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SOTERIA

Une étude de suivi à long terme ouverte pour évaluer les effets du sotatercept ajouté au traitement de fond de l'hypertension artérielle pulmonaire (pah) pour le traitement de la pah
Source : traduction non-officielle opérée par intelligence artificielle
voir le texte original

An Open-Label Long-Term Follow-Up Study to Evaluate the Effects of Sotatercept when Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH

Soteria
open label sotatercept
Source : Importé depuis le centre
Recrutement ouvert
Dernière modification : 2025/03/17
Type de recherche

Interventionnel

Médicament expérimental

Phase III


Population cible

Condition médicale (spécialité visée)

Donnée non disponible

Profil des participants

Sexe(s) des participants

Hommes

Femmes

Aptitude des participants

Majeurs aptes

Critères de sélection

Critères d'inclusion

1. Participants must have completed their current respective PAH sotatercept clinical study,
must have completed the parent study requirements, and must not have discontinued
early.
2. Participants must be willing to adhere to the study visit schedule and understand and
comply with all protocol requirements.
3. Participants must have the ability to understand and provide written informed consent.
4. Females of childbearing potential (defined in Appendix 3) must:
a. Have a negative pregnancy tests as verified by the investigator prior to starting study
drug administration; she must agree to ongoing pregnancy testing during the course of
the study and until 8 weeks after the last dose of the study drug.
b. If sexually active, have used, and agree to continue to use highly effective
contraception without interruption, for at least 28 days prior to starting the
investigational product, during the study (including dose interruptions), and for
16 weeks (112 days) after discontinuation of study drug.
c. Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration
of the study and for at least 16 weeks (112 days) after the last dose of study drug.
5. Male participants must:
a. Agree to use a condom, defined as a male latex condom or non-latex condom NOT
made out of natural (animal) membrane (e.g., polyurethane), during sexual contact
with a pregnant female or a female of childbearing potential while participating in the
study, during dose interruptions, and for at least 16 weeks (112 days) following
investigational product discontinuation, even if he has undergone a successful
vasectomy (see Appendix 3 for additional contraceptive information).
b. Refrain from donating blood or sperm for the duration of the study and for 16 weeks
(112 days) after the last dose of study drug.
6. Participants must agree not to participate in any other trials of investigational
drugs/devices while they are enrolled in the A011-12 study.

Source : Importé depuis le centre
Critères d'exclusion

1. Not enrolled in a PAH parent study at the time of enrollment.
2. Missed more than the equivalent of 4 consecutive doses between the end of parent study
and the start of this study.
3. Presence of an ongoing serious adverse event (SAE) that occurred during a PAH
sotatercept clinical study that is assessed to be possibly or probably related to sotatercept.
4. Pregnant or breastfeeding females.

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Donnée non disponible
Cohortes
Donnée non disponible
Données à jour depuis : 17 mars 2025

Description de l'étude

Donnée non disponible

Sites

Centres participants

    1 centres
  • CENTRE INTÉGRÉ UNIVERSITAIRE DE SANTÉ ET DE SERVICES SOCIAUX DU CENTRE-OUEST-DE-L’ÎLE-DE-MONTRÉAL * **

    Montréal

    QUÉBEC, CANADA

    Recrutement local
    État du recrutement: OUVERT
    Coordonnées pour le recrutement
    Contacts locaux
    chercheurs:
    • D. Langleben

    co-chercheurs:
    • A. Hirsch

    • N. Messas

    cliquez ici pour plus d'informations pour ce centre
    Cohortes
    Centre intégré universitaire de santé et de services sociaux du Centre-Ouest-de-l’Île-de-Montréal
    Donnée non disponible
    Données à jour depuis : 17 mars 2025

Dernière modification : 17 mars 2025
Données à jour depuis : 17 mars
Origine des données : Nagano
Référence Nagano: 2023-3270