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Utvidelsesstudie av sotatercept hos personer med pulmonal hypertensjon (MK-7962-023) (HARMONIZE)

20. juli 2026 oppdatert av: Merck Sharp & Dohme LLC

En fase 2, multisenter, dobbeltblind, utvidelsesstudie for å evaluere effekten av sotatercept for behandling av kombinert postkapillær og precapillary pulmonal hypertensjon (CPC-PH) på grunn av hjertesvikt med bevart utkastingsfraksjon (HFPEF)

Forskere leter etter nye måter å behandle mennesker med en type lungehypertensjon kalt kombinert postkapillær og precapillary pulmonal hypertensjon (CPC-PH). Denne studien fokuserer på CPC-PH som er forårsaket av hjertesvikt med bevart utkastingsfraksjon (HFPEF).

Forskere vil vite om studiebehandlingen, Sotatercept, kan behandle personer med CPC-PH forårsaket av HFPEF. Dette er en utvidelsesstudie, som betyr at personer som deltok i en viss studie om Sotatercept for CPC-PH (kalt en foreldres studie) kan være i stand til å delta i denne studien. I denne utvidelsesstudien vil folk ta sotatercept og forskere vil følge helsen deres i lengre tid.

Hovedmålet med denne utvidelsesstudien er å lære om den langsiktige sikkerheten til Sotatercept og om folk tåler det over lengre tid.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

440

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Belgia
    • Bruxelles-Capitale, Region de
      • Brussels, Bruxelles-Capitale, Region de, Belgia, 1070
        • Université Libre de Bruxelles - Hôpital Erasme ( Site 0100)
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton Health Sciences Hamilton General Hospital ( Site 0004)
  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater, 85032
        • Pulmonary Associates, PA ( Site 1008)
    • California
      • La Jolla, California, Forente stater, 92037
        • Scripps Clinic John R Anderson V Medical Pavillion ( Site 1004)
      • Santa Barbara, California, Forente stater, 93105
        • Jeffrey S. Sager, MD Medical Corporation ( Site 1060)
      • Stanford, California, Forente stater, 94305
        • Stanford University Medical Center ( Site 1024)
    • Colorado
      • Littleton, Colorado, Forente stater, 80120
        • South Denver Cardiology Associates ( Site 1091)
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06520
        • Yale New Haven Hospital ( Site 1093)
    • Florida
      • Orlando, Florida, Forente stater, 32803
        • AdventHealth Orlando ( Site 1058)
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • The Emory Clinic ( Site 1030)
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40202
        • Norton Pulmonary Specialists ( Site 1066)
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68198
        • University Of Nebraska Medical Center ( Site 1053)
    • New York
      • New York, New York, Forente stater, 10065
        • Weill Cornell Medical Center ( Site 1046)
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710-4000
        • Duke University Medical Center ( Site 1026)
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45219
        • The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
      • Cleveland, Ohio, Forente stater, 44195
        • The Cleveland Clinic Foundation. ( Site 1065)
      • Columbus, Ohio, Forente stater, 43210
        • The Ohio State University Wexner Medical Center ( Site 1032)
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15212-4737
        • Allegheny General Hospital ( Site 1088)
      • Wynnewood, Pennsylvania, Forente stater, 19096
        • Lankenau Medical Center ( Site 1089)
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02903
        • Rhode Island Hospital ( Site 1039)
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Medical University of South Carolina ( Site 1003)
    • Tennessee
      • Knoxville, Tennessee, Forente stater, 37919
        • Statcare Pulmonary Consultants ( Site 1031)
    • Utah
      • Murray, Utah, Forente stater, 84107
        • Intermountain Medical Center ( Site 1079)
    • Virginia
      • Falls Church, Virginia, Forente stater, 22042
        • Inova Fairfax Medical Campus ( Site 1078)
      • Richmond, Virginia, Forente stater, 23230
        • Pulmonary Associates of Richmond - West Broad Street ( Site 1069)
  • Frankrike
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, Frankrike, 06000
        • Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 0206)
    • Herault
      • Montpellier, Herault, Frankrike, 34295
        • Hopital Arnaud de Villeneuve ( Site 0200)
    • Loire-Atlantique
      • Saint-Herblain, Loire-Atlantique, Frankrike, 44800
        • Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes ( Site 0205)
    • Maine-et-Loire
      • Angers, Maine-et-Loire, Frankrike, 49100
        • Centre Hopitalier Universitaire d'Angers ( Site 0204)
    • Seine-Maritime
      • Rouen, Seine-Maritime, Frankrike, 76031
        • CHU de Rouen ( Site 0203)
    • Val-de-Marne
      • Le Kremlin-Bicêtre, Val-de-Marne, Frankrike, 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)
  • Italia
      • Pavia, Italia, 27100
        • Fondazione IRCCS Policlinico San Matteo ( Site 0501)
      • Roma, Italia, 00161
        • AOU Policlinico Umberto I ( Site 0500)
    • Lombardy
      • Bergamo, Lombardy, Italia, 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)
  • Spania
      • Barcelona, Spania, 08036
        • Hospital Clinic I Provincial de Barcelona ( Site 0701)
      • Madrid, Spania, 28041
        • Hospital Universitario 12 de Octubre ( Site 0702)
      • Seville, Spania, 41009
        • Hospital Universitario Virgen Macarena ( Site 0705)
      • Toledo, Spania, 45007
        • HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 0703)
    • Malaga
      • Marbella, Malaga, Spania, 29603
        • Hospital Costa del Sol ( Site 0704)
  • Storbritannia
    • London, City of
      • London, London, City of, Storbritannia, W12 OHS
        • Hammersmith Hospital-Department of Cardiology ( Site 0900)
  • 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)

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inkluderingskriterier:

De viktigste inkluderingskriteriene inkluderer, men er ikke begrenset til følgende:

-Fullført MK-7962-007 (kadens) (besøk 9 og slutten av behandlingen [EOT] besøk) uten å avbryte studieinngrep og er i stand til å trygt melde seg på MK-7962-007 (harmonisere)

Eksklusjonskriterier:

De viktigste eksklusjonskriteriene inkluderer, men er ikke begrenset til følgende:

  • Har en diagnose av lungehypertensjon (PH) i Verdens helseorganisasjon (WHO) gruppe 1, WHO Group 3, WHO Group 4, eller WHO Group 5
  • Har hatt en avbrudd i studien
  • Er gravid eller amming
  • Har kronisk leversykdom med alvorlig svekkelse av lever og/eller skrumplever (f.eks. Lever encefalopati) lever)
  • Forventning om mer enn 1 ventilutskiftning eller reparasjon (mekanisk eller biomekanisk) og/eller har gjennomgått mer enn 1 ventilutskifting eller reparasjon
  • Har alvorlig tricuspid -oppstøt på grunn av primær valvulær sykdom (f.eks. Fra endokarditt, karsinoid eller mekanisk ødeleggelse)
  • Forventet eller gjennomgått hjertetransplantasjon eller ventrikkelhjelpsenhet implantasjon
  • Har hatt tidligere eksponering for Luspatercept

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: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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 injeksjon
Andre navn:
  • ACE-011
Eksperimentell: 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 injeksjon
Andre navn:
  • ACE-011

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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

Sponsor

Merck Sharp & Dohme LLC

Etterforskere

  • Studieleder: Medical Director, Merck Sharp & Dohme LLC

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

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)

16. april 2025

Primær fullføring (Antatt)

10. august 2035

Studiet fullført (Antatt)

10. august 2035

Datoer for studieregistrering

Først innsendt

3. februar 2025

Først innsendt som oppfylte QC-kriteriene

3. februar 2025

Først lagt ut (Faktiske)

7. februar 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

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. .

Abonnere