HOPE in Action Prospektivt multicenter, klinisk forsøg med afdøde HIVD+ nyretransplantationer til HIV+-modtagere
1. september 2026 opdateret af: Johns Hopkins University
Det primære formål med denne undersøgelse er at afgøre, om en HIV-inficeret afdød nyredonor (HIVD+) transplantation er sikker med hensyn til større transplantationsrelaterede og HIV-relaterede komplikationer.
Studieoversigt
Detaljeret beskrivelse
Denne undersøgelse vil evaluere, om det er sikkert at modtage en nyretransplantation fra en HIV-inficeret afdød nyredonor med hensyn til overlevelse og større transplantationsrelaterede og HIV-relaterede komplikationer sammenlignet med at modtage en nyre fra en HIV-uinficeret afdød nyredonor (HIVD-) .
De deltagere, der har accepteret et HIVD-organ, vil blive randomiseret til at blive fulgt i hele undersøgelsen eller fulgt i den indlejrede observationsgruppe.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
207
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294
- University of Alabama at Birmingham
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- University of Arkansas for Medical Sciences
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California
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Los Angeles, California, Forenede Stater, 90095
- University of California, Los Angeles
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San Diego, California, Forenede Stater, 92103
- University of California, San Diego
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San Francisco, California, Forenede Stater, 94193
- University of California, San Francisco
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06520-8022
- Yale University School Of Medicine
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20007
- MedStar Georgetown Transplant Institute
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Florida
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Miami, Florida, Forenede Stater, 33136
- Miami Transplant Institute
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Weston, Florida, Forenede Stater, 33331
- Cleveland Clinic Florida
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Emory University
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- University of Illinois at Chicago
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern University
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Chicago, Illinois, Forenede Stater, 60612
- Rush University Medical Center
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- Indiana University
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70121
- Ochsner Medical Center
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Maryland
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Baltimore, Maryland, Forenede Stater, 21205
- Johns Hopkins University
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Baltimore, Maryland, Forenede Stater, 212101
- University of Maryland, Institute of Human Virology
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
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New York
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New York, New York, Forenede Stater, 10032
- Columbia University Medical Center
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New York, New York, Forenede Stater, 10065
- Weill Cornell Medical College
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New York, New York, Forenede Stater, 10016
- New York University School of Medicine
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New York, New York, Forenede Stater, 10029
- Icahn School of Medicine at Mount Sinai
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45267
- University of Cincinnati
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19102
- Drexel University
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- UPMC-University of Pittsburgh Medical Center
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Texas
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Dallas, Texas, Forenede Stater, 75390
- University of Texas Southwestern Medical Center
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Dallas, Texas, Forenede Stater, 75203
- Methodist Health System Clinical Research Institute
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
- University of Virginia
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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
14 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Deltager opfylder standardkriterierne for nyretransplantation på lokalcentret.
- Deltageren er i stand til at forstå og give informeret samtykke.
- Deltageren mødes med en uafhængig fortaler i henhold til HIV Organ Policy Equity (HOPE) Act Safeguards.
- Dokumenteret HIV-infektion (ved enhver licenseret analyse eller dokumenteret historie med påviselig HIV-1 RNA).
- Ingen levende donor tilgængelig.
- Deltageren er ≥18 år.
- Opportunistiske komplikationer: hvis tidligere en opportunistisk infektion i anamnesen, har deltageren modtaget passende behandling og har ingen tegn på aktiv sygdom.
- Cluster of Differentiation 4 (CD4)+ T-celle: ≥200/µL inden for 16 uger efter transplantation.
- HIV-1 er under 50 kopier RNA/ml. Virale blips mellem 50-400 kopier tilladt, så længe der ikke er fortløbende mål >200 kopier/ml.
- Deltageren er villig til at overholde al medicin relateret til deres transplantation og HIV-håndtering.
- For deltagere med en historie med aspergillus kolonisering eller sygdom, ingen tegn på aktiv sygdom.
- Deltageren skal have, eller være villig til at begynde at se, en primær læge med ekspertise i hiv-håndtering.
- Alle deltagere, der deltager i seksuel aktivitet, der kan føre til graviditet, skal bruge en FDA-godkendt præventionsmetode.
- Deltageren lider ikke af væsentligt spild (f.eks. BMI
Ekskluderingskriterier:
- Deltageren har en historie med progressiv multifokal leukoencefalopati (PML) eller primært centralnervesystem (CNS) lymfom.
- Deltageren er gravid eller ammer.
- Tidligere eller nuværende medicinske problemer eller fund fra sygehistorie, fysisk undersøgelse eller laboratorieundersøgelser, som ikke er nævnt ovenfor, som efter investigatorens mening kan udgøre yderligere risici eller kan påvirke kvaliteten eller fortolkningen af de data, der er opnået fra undersøgelsen.
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: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: HIV D-/R+ (observations)
HIV-inficerede individer, der accepterer et organ fra en HIV-ikke-inficeret afdød donor og randomiseret til observationsgruppe - tilmelding 200
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Eksperimentel: HIV D+/R+
HIV-inficerede personer, der accepterer et organ fra en HIV-inficeret afdød donor - tilmelding 100
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Nyre fra en HIV-smittet afdød donor
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Ingen indgriben: HIV D-/R+
HIV-inficerede individer, der accepterer et organ fra en HIV-ikke-inficeret afdød donor - tilmelding 100
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Composite Event, Time to First Death or Graft Failure or Serious Adverse Event (SAE) or HIV Breakthrough or Opportunistic Infection
Tidsramme: From date of transplant through administrative censorship at study completion, up to 4 years
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Time to first of any of the following events: death or graft failure or serious adverse event (SAE) or HIV breakthrough or HIV virologic failure or opportunistic infection
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From date of transplant through administrative censorship at study completion, up to 4 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Pre-transplant Mortality
Tidsramme: At 1 and 2 years post-consent, prior to transplant
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Cumulative incidence of mortality while enrolled before transplant
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At 1 and 2 years post-consent, prior to transplant
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Graft Failure
Tidsramme: At 1 and 3 years post transplant
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Cumulative incidence of graft failure
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At 1 and 3 years post transplant
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Rate of Serious Adverse Events
Tidsramme: From date of transplant through graft failure or administrative censorship at study completion, up to year 4
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Count of post-transplant serious adverse events per person-year as assessed by Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0
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From date of transplant through graft failure or administrative censorship at study completion, up to year 4
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6-month Acute Rejection
Tidsramme: At 6 months post-transplant
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Percentage of recipients who experience acute rejection as measured by biopsy using Banff 2015 criteria: Borderline changes: 'Suspicious' for acute T-cell mediated rejection.This category is used when no intimal arteritis is present, but there are foci of mild tubulitis (t1, t2, or t3) with minor interstitial infiltration (i0 or i1) or interstitial infiltration (i2, i3) with mild (t1) tubulitis.
Acute T-cell mediated rejection:Grade from IA defined as cases with significant interstitial infiltration (>25% of parenchyma affected, i2 or i3) and foci of moderate tubulitis (t2) to III defined as cases with 'transmural' arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation (v3).
Outcome data of the observational group were obtained from the Scientific Registry of Transplant Recipients (September 2023 data export).
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At 6 months post-transplant
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1-year Acute Rejection
Tidsramme: From date of transplant to end of year 1
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Percentage of recipients who experience acute rejection as measured by biopsy using Banff 2015 criteria: Borderline changes: 'Suspicious' for acute T-cell mediated rejection.This category is used when no intimal arteritis is present, but there are foci of mild tubulitis (t1, t2, or t3) with minor interstitial infiltration (i0 or i1) or interstitial infiltration (i2, i3) with mild (t1) tubulitis.
Acute T-cell mediated rejection:Grade from IA defined as cases with significant interstitial infiltration (>25% of parenchyma affected, i2 or i3) and foci of moderate tubulitis (t2) to III defined as cases with 'transmural' arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation (v3).
Outcome data of the observational group were obtained from the Scientific Registry of Transplant Recipients (September 2023 data export).
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From date of transplant to end of year 1
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Incidence of Graft Rejection
Tidsramme: At 1 and 3 years post transplant
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Cumulative incidence of acute rejection as measured by biopsy using Banff 2015 criteria: Borderline changes: 'Suspicious' for acute T-cell mediated rejection.This category is used when no intimal arteritis is present, but there are foci of mild tubulitis (t1, t2, or t3) with minor interstitial infiltration (i0 or i1) or interstitial infiltration (i2, i3) with mild (t1) tubulitis.
Acute T-cell mediated rejection:Grade from IA defined as cases with significant interstitial infiltration (>25% of parenchyma affected, i2 or i3) and foci of moderate tubulitis (t2) to III defined as cases with 'transmural' arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation (v3).
Outcome data of the observational group were obtained from the Scientific Registry of Transplant Recipients (September 2023 data export).
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At 1 and 3 years post transplant
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Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2
Tidsramme: At 3 months post-transplant
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Number of transplant recipients with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) < 60 mL/min/1.73
m2
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At 3 months post-transplant
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Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2
Tidsramme: At 6 months post-transplant
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Number of transplant recipients with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) <60 mL/min/1.73
m^2
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At 6 months post-transplant
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Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2
Tidsramme: 9 months post-transplant
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Number of transplant recipients with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) <60 mL/min/1.73
m^2
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9 months post-transplant
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Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2
Tidsramme: At year 1 post-transplant
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Number of transplant recipients with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) <60 mL/min/1.73
m^2
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At year 1 post-transplant
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Graft Function Number of Participants With eGRF<60 mL/Min/1.73 m^2
Tidsramme: At year 2 post-transplant
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Percentage of participants with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) <60 mL/min/1.73
m^2
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At year 2 post-transplant
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Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2
Tidsramme: At year 3 post-transplant
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Percentage of participants with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) <60 mL/min/1.73
m^2
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At year 3 post-transplant
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Graft Function -Mean eGFR
Tidsramme: 3 months post-transplant
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Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
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3 months post-transplant
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Graft Function-mean eGFR
Tidsramme: 6 months post-transplant
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Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
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6 months post-transplant
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Graft Function-mean eGFR
Tidsramme: 9 months post-transplant
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Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
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9 months post-transplant
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Graft Function-mean eGFR
Tidsramme: 1 year post-transplant
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Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
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1 year post-transplant
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Graft Function-mean eGFR
Tidsramme: 2 years post-transplant
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Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
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2 years post-transplant
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Graft Function-mean eGFR
Tidsramme: 3 years post-transplant
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Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
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3 years post-transplant
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Graft Function - Slope eGFR
Tidsramme: From date of transplant to end of follow-up, up to 4 years
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The slope of glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) over time (longitudinal analysis)
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From date of transplant to end of follow-up, up to 4 years
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Donor and Recipient Apolipoprotein L1 (APOL1)
Tidsramme: Baseline
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Percentage of transplant recipients with at least 1 apolipoprotein L1 (APOL1) risk variant in donor and recipient
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Baseline
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Participants With Undetectable HIV RNA
Tidsramme: From date of transplant through end of follow-up, up to 4 years
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Trajectory of recipient plasma HIV RNA over time.
Analysis of repeated measures of plasma HIV RNA (longitudinal model).
Below 50 copies/mL was used as the threshold of undetectable HIV RNA.
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From date of transplant through end of follow-up, up to 4 years
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Trajectory of Recipient Cluster of Differentiation (CD4) Count Over Time
Tidsramme: From date of transplant through end of follow up, up to 4 years
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Analysis of repeated measures of Cluster of Differentiation 4 (CD4) count (longitudinal model)
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From date of transplant through end of follow up, up to 4 years
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Incidence of Antiretroviral Resistance
Tidsramme: From date of transplant through end of follow-up, up to 4 years
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Measured by local sites' Clinical Laboratory Improvement Amendments (CLIA) certified lab with episode of HIV breakthrough defined as 2 consecutive plasma HIV viral loads >200 copies/mL or one HIV viral load >1000 copies/mL after a period of virologic control post-transplant
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From date of transplant through end of follow-up, up to 4 years
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Incidence of X4 Tropic Virus
Tidsramme: From date of transplant through end of follow-up, up to 4 years
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Measured by local sites' Clinical Laboratory Improvement Amendments (CLIA) certified lab with episode of HIV breakthrough defined as 2 consecutive plasma HIV viral loads >200 copies/mL or one HIV viral load >1000 copies/mL after a period of virologic control post-transplant
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From date of transplant through end of follow-up, up to 4 years
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Incidence of Opportunistic Infection
Tidsramme: From date of transplant through end of follow-up, up to 4 years
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Cumulative incidence of opportunistic infections
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From date of transplant through end of follow-up, up to 4 years
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Incidence of Surgical Complications
Tidsramme: From date of transplant through year 1
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Number of surgical complications within 1 year of transplant, e.g.
delayed closure, wound dehiscence
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From date of transplant through year 1
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Incidence of Vascular Complications
Tidsramme: From date of transplant through year 1
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Number of vascular complications within 1 year of transplant
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From date of transplant through year 1
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Incidence of Viral-related Malignancies
Tidsramme: From date of transplant through end of follow-up, up to 4 years
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Number of malignancies as determined by local pathology
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From date of transplant through end of follow-up, up to 4 years
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Participants With Formation of de Novo Donor-specific Human Leukocyte Antigen(HLA) Antibodies
Tidsramme: From date of transplant through end of year 1
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Participants must have donor-specific HLA data at both day 0 and at 1 year to be included in the analysis.
A total of 32 HIV D+/R+ and 40 HIV D-/R+ participants were excluded due to missing donor-specific data at either day 0 or 1 year.
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From date of transplant through end of year 1
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Composite Event, Cumulative Incidence
Tidsramme: At 6 months, 1 and 3 years post-transplant
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Cumulative incidence of the composite event, which is defined as the occurrence of first event of any of all-cause-mortality or graft failure or renal allograft rejection or HIV breakthrough or HIV virologic failure or AIDS defining illness
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At 6 months, 1 and 3 years post-transplant
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Christine Durand, MD, Johns Hopkins University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Werbel WA, Brown DM, Kusemiju OT, Doby BL, Seaman SM, Redd AD, Eby Y, Fernandez RE, Desai NM, Miller J, Bismut GA, Kirby CS, Schmidt HA, Clarke WA, Seisa M, Petropoulos CJ, Quinn TC, Florman SS, Huprikar S, Rana MM, Friedman-Moraco RJ, Mehta AK, Stock PG, Price JC, Stosor V, Mehta SG, Gilbert AJ, Elias N, Morris MI, Mehta SA, Small CB, Haidar G, Malinis M, Husson JS, Pereira MR, Gupta G, Hand J, Kirchner VA, Agarwal A, Aslam S, Blumberg EA, Wolfe CR, Myer K, Wood RP, Neidlinger N, Strell S, Shuck M, Wilkins H, Wadsworth M, Motter JD, Odim J, Segev DL, Durand CM, Tobian AAR; HOPE in Action Investigators. National Landscape of Human Immunodeficiency Virus-Positive Deceased Organ Donors in the United States. Clin Infect Dis. 2022 Jun 10;74(11):2010-2019. doi: 10.1093/cid/ciab743.
- Sulaiman A, Tamil Selvan M, Yang P, Zhu X, Eby Y, Benner SE, Fernandez RE, Hussain S, Brown D, Desai N, Florman S, Rana MM, Friedman-Moraco R, Pereira MR, Mehta S, Stock P, Gilbert A, Morris MI, Stosor V, Mehta SA, Small CB, Ranganna K, Santos CAQ, Aslam S, Malinis M, Elias N, Blumberg EA, Massie A, Smith ML, Morsheimer M, Laird GM, Siliciano R, Segev DL, Durand CM, Redd AD, Tobian AA. Allograft Rejection and the Latent HIV Reservoir in Kidney Transplant Recipients with HIV. J Infect Dis. 2026 Mar 13:jiag154. doi: 10.1093/infdis/jiag154. Online ahead of print.
- Zhu X, Morgenlander WR, Brown DM, Eby Y, Morsheimer M, Odim J, Bagnasco SM, Rana MM, Florman SS, Friedman-Moraco RJ, Stock PG, Gilbert AJ, Mehta S, Stosor V, Mehta SA, Pereira MR, Small CB, Morris MI, Hand J, Aslam S, Haidar G, Malinis M, Santos CA, Schaenman J, Wojciechowski D, Ranganna K, Blumberg E, Elias N, Castillo-Lugo JA, Giorgakis E, Apewokin S, Grabowski MK, Segev DL, Redd AD, Durand CM, Larman HB, Tobian AA; HOPE in Action investigators. Human antibody repertoire among kidney donors with and without HIV. JCI Insight. 2026 Mar 12;11(8):e203645. doi: 10.1172/jci.insight.203645. eCollection 2026 Apr 22.
- Freercks R, Rodrigues M, Manning K, Heymann J, Kopp JB, Nagiah S, Rana M, Florman S, Friedman-Moraco R, Stock P, Gilbert A, Mehta S, Stosor V, Pereira MR, Morris MI, Hand J, Haidar G, Malinis M, Santos CAQ, Schaenman J, Blumberg EA, Wojciechowski D, Odim J, Massie A, Selvan MT, Bagnasco S, Segev D, Tobian AAR, Muller E, Durand CM, Redd AD. APOL1 Genotype and Patient Outcomes in US and South African Transplant Recipients With HIV who Received Kidneys From Donors With HIV. Transplantation. 2026 Apr 1;110(4):e897-e904. doi: 10.1097/TP.0000000000005556. Epub 2025 Nov 17.
- Durand CM, Massie A, Florman S, Liang T, Rana MM, Friedman-Moraco R, Gilbert A, Stock P, Mehta SA, Mehta S, Stosor V, Pereira MR, Morris MI, Hand J, Aslam S, Malinis M, Haidar G, Small CB, Santos CAQ, Schaenman J, Baddley J, Wojciechowski D, Blumberg EA, Ranganna K, Adebiyi O, Elias N, Castillo-Lugo JA, Giorgakis E, Apewokin S, Brown D, Ostrander D, Eby Y, Desai N, Naqvi F, Bagnasco S, Watson N, Brittain E, Odim J, Redd AD, Tobian AAR, Segev DL; HOPE in Action Investigators. Safety of Kidney Transplantation from Donors with HIV. N Engl J Med. 2024 Oct 17;391(15):1390-1401. doi: 10.1056/NEJMoa2403733.
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)
19. april 2018
Primær færdiggørelse (Faktiske)
30. september 2022
Studieafslutning (Faktiske)
1. maj 2024
Datoer for studieregistrering
Først indsendt
2. april 2018
Først indsendt, der opfyldte QC-kriterier
12. april 2018
Først opslået (Faktiske)
18. april 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Blodbårne infektioner
- Urogenitale sygdomme
- Genitale sygdomme
- Sygdomme i immunsystemet
- Infektioner
- RNA-virusinfektioner
- Virussygdomme
- Overførbare sygdomme
- Seksuelt overførte sygdomme, virale
- Seksuelt overførte sygdomme
- Lentivirus infektioner
- Retroviridae infektioner
- Immunologiske mangelsyndromer
- Langsomme virussygdomme
- HIV-infektioner
- Erhvervet immundefektsyndrom
Andre undersøgelses-id-numre
- IRB00141138
- U01AI134591 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
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 .