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Udvidelsesundersøgelse af sotatercept hos mennesker med pulmonal hypertension (MK-7962-023) (HARMONIZE)

20. juli 2026 opdateret af: Merck Sharp & Dohme LLC

En fase 2, multicenter, dobbeltblind, udvidelsesundersøgelse for at evaluere virkningerne af Sotatercept til behandling af kombineret postkapillær og forudgående pulmonal hypertension (CPC-Ph) på grund af hjertesvigt med konserveret ejektionsfraktion (HFPEF)

Forskere er på udkig efter nye måder at behandle mennesker med en type pulmonal hypertension kaldet kombineret postkapillær og forudgående pulmonal hypertension (CPC-Ph). Denne undersøgelse fokuserer på CPC-Ph, der er forårsaget af hjertesvigt med konserveret ejektionsfraktion (HFPEF).

Forskere vil vide, om undersøgelsesbehandlingen, Sotatercept, kan behandle mennesker med CPC-Ph forårsaget af HFPEF. Dette er en udvidelsesundersøgelse, som betyder, at folk, der deltog i en bestemt undersøgelse af Sotatercept for CPC-Ph (kaldet en forældrestudie), kan muligvis deltage i denne undersøgelse. I denne udvidelsesundersøgelse vil folk tage Sotatercept, og forskere vil følge deres helbred i længere tid.

Hovedmålet med denne udvidelsesundersøgelse er at lære om den langsigtede sikkerhed for Sotatercept, og hvis folk tolererer det over en længere periode.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is an extension study for studies MK-7962-007 (NCT04945460) and MK-7962-041 (NCT number pending).

Following protocol amendment 3, all participants in the Sotatercept 0.7 mg/kg arm will switch to the Sotatercept 0.3 mg/kg arm, and new participants will only enroll in the Sotatercept 0.3 mg/kg arm.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

440

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Belgien
    • Bruxelles-Capitale, Region de
      • Brussels, Bruxelles-Capitale, Region de, Belgien, 1070
        • Université Libre de Bruxelles - Hôpital Erasme ( Site 0100)
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton Health Sciences Hamilton General Hospital ( Site 0004)
  • Det Forenede Kongerige
    • London, City of
      • London, London, City of, Det Forenede Kongerige, W12 OHS
        • Hammersmith Hospital-Department of Cardiology ( Site 0900)
  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85032
        • Pulmonary Associates, PA ( Site 1008)
    • California
      • La Jolla, California, Forenede Stater, 92037
        • Scripps Clinic John R Anderson V Medical Pavillion ( Site 1004)
      • Santa Barbara, California, Forenede Stater, 93105
        • Jeffrey S. Sager, MD Medical Corporation ( Site 1060)
      • Stanford, California, Forenede Stater, 94305
        • Stanford University Medical Center ( Site 1024)
    • Colorado
      • Littleton, Colorado, Forenede Stater, 80120
        • South Denver Cardiology Associates ( Site 1091)
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06520
        • Yale New Haven Hospital ( Site 1093)
    • Florida
      • Orlando, Florida, Forenede Stater, 32803
        • AdventHealth Orlando ( Site 1058)
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • The Emory Clinic ( Site 1030)
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
        • Norton Pulmonary Specialists ( Site 1066)
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68198
        • University Of Nebraska Medical Center ( Site 1053)
    • New York
      • New York, New York, Forenede Stater, 10065
        • Weill Cornell Medical Center ( Site 1046)
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710-4000
        • Duke University Medical Center ( Site 1026)
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
        • The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
      • Cleveland, Ohio, Forenede Stater, 44195
        • The Cleveland Clinic Foundation. ( Site 1065)
      • Columbus, Ohio, Forenede Stater, 43210
        • The Ohio State University Wexner Medical Center ( Site 1032)
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15212-4737
        • Allegheny General Hospital ( Site 1088)
      • Wynnewood, Pennsylvania, Forenede Stater, 19096
        • Lankenau Medical Center ( Site 1089)
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02903
        • Rhode Island Hospital ( Site 1039)
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Medical University of South Carolina ( Site 1003)
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37919
        • Statcare Pulmonary Consultants ( Site 1031)
    • Utah
      • Murray, Utah, Forenede Stater, 84107
        • Intermountain Medical Center ( Site 1079)
    • Virginia
      • Falls Church, Virginia, Forenede Stater, 22042
        • Inova Fairfax Medical Campus ( Site 1078)
      • Richmond, Virginia, Forenede Stater, 23230
        • Pulmonary Associates of Richmond - West Broad Street ( Site 1069)
  • Frankrig
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, Frankrig, 06000
        • Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 0206)
    • Herault
      • Montpellier, Herault, Frankrig, 34295
        • Hopital Arnaud de Villeneuve ( Site 0200)
    • Loire-Atlantique
      • Saint-Herblain, Loire-Atlantique, Frankrig, 44800
        • Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes ( Site 0205)
    • Maine-et-Loire
      • Angers, Maine-et-Loire, Frankrig, 49100
        • Centre Hopitalier Universitaire d'Angers ( Site 0204)
    • Seine-Maritime
      • Rouen, Seine-Maritime, Frankrig, 76031
        • CHU de Rouen ( Site 0203)
    • Val-de-Marne
      • Le Kremlin-Bicêtre, Val-de-Marne, Frankrig, 94270
        • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0202)
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus ( Site 0403)
      • Holon, Israel, 5810001
        • Edith Wolfson Medical Center ( Site 0404)
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center ( Site 0402)
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center ( Site 0401)
      • Safed, Israel, 1311001
        • ZIV Medical Center ( Site 0400)
  • Italien
      • Pavia, Italien, 27100
        • Fondazione IRCCS Policlinico San Matteo ( Site 0501)
      • Roma, Italien, 00161
        • AOU Policlinico Umberto I ( Site 0500)
    • Lombardy
      • Bergamo, Lombardy, Italien, 24127
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 0502)
  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64718
        • Unidad de Investigacion Clinica en Medicina, S.C. ( Site 2505)
  • Polen
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Polen, 31-202
        • Krakowski Szpital Specjalistyczny im. Jana Pawła II-Oddzial Kliniczny Chorob Serca i Naczyn z Podod ( Site 0600)
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Polen, 20-718
        • Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego ( Site 0601)
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Polen, 15-276
        • Uniwersytecki Szpital Kliniczny w Bialymstoku ( Site 0603)
  • Spanien
      • Barcelona, Spanien, 08036
        • Hospital Clinic I Provincial de Barcelona ( Site 0701)
      • Madrid, Spanien, 28041
        • Hospital Universitario 12 de Octubre ( Site 0702)
      • Seville, Spanien, 41009
        • Hospital Universitario Virgen Macarena ( Site 0705)
      • Toledo, Spanien, 45007
        • HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 0703)
    • Malaga
      • Marbella, Malaga, Spanien, 29603
        • Hospital Costa del Sol ( Site 0704)
  • Sverige
    • Västra Götaland County
      • Gothenburg, Västra Götaland County, Sverige, 413 46
        • Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 0800)
  • Tyskland
      • Berlin, Tyskland, 14050
        • DRK Kliniken Berlin Westend ( Site 0307)
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Tyskland, 69126
        • Thoraxklinik-Heidelberg gGmbH ( Site 0309)
    • Bavaria
      • München, Bavaria, Tyskland, 80639
        • Krankenhaus Neuwittelsbach ( Site 0310)
    • Hesse
      • Giessen, Hesse, Tyskland, 35392
        • UKGM Gießen/Marburg ( Site 0312)
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Tyskland, 50937
        • Universitaetsklinikum Koeln ( Site 0311)
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Tyskland, 55131
        • Universitätsmedizin Johannes Gutenberg Universität Mainz ( Site 0315)
    • Saxony
      • Dresden, Saxony, Tyskland, 01307
        • Universitaetsklinikum Carl Gustav Carus Dresden ( Site 0301)

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inkluderingskriterier:

De vigtigste inkluderingskriterier inkluderer, men er ikke begrænset til følgende:

-Fuldført MK-7962-007 (Cadence) (besøg 9 og afslutningen af ​​behandlingen [EOT] Besøg) uden at afbryde studieintervention og er i stand til sikkert at tilmelde sig MK-7962-007 (Harmonize)

Ekskluderingskriterier:

De vigtigste udelukkelseskriterier inkluderer, men er ikke begrænset til følgende:

  • Har en diagnose af pulmonal hypertension (PH) i Verdenssundhedsorganisationen (WHO) Gruppe 1, WHO Group 3, WHO Group 4, eller WHO Group 5
  • Har haft en undersøgelse af undersøgelsen af ​​intervention
  • Er gravid eller ammende
  • Har kronisk leversygdom med alvorlig nedsat leverfunktion og/eller cirrhose (f.eks. Hepatisk encephalopati)
  • Forventning om mere end 1 ventiludskiftning eller reparation (mekanisk eller biomekanisk) og/eller har gennemgået mere end 1 ventiludskiftning eller reparation
  • Har alvorlig tricuspid regurgitation på grund af primær valvulær sygdom (f.eks. Fra endocarditis, carcinoid eller mekanisk ødelæggelse)
  • Forventet eller gennemgået hjertetransplantation eller ventrikulær hjælpeindretning implantation
  • Har haft forudgående eksponering for Luspatercept

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sotatercept 0.3 mg/kg
Participants receive sotatercept 0.3 mg/kg subcutaneous (SC) injection every 3 weeks (Q3W) for up to approximately 10 years or until discontinuation.
Biologisk: Sotatercept
subkutan injektion
Andre navne:
  • ACE-011
Eksperimentel: Sotatercept 0.7 mg/kg
Participants receive sotatercept 0.7 mg/kg SC injection Q3W for up to approximately 10 years or until discontinuation.
Biologisk: Sotatercept
subkutan injektion
Andre navne:
  • ACE-011

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Who Experience an Adverse Event (AE)
Tidsramme: Up to approximately 10 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. The number of participants who experience an AE will be reported.
Up to approximately 10 years
Number of Participants Who Discontinue Study Treatment Due to an AE
Tidsramme: Up to approximately 10 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. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 10 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Parent Study Baseline in Pulmonary Vascular Resistance (PVR) at 6 Months Following Enrollment in the Extension
Tidsramme: Baseline and Month 6
PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization (RHC). The change from baseline in PVR at Month 6 will be presented. Per protocol, baseline was defined as the baseline data collected for each participant at the time of their enrollment on one of the parent studies.
Baseline and Month 6
Change From Baseline in the 6-Minute Walk Distance (6MWD) at 6 Months Following Enrollment in the Extension
Tidsramme: Baseline and Month 6
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Month 6 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Baseline and Month 6
Change From Baseline in the 6MWD at 12 Months Following Enrollment in the Extension
Tidsramme: Baseline and Month 12
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Month 12 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Baseline and Month 12
Change From Baseline in the 6MWD at 18 Months Following Enrollment in the Extension
Tidsramme: Baseline and Month 18
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Month 18 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Baseline and Month 18
Change From Baseline in the 6MWD at End of Treatment
Tidsramme: Baseline and up to approximately 43.5 months
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at the time of treatment discontinuation will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Baseline and up to approximately 43.5 months
Change From Baseline in New York Heart Association Functional Class (NYHA FC) at 6 Months Following Enrollment in the Extension
Tidsramme: Baseline and Month 6
NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Month 6 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Baseline and Month 6
Change From Baseline in NYHA FC at 12 Months Following Enrollment in the Extension
Tidsramme: Baseline and Month 12
NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Month 12 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Baseline and Month 12
Change From Baseline in NYHA FC at 18 Months Following Enrollment in the Extension
Tidsramme: Baseline and Month 18
NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Month 18 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Baseline and Month 18
Change From Baseline in NYHA FC at End of Treatment
Tidsramme: Baseline and up to approximately 10 years
NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at the time of treatment discontinuation will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Baseline and up to approximately 10 years
Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) at 6 Months Following Enrollment in the Extension
Tidsramme: Baseline and Month 6
NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. The change from baseline in NT-proBNP at Month 6 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Baseline and Month 6
Change From Baseline in NT-proBNP at 12 Months Following Enrollment in the Extension
Tidsramme: Baseline and Month 12
NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. The change from baseline in NT-proBNP at Month 12 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Baseline and Month 12
Change From Baseline in NT-proBNP at 18 Months Following Enrollment in the Extension
Tidsramme: Baseline and Month 18
NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. The change from baseline in NT-proBNP at Month 18 will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Baseline and Month 18
Change From Baseline in NT-proBNP at End of Treatment
Tidsramme: Baseline and up to approximately 10 years
NT-proBNP is an established marker of ventricular dysfunction in participants with PAH. The change from baseline in NT-proBNP at the time of treatment discontinuation will be presented. Per protocol, baseline may be either parent study baseline or the time of enrollment on this extension.
Baseline and up to approximately 10 years
Change From Parent Study Week 24 in PVR at 6 Months Following Enrollment in the Extension for Placebo Participants
Tidsramme: Baseline and Month 6
PVR, a hemodynamic variable of pulmonary circulation, is measured by right heart catheterization (RHC). The change from parent study Week 24 in PVR at Month 6 will be presented. Per protocol, baseline was defined as the value collected at Week 24 of the parent study.
Baseline and Month 6
Change From Baseline in 6MWD at 6 Months Following Enrollment in the Extension for Placebo Participants
Tidsramme: Baseline and Month 6
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Month 6 will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension.
Baseline and Month 6
Change From Baseline in 6MWD at 12 Months Following Enrollment in the Extension for Placebo Participants
Tidsramme: Baseline and Month 12
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Month 12 will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension.
Baseline and Month 12
Change From Baseline in 6MWD at 18 Months Following Enrollment in the Extension for Placebo Participants
Tidsramme: Baseline and Month 18
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at Month 18 will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension.
Baseline and Month 18
Change From Baseline in 6MWD at End of Treatment for Placebo Participants
Tidsramme: Baseline and up to approximately 43.5 months
The 6MWD tests the distance walked in 6 minutes as a measure of functional capacity. The change from baseline in 6MWD at the time of treatment discontinuation will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension.
Baseline and up to approximately 43.5 months
Change From Baseline in NYHA FC at 6 Months Following Enrollment in the Extension for Placebo Participants
Tidsramme: Baseline and Month 6
NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Month 6 will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension.
Baseline and Month 6
Change From Baseline in NYHA FC at 12 Months Following Enrollment in the Extension for Placebo Participants
Tidsramme: Baseline and Month 12
NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Month 12 will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension.
Baseline and Month 12
Change From Baseline in NYHA FC at 18 Months Following Enrollment in the Extension for Placebo Participants
Tidsramme: Baseline and Month 18
NYHA FC classifies the extent of heart failure. The change from baseline in NYHA FC at Month 18 will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension.
Baseline and Month 18
Change From Baseline in NYHA FC at End of Treatment for Placebo Participants
Tidsramme: Baseline and up to approximately 10 years
NYHA FC classifies the extent of heart failure. The change from extension baseline in NYHA FC at the time of treatment discontinuation will be presented. Per protocol, extension baseline was defined as the time of enrollment in the extension.
Baseline and up to approximately 10 years

Samarbejdspartnere og efterforskere

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

Sponsor

Merck Sharp & Dohme LLC

Efterforskere

  • Studieleder: Medical Director, Merck Sharp & Dohme LLC

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.

Hjælpsomme links

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)

16. april 2025

Primær færdiggørelse (Anslået)

10. august 2035

Studieafslutning (Anslået)

10. august 2035

Datoer for studieregistrering

Først indsendt

3. februar 2025

Først indsendt, der opfyldte QC-kriterier

3. februar 2025

Først opslået (Faktiske)

7. februar 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 7962-023
  • MK-7962-023 (Anden identifikator: MSD)
  • U1111-1309-2142 (Registry Identifier: UTN)
  • 2024-515773-99-00 (Registry Identifier: EU CT)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

http://engagezone.msd.com/doc/procedureAccessClinicaltriethata.pdf

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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