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En undersøgelse, der evaluerer Crovalimabs effektivitet, sikkerhed, farmakokinetik og farmakodynamik hos pædiatriske deltagere med atypisk hæmolytisk uræmisk syndrom (aHUS) (COMMUTE-p)

17. august 2026 opdateret af: Hoffmann-La Roche

En fase III, multicenter, enkeltarmsundersøgelse, der evaluerer effektiviteten, sikkerheden, farmakokinetikken og farmakodynamikken af ​​Crovalimab hos pædiatriske patienter med atypisk hæmolytisk uræmisk syndrom (aHUS)

Denne undersøgelse har til formål at evaluere effektiviteten og sikkerheden af ​​crovalimab hos pædiatriske deltagere med aHUS.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

41

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Ghent, Belgien, 9000
        • UZ Gent
      • Leuven, Belgien, 3000
        • UZ Leuven Gasthuisberg
  • Brasilien
    • São Paulo
      • São Paulo, São Paulo, Brasilien, 05403-900
        • Inst. Da Criança- Faculdade de Medicina Usp
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • CHU Sainte-Justine
  • Forenede Stater
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Children's Hospital Colorado
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68198
        • University of Nebraska
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Hackensack University Medical Center
  • Frankrig
      • Montpellier, Frankrig, 34295
        • Hopital Arnaud de Villeneuve
      • Paris, Frankrig, 75743
        • Gh Necker Enfants Malades
  • Indien
    • Gujarat
      • Ahmedabad, Gujarat, Indien, 380016
        • Institute of Kidney Diseases and Research Centre
    • Haryana
      • Gurgaon, Haryana, Indien, 122001
        • Medanta-The Medicity
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, Indien, 110029
        • All India Institute of Medical Sciences (AIIMS)
  • Japan
      • Aichi, Japan, 474-8710
        • Aichi Children?s Health and Medical Center
      • Chibashi, Chibaken, Japan, 266-0007
        • Chiba Children's Hospital
  • Kina
      • Beijing, Kina, 100034
        • Peking University First Hospital
      • Beijing, Kina, 100045
        • Beijing Children's Hospital, Capital Medical University
      • Hangzhou, Kina, 310051
        • The children's hospital , Zhejiang university school of medicine
  • Mexico
      • Zapopan, Mexico, 45116
        • Hospital de Especialidades Puerta de Hierro S.A de C.V.
  • Polen
      • Gdansk, Polen, 80-294
        • Uniwersyteckie Centrum Kliniczne
      • Lodz, Polen, 93-338
        • Instytut ?Centrum Zdrowia Matki Polki

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

4 uger til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Kropsvægt >= 5 kg ved screening.
  • Vaccination mod Neisseria meningitis serotype A, C, W og Y; vaccination mod serotype B i henhold til nationale vaccinationsanbefalinger.
  • Vaccination mod Haemophilus influenzae type B og Streptococcus pneumoniae i henhold til nationale vaccinationsanbefalinger.
  • For patienter, der fortsætter med at modtage andre behandlinger samtidig med crovalimab (f.eks. immunsuppressiva, kortikosteroider, mTORi eller calcineurinhæmmere): stabil dosis i >=28 dage før screening og op til den første crovalimab-administration.
  • For kvindelige deltagere i den fødedygtige alder: en aftale om at forblive afholdende eller bruge prævention.
  • Deltagere med en tidligere nyretransplantation er kvalificerede, hvis de har en kendt historie med komplementmedieret aHUS før nyretransplantationen.
  • Start af TMA-præsentation inden for 28 dage før den første dosis af crovalimab (kun for Naive Cohort).
  • Dokumenteret behandling med enten eculizumab eller ravulizumab (kun for Switch Cohort).
  • Klinisk dokumentation for respons på en C5-hæmmer (kun for Switch Cohort).
  • Dårligt kontrolleret TMA efter behandling med en anden C5-hæmmer (kun for C5 SNP-deltagere i den forbehandlede kohorte).
  • Kendt C5 polymorfi (kun for C5 SNP deltagere i den forbehandlede kohorte).

Ekskluderingskriterier:

  • TMA forbundet med ikke-aHUS-relateret nyresygdom.
  • Positiv direkte Coombs-test.
  • Kronisk dialyse og/eller nyresygdom i slutstadiet.
  • Identificeret lægemiddeleksponeringsrelateret TMA.
  • Tilstedeværelse eller historie af en tilstand, der kan udløse TMA, såsom malignitet, knoglemarvs- eller organtransplantation (bortset fra nyretransplantation) eller autoimmun sygdom.
  • Anamnese med en nyresygdom, bortset fra aHUS.
  • Anamnese med Neisseria meningitidis-infektion inden for 6 måneder efter tilmelding til studiet.
  • Kendt eller mistænkt immundefekt (f.eks. historie med hyppige tilbagevendende infektioner).
  • Positiv HIV-test.
  • Aktiv systemisk bakteriel, viral eller svampeinfektion inden for 14 dage før første indgivelse af crovalimab.
  • Tilstedeværelse af feber (>= 38oC) inden for 7 dage før den første indgivelse af crovalimab.
  • Multi-system organ dysfunktion eller svigt.
  • Nylig IVIg-behandling.
  • Gravid eller ammer eller har til hensigt at blive gravid.
  • Deltagelse i en anden interventionel behandlingsundersøgelse med et forsøgsmiddel eller brug af enhver eksperimentel terapi inden for 28 dage efter screening eller inden for fem halveringstider af det pågældende forsøgsprodukt, alt efter hvad der er størst.
  • Nylig brug af tranexamsyre.
  • Nuværende eller tidligere behandling med en komplementhæmmer (kun for Naive Cohort).
  • Første påbegyndelse af plasmaudveksling/plasmainfusioner (PE/PI) bør ikke være mere end 28 dage før første indgivelse af crovalimab (kun for Naive Cohort).
  • PE/PI bør ikke administreres inden for 6 timer efter første indgivelse af crovalimab (kun for Naive Cohort).
  • Modtagelse af PE/PI inden for 8 uger efter den første indgivelse af crovalimab (kun skiftkohorte).
  • Positiv for aktive hepatitis B- og/eller C-infektioner (HBV/HCV) (for Switch Cohort og skiftende C5 SNP Pretreated Cohort deltagere, som for nylig har modtaget C5-hæmmerbehandling).
  • Kryoglobulinæmi ved screening (for deltagere i Switch Cohort og C5 SNP Cohort, som for nylig modtog C5-hæmmerbehandling).
  • Dokumenteret tilstand, der fører til non-aHUS TMA: Trombotisk trombocytopenisk purpura (TTP), Shiga Toxin-producerende Escherichia Coli (STEC)-TMA, Pneumokok HUS, TMA sekundært til cobalamin C-defekt og TMA relateret til diacylglycerol kinase ε (DGKE) nefropati.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Crovalimab
Deltagerne vil blive indskrevet i tre kohorter: [1] Naiv kohorte - deltagere, der ikke tidligere er blevet behandlet med komplementhæmmerterapi; [2] Switch Cohort - deltagere, der skifter til crovalimab fra en anden C5-hæmmer og [3] Pretreated Cohort (inkluderer C5 SNP (Single Nucleotide Polymorphism) deltagere) - deltagere, der modtog behandling med en anden C5-hæmmer og efterfølgende afbrød den.
Medicin: Crovalimab
Crovalimab vil blive administreret i en dosis på 1000 mg intravenøst ​​(IV) (for deltagere, der vejer => 40 til = 100 kg) på uge 1 dag 1. På uge 1 dag 2 og i uge 2, 3 og 4 vil crovalimab blive administreret i en dosis på 340 mg subkutant (SC). I uge 5 og Q4W derefter vil det blive administreret i en dosis på 680 mg SC (for deltagere, der vejer => 40 til = 100 kg). Tilmelding af deltagere, der vejer =20 kg til =5 kg til

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Naïve Cohort: Percentage of Participants With Complete Thrombotic Microangiopathy Response (cTMAr) Anytime From Baseline to Week 25 (After 24 Weeks on Treatment)
Tidsramme: From baseline up to Week 25
cTMAr was defined by meeting all of the following criteria at two separate assessments, obtained at least 4 weeks (a minimum of 26 days) apart, and any measurement in between: Platelet count ≥ lower limit of normal (LLN); Lactate dehydrogenase (LDH) ≤ upper limit of normal (ULN); and ≥ 25% decrease in serum creatinine from baseline. Participants with normalized creatinine (i.e., LLN ≤ creatinine ≤ ULN) at baseline were excluded from analysis. 95% confidence interval (CI) was calculated using Wilson's score method. Percentage has been rounded off.
From baseline up to Week 25

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Naïve and Switch Cohorts: Percentage of Participants Requiring Dialysis at Baseline or Week 25 and Who Completed 24 Weeks of Treatment
Tidsramme: Baseline and Week 25
Participants were considered to be on dialysis at baseline or at Week 25 if dialysis occurred within 5 days prior to the first crovalimab administration or prior to the end date of the primary treatment period, respectively. The percentage of participants who required dialysis at baseline and Week 25 has been reported here. Percentages have been rounded off.
Baseline and Week 25
Naïve and Switch Cohorts: Percentage of Participants With Change From Baseline to Week 25 (After 24 Weeks on Treatment) on Dialysis Status (Yes/No)
Tidsramme: From baseline up to Week 25
Participants were considered as being on dialysis at baseline or at Week 25 if dialysis occurred within 5 days prior to the first crovalimab administration or prior to the end date of the primary treatment period, respectively. Percentages have been rounded off.
From baseline up to Week 25
Naïve and Switch Cohorts: Observed Value of Estimated Glomerular Filtration Rate (eGFR), as Calculated From Central Serum Creatinine
Tidsramme: Baseline, Weeks 2, 3, 4, 5, 7, 9, 11, 13, 17, 21, and 25
GFR is an index of kidney function that describes the flow rate of filtered fluid through the kidneys. It was categorized according to chronic kidney disease (CKD) staging criteria. eGFR was calculated using the creatinine-based bedside Schwartz equation. eGFR (milliliters per minute per 1.73 square meter [mL/min/1.73 m^2])=0.413*(height [ht]/serum creatinine [sCr]), if height is expressed in centimeters, or 41.3*(ht/sCr), if height is expressed in meters.
Baseline, Weeks 2, 3, 4, 5, 7, 9, 11, 13, 17, 21, and 25
Naïve and Switch Cohorts: Change From Baseline to Week 25 in eGFR, as Calculated From Central Serum Creatinine
Tidsramme: Baseline, Weeks 2, 3, 4, 5, 7, 9, 11, 13, 17, 21, and 25
GFR is an index of kidney function that describes the flow rate of filtered fluid through the kidneys. It was categorized according to CKD staging criteria. eGFR was calculated using the creatinine-based bedside Schwartz equation. eGFR (mL/min/1.73 m^2])=0.413*(ht/sCr), if height is expressed in centimeters, or 41.3*(ht/sCr), if height is expressed in meters.
Baseline, Weeks 2, 3, 4, 5, 7, 9, 11, 13, 17, 21, and 25
Naïve and Switch Cohorts: Percentage of Participants With Change From Baseline to Week 25 (After 24 Weeks on Treatment) in CKD Stage, as Assessed Based on eGFR Calculated From Central Serum Creatinine
Tidsramme: From baseline up to Week 25
CKD stage was assessed using eGFR, calculated from central serum creatinine using Creatinine-based bedside Schwartz equation & classified according to National Kidney Foundation CKD staging criteria as follows: G1 (≥90 mL/min/1.73 m²; normal or high kidney function), G2 (60-89 mL/min/1.73 m²; mildly decreased kidney function), G3a (45-59 mL/min/1.73 m²; mildly to moderately decreased kidney function), G3b (30-44 mL/min/1.73 m²; moderately to severely decreased kidney function), G4 (15-29 mL/min/1.73 m²; severely decreased kidney function), & G5 (<15 mL/min/1.73 m²; kidney failure). Change in CKD stage from baseline to Week 25 was categorized as improved (participants who improved in CKD stage from Baseline to Week 25 were based on the number of participants who completed 24 weeks and were not Stage 1 at baseline), stable (no change), or worsened (participants with CKD Stage 1 to 4 at baseline) among participants who completed 24 weeks of treatment. Percentages have been rounded off.
From baseline up to Week 25
Naïve and Switch Cohorts: Observed Value of Platelet Count
Tidsramme: Baseline and Week 25
Baseline and Week 25
Naïve and Switch Cohorts: Observed Value of LDH
Tidsramme: Baseline and Week 25
Baseline and Week 25
Naïve and Switch Cohorts: Observed Value of Hemoglobin (Hb)
Tidsramme: Baseline and Week 25
Baseline and Week 25
Naïve and Switch Cohorts: Change From Baseline to Week 25 (After 24 Weeks on Treatment) in Platelet Count
Tidsramme: Baseline and Week 25
Baseline and Week 25
Naïve and Switch Cohorts: Change From Baseline to Week 25 (After 24 Weeks on Treatment) in LDH
Tidsramme: Baseline and Week 25
Baseline and Week 25
Naïve and Switch Cohorts: Change From Baseline to Week 25 (After 24 Weeks on Treatment) in Hb
Tidsramme: Baseline and Week 25
Baseline and Week 25
Naïve Cohort: Percentage of Participants With Platelet Count ≥ LLN at Two Separate Assessments, Obtained at Least 4 Weeks Apart (Minimum of 26 Days), by Week 25 (After 24 Weeks on Treatment)
Tidsramme: From baseline up to Week 25
This event was confirmed at two separate assessments obtained at least 4 weeks (a minimum of 26 days) apart and any measurement in between.
From baseline up to Week 25
Naïve Cohort: Percentage of Participants With LDH Normalization (i.e., ≤ ULN) at Two Separate Assessments, Obtained at Least 4 Weeks Apart (Minimum of 26 Days), by Week 25 (After 24 Weeks on Treatment)
Tidsramme: From baseline up to Week 25
Percentage has been rounded off.
From baseline up to Week 25
Naïve Cohort: Percentage of Participants With ≥ 25% Decrease in Serum Creatinine From Baseline, Confirmed at Two Separate Assessments, Obtained at Least 4 Weeks Apart (Minimum of 26 Days), by Week 25 (After 24 Weeks on Treatment)
Tidsramme: From baseline up to Week 25
Percentage has been rounded off.
From baseline up to Week 25
Naïve Cohort: Time to cTMAr
Tidsramme: From baseline up to Week 25
cTMAr was defined by meeting all of the following criteria at two separate assessments, obtained at least 4 weeks (a minimum of 26 days) apart, and any measurement in between: Platelet count ≥ LLN; LDH ≤ ULN; and ≥ 25% decrease in serum creatinine from baseline. Kalpan-Meier (K-M) method was used to estimate median time to cTMAr. Data for participants who did not reach cTMAr during PTP were censored at the date of their last visit when cTMAr was assessed during the primary treatment period or prior to the treatment discontinuation, whichever was earlier. Data for participants who received a prohibited therapy during the PTP were censored at the date of the first received prohibited therapy during the primary treatment period or prior to the treatment discontinuation, whichever was earlier.
From baseline up to Week 25
Naïve Cohort: Duration of cTMAr, Among Participants Who Achieved cTMAr
Tidsramme: From baseline up to primary CCOD (up to 190 weeks)
cTMAr=meeting following criteria at 2 separate assessments, obtained at least 4 weeks (minimum of 26 days) apart & any measurement in between: Platelet count ≥LLN; LDH ≤ULN; & ≥25% decrease in serum creatinine from baseline. Duration of cTMAr was calculated as time from start of cTMAr to end of cTMAr. End of cTMAr=when all of following criteria were met during same visit & confirmed at assessment that took place at least 4 weeks (minimum of 26 days) later: Platelet count <LLN; LDH >ULN; & ≥25% increase in serum creatinine from baseline & ULN. K-M method was used to estimate the median duration of cTMAr. Data for participants with no observed end of cTMAr at CCOD were censored at the date of their last visit when cTMAr was assessed before CCOD or before treatment discontinuation, whichever was earlier. Data for participants who received prohibited therapy before CCOD were censored at date of first receiving prohibited therapy or before treatment discontinuation, whichever was earlier.
From baseline up to primary CCOD (up to 190 weeks)
Naïve Cohort: Percentage of Participants With cTMAr Ongoing at Week 25
Tidsramme: At Week 25
cTMAr at Week 25 was defined by meeting all of the three cTMAr criteria at Week 25: Platelet count ≥ LLN; LDH ≤ ULN; and ≥ 25% decrease in serum creatinine from baseline. Percentage has been rounded off.
At Week 25
Switch Cohort: Percentage of Participants With Maintained Thrombotic Microangiopathy Response Control (mTMAc) From Baseline Through Week 25 (After 24 Weeks on Treatment)
Tidsramme: From baseline up to Week 25
mTMAc was considered not maintained if all of the following criteria were met during one of the visits between baseline and Week 25, and were confirmed at an assessment that took place at least 4 weeks (a minimum of 26 days) later: Platelet count < LLN; LDH > ULN; and 25% increase in serum creatinine from baseline.
From baseline up to Week 25
All Cohorts: Number of Participants With Adverse Events (AEs)
Tidsramme: Up to approximately 8 years
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Up to approximately 8 years
All Cohorts: Number of Participants With Injection-site Reactions, Infusion-related Reactions, Hypersensitivity, Malignant Hypertension (Including Malignant Renal Hypertension), and Infections (Including Meningococcal Meningitis)
Tidsramme: Up to approximately 8 years
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Up to approximately 8 years
All Cohorts: Number of Participants With AEs Leading to Study Drug Discontinuation
Tidsramme: Up to approximately 8 years
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Up to approximately 8 years
Switch Cohort: Number of Participants With Clinical Manifestations of Drug-target-drug Complexes (DTDCs)
Tidsramme: Up to approximately 8 years
Crovalimab and eculizumab bind distinct epitopes on complement component C5, and formation of DTDCs comprising crovalimab, eculizumab, and C5 are formed when participants switch treatment. DTDCs will be characterized using size exclusion chromatography (SEC) coupled with enzyme-linked immunosorbent assay (ELISA).
Up to approximately 8 years
All Cohorts: Serum Concentrations of Crovalimab Over Time
Tidsramme: Up to approximately 8 years
Up to approximately 8 years
All Cohorts: Number of Participants With Anti-drug Antibodies (ADAs) to Crovalimab
Tidsramme: Up to approximately 8 years
Participants will be considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following stuy drug exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples is at least 4-fold greater than the titer of the baseline sample (treatment-enhanced ADA response).
Up to approximately 8 years
All Cohorts: Observed Value of Total Complement Activity 50 (CH50), as Measured by Liposome Immunoassay (LIA)
Tidsramme: Up to approximately 8 years
Up to approximately 8 years
All Cohorts: Change From Baseline in CH50 Over Time, as Measured by LIA
Tidsramme: Up to approximately 8 years
Up to approximately 8 years
All Cohorts: Observed Value of Free Complement Component 5 (C5) Concentrations in Crovalimab-treated Participants
Tidsramme: Up to approximately 8 years
Up to approximately 8 years
All Cohorts: Change From Baseline in Free C5 Concentrations Over Time in Crovalimab-treated Participants
Tidsramme: Up to approximately 8 years
Up to approximately 8 years
All Cohorts: Observed Value of Total C5 Concentrations in Crovalimab-treated Participants
Tidsramme: Up to approximately 8 years
Up to approximately 8 years
All Cohorts: Change From Baseline in Total C5 Concentrations Over Time in Crovalimab-treated Participants
Tidsramme: Up to approximately 8 years
Up to approximately 8 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Samarbejdspartnere

Chugai Pharmaceutical

Efterforskere

  • Studieleder: Clinical Trials, Hoffmann-La Roche

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. november 2021

Primær færdiggørelse (Faktiske)

4. juli 2025

Studieafslutning (Anslået)

19. maj 2029

Datoer for studieregistrering

Først indsendt

6. juli 2021

Først indsendt, der opfyldte QC-kriterier

6. juli 2021

Først opslået (Faktiske)

12. juli 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BO42354
  • 2023 (U.S. NIH-bevilling/kontrakt: GRAMMY Museum Foundation)
  • 2020-002437-15 (EudraCT nummer)
  • 2023-505638-82-00 (Ctis)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Kvalificerede forskere kan anmode om adgang til data på individuelt patientniveau via platformen for anmodninger om kliniske undersøgelsesdata (www.vivli.org). Yderligere detaljer om Roches kriterier for kvalificerede undersøgelser er tilgængelige her (https://vivli.org/ourmember/roche/). For yderligere detaljer om Roches globale politik om deling af klinisk information og hvordan man anmoder om adgang til relaterede kliniske undersøgelsesdokumenter, se her (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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