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En studie som evaluerer effekten, sikkerheten, farmakokinetikken og farmakodynamikken til Crovalimab hos pediatriske deltakere med atypisk hemolytisk uremisk syndrom (aHUS) (COMMUTE-p)

17. august 2026 oppdatert av: Hoffmann-La Roche

En fase III, multisenter, enarmsstudie som evaluerer effektiviteten, sikkerheten, farmakokinetikken og farmakodynamikken til Crovalimab hos pediatriske pasienter med atypisk hemolytisk uremisk syndrom (aHUS)

Denne studien tar sikte på å evaluere effekten og sikkerheten til crovalimab hos pediatriske deltakere med aHUS.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

41

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Belgia
      • Ghent, Belgia, 9000
        • UZ Gent
      • Leuven, Belgia, 3000
        • UZ Leuven Gasthuisberg
  • Brasil
    • São Paulo
      • São Paulo, São Paulo, Brasil, 05403-900
        • Inst. Da Criança- Faculdade de Medicina Usp
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • CHU Sainte-Justine
  • Forente stater
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • Children's Hospital Colorado
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68198
        • University of Nebraska
    • New Jersey
      • Hackensack, New Jersey, Forente stater, 07601
        • Hackensack University Medical Center
  • Frankrike
      • Montpellier, Frankrike, 34295
        • Hopital Arnaud de Villeneuve
      • Paris, Frankrike, 75743
        • Gh Necker Enfants Malades
  • India
    • Gujarat
      • Ahmedabad, Gujarat, India, 380016
        • Institute of Kidney Diseases and Research Centre
    • Haryana
      • Gurgaon, Haryana, India, 122001
        • Medanta-The Medicity
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

4 uker til 17 år (Barn)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Kroppsvekt >= 5 kg ved screening.
  • Vaksinasjon mot Neisseria meningitt serotype A, C, W og Y; vaksinasjon mot serotype B, i henhold til nasjonale vaksinasjonsanbefalinger.
  • Vaksinasjon mot Haemophilus influenzae type B og Streptococcus pneumoniae, i henhold til nasjonale vaksinasjonsanbefalinger.
  • For pasienter som fortsetter å motta andre behandlinger samtidig med crovalimab (f.eks. immunsuppressiva, kortikosteroider, mTORi eller calcineurin-hemmere): stabil dose i >=28 dager før screening og opp til den første crovalimab-administrasjonen.
  • For kvinnelige deltakere i fertil alder: en avtale om å forbli avholdende eller bruke prevensjon.
  • Deltakere med en tidligere nyretransplantasjon er kvalifisert hvis de har en kjent historie med komplementmediert aHUS før nyretransplantasjonen.
  • Start av TMA-presentasjon innen 28 dager før første dose av crovalimab (kun for Naive Cohort).
  • Dokumentert behandling med enten eculizumab eller ravulizumab (kun for Switch Cohort).
  • Klinisk bevis på respons på en C5-hemmer (kun for Switch Cohort).
  • Dårlig kontrollert TMA etter behandling med en annen C5-hemmer (kun for C5 SNP-deltakere i den forhåndsbehandlede kohorten).
  • Kjent C5-polymorfisme (kun for C5 SNP-deltakere i den forbehandlede kohorten).

Ekskluderingskriterier:

  • TMA assosiert med ikke-aHUS-relatert nyresykdom.
  • Positiv direkte Coombs-test.
  • Kronisk dialyse og/eller nyresykdom i sluttstadiet.
  • Identifisert medikamenteksponeringsrelatert TMA.
  • Tilstedeværelse eller historie med en tilstand som kan utløse TMA, som malignitet, benmargs- eller organtransplantasjon (annet enn nyretransplantasjon) eller autoimmun sykdom.
  • Historie om en nyresykdom, annet enn aHUS.
  • Historie med Neisseria meningitidis-infeksjon innen 6 måneder etter studieregistrering.
  • Kjent eller mistenkt immunsvikt (f.eks. historie med hyppige tilbakevendende infeksjoner).
  • Positiv HIV-test.
  • Aktiv systemisk bakteriell, viral eller soppinfeksjon innen 14 dager før første administrering av crovalimab.
  • Tilstedeværelse av feber (>= 38oC) innen 7 dager før første crovalimab-administrasjon.
  • Multisystem organdysfunksjon eller svikt.
  • Nylig IVIg-behandling.
  • Gravid eller ammer eller har tenkt å bli gravid.
  • Deltakelse i en annen intervensjonsbehandlingsstudie med et undersøkelsesmiddel eller bruk av enhver eksperimentell terapi innen 28 dager etter screening eller innen fem halveringstider av det undersøkelsesproduktet, avhengig av hva som er størst.
  • Nylig bruk av tranexamsyre.
  • Nåværende eller tidligere behandling med en komplementhemmer (kun for Naive Cohort).
  • Første initiering av plasmautveksling/plasmainfusjoner (PE/PI) bør ikke være mer enn 28 dager før første crovalimab-administrasjon (kun for Naive Cohort).
  • PE/PI bør ikke administreres innen 6 timer etter første administrering av crovalimab (kun for Naive Cohort).
  • Får PE/PI innen 8 uker etter den første crovalimab-administrasjonen (kun Switch Cohort).
  • Positiv for aktive hepatitt B- og/eller C-infeksjoner (HBV/HCV) (for Switch Cohort og bytte av C5 SNP Pretreated Cohort-deltakere som nylig mottok C5-hemmerbehandling).
  • Kryoglobulinemi ved screening (for deltakere i Switch Cohort og C5 SNP Cohort som nylig mottok C5-hemmerbehandling).
  • Dokumentert tilstand som fører til ikke-aHUS TMA: Trombotisk trombocytopenisk purpura (TTP), Shiga Toxin-produserende Escherichia Coli (STEC)-TMA, Pneumokokk HUS, TMA sekundært til kobalamin C-defekt og TMA relatert til diacylglycerol kinase ε (DGKE) nefropati.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Crovalimab
Deltakerne vil bli registrert i tre kohorter: [1] Naiv kohort - deltakere som ikke tidligere har blitt behandlet med komplementhemmerterapi; [2] Switch Cohort - deltakere som bytter til crovalimab fra en annen C5-hemmer og [3] Pretreated Cohort (inkluderer C5 SNP (Single Nucleotide Polymorphism) deltakere) - deltakere som fikk behandling med en annen C5-hemmer og deretter avsluttet den.
Legemiddel: Crovalimab
Crovalimab vil bli administrert i en dose på 1000 mg intravenøst ​​(IV) (for deltakere som veier => 40 til =100 kg) på uke 1 dag 1. På uke 1 dag 2 og i uke 2, 3 og 4 vil crovalimab administreres i en dose på 340 mg subkutant (SC). I uke 5 og Q4W deretter, vil det bli administrert i en dose på 680 mg SC (for deltakere som veier => 40 til = 100 kg). Påmelding av deltakere som veier =20 kg til =5 kg til

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hoffmann-La Roche

Samarbeidspartnere

Chugai Pharmaceutical

Etterforskere

  • Studieleder: Clinical Trials, Hoffmann-La Roche

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

17. november 2021

Primær fullføring (Faktiske)

4. juli 2025

Studiet fullført (Antatt)

19. mai 2029

Datoer for studieregistrering

Først innsendt

6. juli 2021

Først innsendt som oppfylte QC-kriteriene

6. juli 2021

Først lagt ut (Faktiske)

12. juli 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Kvalifiserte forskere kan be om tilgang til individuelle pasientnivådata gjennom plattformen for forespørsel om kliniske studiedata (www.vivli.org). Ytterligere detaljer om Roches kriterier for kvalifiserte studier er tilgjengelig her (https://vivli.org/ourmember/roche/). For ytterligere detaljer om Roches globale retningslinjer for deling av klinisk informasjon og hvordan du ber om tilgang til relaterte kliniske studiedokumenter, se her (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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