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Et forsøg for at vurdere effektivitet og sikkerhed af octreotid subkutan depot hos patienter med akromegali (ACROINNOVA 1)

29. juli 2026 opdateret af: Camurus AB

Et fase 3, randomiseret, dobbeltblindt, placebokontrolleret, multicenterforsøg for at vurdere effektivitet og sikkerhed af octreotid subkutant depot (CAM2029) hos patienter med akromegali

Formålet med dette forsøg er at vurdere effektiviteten og sikkerheden af ​​CAM2029 hos patienter med akromegali. Patienterne vil blive randomiseret til enten CAM2029 eller placebo administreret subkutant én gang om måneden i løbet af 6 måneder.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

72

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Det Forenede Kongerige
      • Birmingham, Det Forenede Kongerige, B15 2TT
        • College of Medical and Dental Sciences
      • Coventry, Det Forenede Kongerige, CV2 2DX
        • University Hospitals Coventry and Warwickshire NHS Trust
      • Leeds, Det Forenede Kongerige, LS97TF
        • Leeds Teaching Hospitals NHS Trust
      • Manchester, Det Forenede Kongerige, M20 4BX
        • The Christie NHS Foundation Trust
      • Salford, Det Forenede Kongerige, M6 8HD
        • Salford Royal Foundation Trust
  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90095
        • UCLA Department of Medicine Division of Endocrinology
      • Palo Alto, California, Forenede Stater, 94305
        • Stanford University Medical Center
    • Florida
      • Miami, Florida, Forenede Stater, 33130
        • Prufen Clinical Research LLC
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48106
        • University of Michigan
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63110
        • Washington University in St. Louis, School of Medicine
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89148
        • Palm Research Center
    • New York
      • New York, New York, Forenede Stater, 10018
        • Columbia University Medical center
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45267
        • University of Cincinnati
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, Forenede Stater, 15212
        • Allegheny Endocrinology Associates
    • Texas
      • Dallas, Texas, Forenede Stater, 75231
        • Research Institute Of Dallas
  • Grækenland
      • Athens, Grækenland, 115 27
        • General Hospital of Athens "Laiko", Endocrinology University Clinic
      • Athens, Grækenland, 115 28
        • Aretaeio University Hospital Endocrinology Department, Faculty of Diabetes and Metabolism
      • Thessaloniki, Grækenland, 546 42
        • General Hospital of Thessaloniki "Ippokratio"
  • Italien
      • Genova, Italien, 16132
        • IRCCS Policlinico San Martino
      • Naples, Italien, 80131
        • Azienda Universitaria "Federico II"
      • Padova, Italien, 35128
        • Azienda Ospedaliera Padova, Department of Internal medicine
      • Roma, Italien
        • Policlinic Gemelli University Hospital IRCCS, Department of Endocrinology
      • Verona, Italien, 37134
        • AOUI Verona, Policlinic of GB Rossi
  • Polen
      • Krakow, Polen, 30-688
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
      • Krakow, Polen, 31-011
        • Centrum Nowoczesnych Terapii "Dobry Lekarz"
      • Lodz, Polen, 90-644
        • AmiCare Sp. z o.o. Sp. k.
      • Piekary Śląskie, Polen, 41-940
        • Piekarskie Centrum Medyczne, Szpital Miejski
  • Rusland
      • Kazan', Rusland, 420087
        • Interregional Clinical Diagnostic Center
      • Moscow, Rusland
        • "Atlas" Medical Center
      • Moscow, Rusland
        • Sechenov Moscow First State Medical University
      • Moscow, Rusland
        • Vladimirsky Moscow Regional Research Clinical Institute
      • Novosibirsk, Rusland, 630087
        • Novosibirsk State Regional Clinical Hospital
      • Ryazan, Rusland, 420087
        • Interregional Clinical Diagnostic Center
      • Saratov, Rusland, 410053
        • Saratov Regional Clinic Hospital
  • Spanien
      • A Coruña, Spanien, 15006 A
        • University Hospital Complex A Coruña
      • Alicante, Spanien, 03010
        • University Hospital of Alicante
      • Barcelona, Spanien, 08035
        • Hospital Universitario Vall d'Hebron
      • Madrid, Spanien, 28006
        • Hospital Universitario La Princesa
      • Madrid, Spanien, 28009
        • Hospital Universitario Gregorio Marañón
      • Santiago de Compostela, Spanien, 15706
        • Complejo Hospitalario Universitario Santiago de Compostela
      • Seville, Spanien, 41013
        • University Hospital Virgen del Rocio
      • Valencia, Spanien, 46026
        • Hospital Universitario Y Politecnico La Fe
      • Valencia, Spanien, 46600
        • Hospital Universitario de La Ribera
  • Tyrkiet (Türkiye)
      • Antalya, Tyrkiet (Türkiye), 07985
        • Akdeniz University Faculty of Medicine Department of Endocrinology
      • Aydin, Tyrkiet (Türkiye), 09010
        • Aydın Adnan Menderes University Research and Application Hospital
      • Denizli, Tyrkiet (Türkiye), 20070
        • Pamukkale University Faculty of Medicine Department of Endocrinology
      • Eskişehir, Tyrkiet (Türkiye), 26480
        • Eskisehir Osmangazi University Medical Faculty
      • Fatih, Tyrkiet (Türkiye), 34098
        • Istanbul University Medical Faculty
      • Kocaeli, Tyrkiet (Türkiye), 41000
        • Kocaeli University Faculty of Medicine Department of Endocrinology and Metabolism
      • Malatya, Tyrkiet (Türkiye), 44000
        • Inonu University Medical Faculty Endocrinology Department
      • Melikgazi, Tyrkiet (Türkiye), 38039
        • Erciyes University Medical Faculty, Dept. of Endocrinology
      • Trabzon, Tyrkiet (Türkiye), 61080
        • Karadeniz Technical University Farabi Hospital
      • Zonguldak, Tyrkiet (Türkiye), 67600
        • Zonguldak Bulent Ecevit University Department of Internal Medicine, Division of Endocrinology and Metabolism Ibni Sina Campus
  • Tyskland
      • Essen, Tyskland, 45147
        • Universitatsklinikum Essen
      • Frankfurt, Tyskland, 60590
        • Universitätsklinikum Frankfurt, Medizinische Klinik 1, Schwerpunkt Endokrinologie, Diabetologie, Ernährungsmedizin
      • Freiburg im Breisgau, Tyskland, 79601
        • Universitätsklinikum Freiburg
      • Munich, Tyskland, 80336
        • LMU Clinic of University of Munich, Medical Clinic and Polyclinic IV
      • Munich, Tyskland, 81667
        • Medicover Neuroendokrinologie
      • Oldenburg, Tyskland, 26122
        • Medicover Oldenburg MVZ
  • Ungarn
      • Budapest, Ungarn, 1062
        • Military Healt Center, 2nd Department of Internal Medicine
      • Szeged, Ungarn, 6720
        • SZTE ÁOK I.sz. Belgyógyászati Klinika

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Mandlige eller kvindelige patienter, ≥18 år ved screening
  • Kunne give skriftligt informeret samtykke til at deltage i forsøget, før der udføres forsøgsrelaterede procedurer
  • Diagnose af akromegali ved historisk bevis for (vedvarende eller tilbagevendende) akromegali
  • Behandling med en stabil dosis af octreotid LAR eller lanreotid ATG i mindst 3 måneder som monoterapi før screening
  • IGF-1-niveauer ≤1xULN ved screening
  • Tilstrækkelig lever-, bugspytkirtel-, nyre- og knoglemarvsfunktion
  • Normalt EKG

Ekskluderingskriterier:

  • GH ≥2,5 μg/L ved screening (cyklus)
  • Har modtaget medicinsk behandling for akromegali med pasireotid (inden for 6 måneder før screening), pegvisomant (inden for 3 måneder før screening), dopaminagonister (inden for 3 måneder før screening) eller andre forsøgsmidler (inden for 30 dage eller 5 halveringstider før screening [alt efter hvad der er længst]
  • Patienter, der normalt tager octreotid LAR eller lanreotid ATG sjældnere end hver 4. uge (f. hver 6. uge eller 8. uge)
  • Patienter med kompression af den optiske chiasme, der forårsager enhver synsfeltdefekt, for hvem kirurgisk indgreb er indiceret
  • Patienter, der har gennemgået større operationer/kirurgisk behandling af en hvilken som helst årsag inden for 1 måned fra screening
  • Patienter, der har gennemgået en hypofyseoperation inden for 6 måneder før screening
  • Patienter, der tidligere har modtaget hypofysebestråling
  • Patienter med dårligt kontrolleret diabetes mellitus (hæmoglobin A1c >8,0 %)

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CAM2029 (octreotid subkutant depot)
CAM2029 (octreotid subkutant depot) 20mg/1,0 ml til 20 mg dosis, subkutan injektion én gang om måneden, seks måneders behandling. Hvis nedtitrering er påkrævet, er 10 mg/0,5 ml til 10 mg dosis tilgængelig.
Medicin: CAM2029 (octreotid subkutant depot)
Octreotid subkutant depot til månedlige injektioner hos akromegalipatienter
Andre navne:
  • CAM2029
Placebo komparator: Matchende placebo
Placebo (subkutant depot) 1,0 ml, subkutan injektion én gang om måneden, seks måneders behandling. Hvis nedtitrering er påkrævet, er 0,5 ml dosis tilgængelig.
Medicin: Matchende placebo
Matchende placebo til CAM2029
Andre navne:
  • placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Participants With Mean Insulin-like Growth Factor -1 (IGF-1) Levels ≤1 x Upper Limit of Normal (ULN) at Week 22/24
Tidsramme: Week 22 and 24
If one of the IGF-1 values at Week 22 or Week 24 was missing, the other value was used to define a responder/non-responder in the analysis. The variable of interest was considered missing only if no IGF-1 value could be obtained from either the Week 22 or the Week 24 sample. A composite strategy was assumed for intercurrent events, and a participant was considered as a non-responder if they discontinued IMP, or had the dose reduced prior to Week 22 (regardless of IGF-1 values), and/or was switched to rescue medication. ULN was derived from the participant's sex and age at screening. In order to account for all participants in the intention-to-treat (ITT) analysis set, multiple imputation was applied. The mean proportion of responders was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants".
Week 22 and 24

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Participants With Mean IGF-1 Levels ≤1x Upper Limit or Normal (ULN) at Week 22/24, Including Participants With Dose Reduction
Tidsramme: Week 22 and 24
First key secondary endpoint. If one of the IGF-1 values at Week 22 or Week 24 was missing, the other value was used to define a responder/non-responder in the analysis. The variable of interest was considered missing only if no IGF-1 value could be obtained from either the Week 22 or the Week 24 sample. A composite strategy was assumed for intercurrent events, and a participant was considered as a non-responder if they discontinued IMP and/or was switched to rescue medication. For this endpoint, a patient who had their dose reduced was not directly classified as a non-responder. No participant had their dose reduced during the trial. ULN was derived from the participant's sex and age at screening. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of responders was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants"
Week 22 and 24
Proportion of Participants With Mean IGF-1 Levels ≤1xULN at Week 22/Week 24 and Mean Growth Hormone (GH) Levels <2.5 µg/L at Week 24
Tidsramme: Week 22 and 24
Second key secondary endpoint. If one of the IGF-1 values at Week 22 or Week 24 was missing, the other value was used to define a responder/non-responder in the analysis. The variable of interest was considered missing only if no IGF-1 value could be obtained from either the Week 22 or the Week 24 sample or no GH value at Week 24. A composite strategy was assumed for intercurrent events, and a patient was considered as a non-responder if they discontinued IMP or had the dose reduced prior to Week 22 (regardless of IGF-1 values), and/or was switched to rescue medication. ULN was based on the patient's sex and age at screening. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of responders was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants".
Week 22 and 24
Proportion of Participants With Mean GH Levels <2.5 µg/L at Week 24
Tidsramme: Week 24
For the responder analysis of mean GH <2.5 µg/L at Week 24, a composite strategy was assumed for intercurrent events. A participant was considered as a non-responder if they discontinued IMP, or had the dose reduced prior to Week 24 (regardless of mean GH values), and/or was switched to rescue medication. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of participants was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants".
Week 24
Proportion of Participants With Mean GH Levels <1.0 µg/L at Week 24
Tidsramme: Week 24
For the responder analysis of mean GH <1.0 µg/L at Week 24, a composite strategy was assumed for intercurrent events. A participant was considered as a non-responder if they discontinued IMP, or had the dose reduced prior to Week 24 (regardless of mean GH values), and/or was switched to rescue medication. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of participants was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants".
Week 24
Number of Participants With Treatment Emergent Adverse Events
Tidsramme: Week 0 to 24
A treatment emergent adverse event was defined as an adverse event that occurred during or after the first administration of the IMP to the end of trial visit or the next dose of any acromegaly treatment, whichever came first.
Week 0 to 24
Proportion of Participants/Partners Declared Competent by a Healthcare Professional to Administer Intervention
Tidsramme: Week 0 to 20 and Week 24
During participants'/partners' first three attempts during the trial period of 24 weeks whenever these visits took place. Percentages were based on those who opted for self-/partner-administration.
Week 0 to 20 and Week 24
Octreotide Plasma Concentrations Over Time
Tidsramme: Week 0 to 24
Plasma samples were taken pre-dose on dosing days.
Week 0 to 24

Samarbejdspartnere og efterforskere

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

Sponsor

Camurus AB

Efterforskere

  • Ledende efterforsker: Pamela Freda, M.D, Columbia 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

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. august 2019

Primær færdiggørelse (Faktiske)

2. maj 2023

Studieafslutning (Faktiske)

2. maj 2023

Datoer for studieregistrering

Først indsendt

29. august 2019

Først indsendt, der opfyldte QC-kriterier

30. august 2019

Først opslået (Faktiske)

3. september 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HS-18-633
  • 2019-001191-11 (EudraCT nummer)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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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