoczone
    • California
      • Los Angeles, California, Stany Zjednoczone, 90027
        • Rekrutacyjny
        • Children's Hospital Los Angeles ( Site 4006)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 323-361-2121
    • Colorado
      • Aurora, Colorado, Stany Zjednoczone, 80045
        • Rekrutacyjny
        • Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 4016)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 720-777-6740
    • Iowa
      • Iowa City, Iowa, Stany Zjednoczone, 52242
        • Rekrutacyjny
        • University of Iowa Hospitals ( Site 4017)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 319-356-2296
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02215
        • Rekrutacyjny
        • Dana Farber Cancer Center ( Site 4013)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 617-632-4580
    • Michigan
      • Grand Rapids, Michigan, Stany Zjednoczone, 49503
        • Rekrutacyjny
        • Corewell Health ( Site 4001)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 616-486-0746
    • New Jersey
      • New Brunswick, New Jersey, Stany Zjednoczone, 08901
        • Rekrutacyjny
        • Rutgers Cancer Institute of New Jersey ( Site 4008)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 732-235-2465
    • New York
      • New York, New York, Stany Zjednoczone, 10065
        • Rekrutacyjny
        • Memorial Sloan Kettering Cancer Center ( Site 4010)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 888-492-8401
      • Valhalla, New York, Stany Zjednoczone, 10595
        • Rekrutacyjny
        • New York Medical College ( Site 4023)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 914-614-4270
    • North Dakota
      • Fargo, North Dakota, Stany Zjednoczone, 58102
        • Rekrutacyjny
        • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 4003)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 701-234-2000
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
        • Rekrutacyjny
        • Children's Hospital of Philadelphia (CHOP) ( Site 4021)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 267-425-5544
    • South Dakota
      • Sioux Falls, South Dakota, Stany Zjednoczone, 57105
        • Rekrutacyjny
        • Sanford Children's Hospital ( Site 4015)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 605-312-1000
    • Texas
      • Houston, Texas, Stany Zjednoczone, 77030
        • Rekrutacyjny
        • University of Texas M.D. Anderson Cancer Center ( Site 4007)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 713-792-5410
    • Utah
      • Salt Lake City, Utah, Stany Zjednoczone, 84113
        • Rekrutacyjny
        • Intermountain - Primary Children's Hospital ( Site 4014)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 801-662-4700
  • Szwecja
    • Västra Götaland County
      • Gothenburg, Västra Götaland County, Szwecja, 416 85
        • Rekrutacyjny
        • Sahlgrenska Universitetssjukhuset ( Site 4634)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +46313435865

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko

Akceptuje zdrowych ochotników

Nie

Opis

The main inclusion criteria include but are not limited to the following:

  • In Part 1, participant has recurrent or relapsed, refractory solid tumors (excluding primary central nervous system (CNS)); and in Part 2, participant has recurrent or relapsed, refractory and histologically confirmed diagnosis of osteosarcoma (OST), neuroblastoma (NBL), rhabdomyosarcoma (RMS), or Wilms tumor (WT). All participants must meet the following criteria: Has documented radiological disease progression after at least 1 line of prior therapy in the locally advanced/metastatic setting and who has no satisfactory alternative treatment option (ie, is ineligible for other standard treatment regimens).
  • Is an individual of any sex/gender, ≥1 month to <12 years of age for Part 1 and ≥1 month to <18 years for Part 2 at the time of providing the informed consent or assent, as applicable
  • Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.

The main exclusion criteria include but are not limited to the following:

  • Has clinically significant corneal disease
  • Has a history of cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event within 6 months before screening
  • Has uncontrolled or significant cardiovascular disease, including conduction abnormalities, hypertension, ischemic heart disease, heart failure, and peripheral vascular disease
  • Has any history of interstitial lung disease (ILD)/pneumonitis, irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids, current ILD, or Clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
  • Has clinically severe respiratory compromise resulting from intercurrent pulmonary illnesses
  • Has an active, known or suspected autoimmune disease.
  • Has history of solid organ transplant.
  • Has history of allogeneic stem cell transplant (SCT).
  • Has known active CNS metastases and/or carcinomatous meningitis/leptomeningeal disease/spinal cord compression. Participants with untreated and asymptomatic brain metastases or previously treated brain metastases may participate provided they are radiologically stable, (i.e, without evidence of progression) for at least 4 weeks
  • Has history of human immunodeficiency virus (HIV) infection.
  • Has known additional malignancy that is progressing or has required active treatment within the past 1 year.
  • Has active infection requiring systemic therapy
  • Has known hypersensitivity or contraindication to either the study intervention substance or inactive ingredients in the study intervention product
  • Participants who have not adequately recovered from major surgery or have ongoing surgical complications

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Ifinatamab Deruxtecan
Participants receive ifinatamab deruxtecan via intravenous (IV) infusion on day 1 of each 3-week cycle until discontinuation or progression
Biologiczny: Ifinatamab Deruxtecan
IV infusion
Inne nazwy:
  • DS-7300a
  • I-DXd
  • MK-2400

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Part 1: Number of Participants From ≥1 Month to <12 Years Who Experience a Dose-limiting Toxicity (DLT)
Ramy czasowe: Cycle 1 (up to approximately 21 days); each cycle is 21 days
A DLT is any of a prespecified list of adverse events (AEs) that occur during Cycle 1 (up to 21 days) if attributed to the study treatment and not attributed to any other clearly identifiable cause. The percentage of participants who experience DLTs will be reported. Each cycle is 21 days.
Cycle 1 (up to approximately 21 days); each cycle is 21 days
Part 1: Number of Participants From ≥1 Month to <12 Years Who Experience One or More Adverse Events (AEs)
Ramy czasowe: Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience AEs will be reported.
Up to approximately 5 years
Part 1: Number of Participants From ≥1 Month to <12 Years Who Discontinue Study Intervention Due to an AE
Ramy czasowe: Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 5 years
Part 1: Number of Participants From ≥1 Month to <12 Years Who Receive Dose Modifications Due to AEs
Ramy czasowe: Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who receive dose modification due to an AE will be reported.
Up to approximately 5 years
Part 1 and Part 2: Objective Response Rate (ORR) for Participants with neuroblastoma (NBL), rhabdomyosarcoma (RMS), and Wilms tumor (WT)
Ramy czasowe: Up to approximately 5 years
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Disease Control Success at 4 Months (DCS-4) for Participants with osteosarcoma (OST)
Ramy czasowe: Up to 4 Months
DCS-4 is defined as no occurrence of disease progression per disease specific criteria as assessed by investigator or death due to any cause by Month 4 following the first administration of study intervention for participants with OST. Participants who discontinue from study for any reason prior to completing the third post baseline (or at least 16 weeks) response assessments will be considered disease control failures.
Up to 4 Months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Część 1 i część 2: Całkowite przeżycie (OS)
Ramy czasowe: Do około 5 lat
OS jest definiowany jako czas od pierwszej dawki badanego leczenia do śmierci z powodu jakiejkolwiek przyczyny.
Do około 5 lat
Part 1 and Part 2: Duration of Response (DOR) For Participants With NBL, RMS, WT, or OST
Ramy czasowe: Up to approximately 5 years
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death. PD is defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions is also considered PD. DOR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Disease Control Rate (DCR) For Participants With NBL, RMS, WT, or OST
Ramy czasowe: Up to approximately 5 years
DCR is defined, per RECIST 1.1, as the percentage of participants who have a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD). SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm). Note: The appearance of one or more new lesions is also considered PD. The time from the first dose until the date of SD must be greater than or equal to 6 weeks. The DCR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Time to Response (TTR) For Participants With NBL, RMS, WT, or OST
Ramy czasowe: Up to approximately 5 years
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, TTR is defined as the time from the first dose to the first documented evidence of a CR or PR. The TTR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Progression-free Survival (PFS) For Participants With NBL, RMS, WT, or OST
Ramy czasowe: Up to approximately 5 years
PFS is defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions is also considered PD. PFS as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: ORR For participants with OST
Ramy czasowe: Up to approximately 5 years
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants with OST who experience CR or PR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Number of Participants With NBL, RMS, WT, or OST Who Experience an AE
Ramy czasowe: Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience AEs will be reported.
Up to approximately 5 years
Part 1 and Part 2: Number of Participants With NBL, RMS, WT, or OST Who Discontinue Study Treatment Due to an AE
Ramy czasowe: Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 5 years
Part 1 and Part 2: Number of Participants With NBL, RMS, WT, or OST Who Receive Dose Modification Due to an AE
Ramy czasowe: Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who receive dose modification due to an AE will be reported.
Up to approximately 5 years
Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of I-Dxd
Ramy czasowe: At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the Cmax of I-Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Area under the concentration time curve from Time 0 to the End of the Dosing Period (AUCtau) of I-Dxd
Ramy czasowe: At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the AUCtau of I-Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Plasma Trough Concentration (Ctrough) of I-Dxd
Ramy czasowe: At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the Ctrough of I-Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of released drug payload (Dxd)
Ramy czasowe: At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the Cmax of Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Area under the concentration time curve from Time 0 to the End of the Dosing Period (AUCtau) of Dxd
Ramy czasowe: At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the AUCtau of Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Plasma Trough Concentration (Ctrough) of Dxd
Ramy czasowe: At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the Ctrough of Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Number of Participants with antidrug antibodies (ADA) against I-Dxd
Ramy czasowe: At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to assess I-Dxd immunogenicity by determining the incidence of ADA of I-Dxd.
At designated timepoints (up to approximately 5 years)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Merck Sharp & Dohme LLC

Współpracownicy

Daiichi Sankyo

Śledczy

  • Dyrektor Studium: Medical Director, Merck Sharp & Dohme LLC

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

6 lipca 2026

Zakończenie podstawowe (Szacowany)

17 sierpnia 2031

Ukończenie studiów (Szacowany)

17 sierpnia 2031

Daty rejestracji na studia

Pierwszy przesłany

1 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

1 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

5 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

17 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 9999-01D
  • 2025 (Grant/umowa NIH USA: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • LIGHTBEAM-U01 (Inny identyfikator: MSD)
  • U1111-1322-6561 (Identyfikator rejestru: UTN)
  • 2025-522339-32-00 (Identyfikator rejestru: EU CT)
  • MK-9999-01D (Inny identyfikator: MSD)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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