A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

Официальное название

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 (MK-7962-038)

Обзор

Researchers are looking for more ways to treat PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow. This causes high blood pressure in the lungs and overworks the heart. PAH can make it hard to breathe and be active. Some standard (usual) treatments for PAH can treat symptoms of PAH but do not stop PAH from getting worse. Sotatercept is a study medicine designed to treat PAH. It is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH. This is a long-term follow-up (LTFU) study. People who took part in certain other studies testing sotatercept for PAH may be able to join this study. The goal of this study is to learn about the long-term safety of sotatercept and if people tolerate it when taken with standard PAH treatment over a longer period of time.

Подробное описание

LTFU PAH sotatercept study MK-7962-004 (Obsolete Identifier: NCT04796337) has been incorporated into the current MK-7962-038 (NCT07218029) study for administrative reasons. The MK-7962-004 study is no longer enrolling participants and will be formally closed. Only those who participated in MK-7962-004 may be eligible to continue into MK-7962-038.

Вмешательства

• Биопрепарат Sotatercept
  Sotatercept SC injection every 3 weeks

Первичные конечные точки

• Number of Participants Who Experience an Adverse Event (AE) [Срок оценки: Up to approximately 90 months]
• Number of Participants Who Discontinue Study Treatment Due to an AE [Срок оценки: Up to approximately 86 months]
• Number of Participants with Detectable Anti-Drug Antibodies (ADAs) [Срок оценки: Up to approximately 88 months]
• Laboratory parameters (Hematology): Concentration of Platelets and Hemoglobin [Срок оценки: Up to approximately 88 months]
• Laboratory parameters (Chemistry): Concentration of Creatinine, Total Bilirubin, and Alanine Aminotransferase (ALT) [Срок оценки: Up to approximately 86 months]
• Change From Baseline in Body Weight [Срок оценки: Baseline and up to approximately 86 months]
• Change From Baseline in Blood Pressure [Срок оценки: Baseline and up to approximately 86 months]
• Change From Baseline in Electrocardiogram (ECG) [Срок оценки: Baseline and up to approximately 86 months]

Вторичные конечные точки (5)

• Change From Baseline in 6-Minute Walk Distance (6MWD) [Срок оценки: Baseline and up to approximately 48 months]
• Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels [Срок оценки: Baseline and up to approximately 48 months]
• Change From Baseline in the Percentage of Participants Who Improve or Show Maintenance in Modified New York Heart Association/ World Health Organization Classification of Functional Status (WHO FC) [Срок оценки: Baseline and up to approximately 48 months]
• Change From Baseline in Pulmonary Vascular Resistance (PVR) [Срок оценки: Baseline and up to approximately 48 months]
• Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator [Срок оценки: Baseline and up to approximately 48 months]

Критерии участия

Критерии включения

The main inclusion criteria include but are not limited to the following:

• Has completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early
• Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements
• Must have the ability to understand and provide documented informed consent

Критерии исключения

The main exclusion criteria include but are not limited to the following:

• Did not participate in a sotatercept PAH parent study
• Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.
• Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept
• Is a female who is pregnant or breastfeeding
• Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study
• Is currently enrolled in another investigational product study other than a sotatercept study
• Is incapacitated

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 35 центров

• Pulmonary Associates, PA ( Site 1008) — Phoenix
• Arizona Pulmonary Specialists ( Site 1010) — Scottsdale
• University of Arizona ( Site 1006) — Tucson
• University of California San Diego Health ( Site 1002) — La Jolla
• UC Irvine Health Medical Center ( Site 1086) — Orange
• UC Davis - Medial Center ( Site 1064) — Sacramento
• UCSF Helen Diller Medical Center at Parnassus Heights ( Site 1019) — San Francisco
• Jeffrey S. Sager, MD Medical Corporation ( Site 1060) — Santa Barbara
• … и ещё 27 центров

Франция · 13 центров

• Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311) — Nice
• CHU Bordeaux Haut-Leveque ( Site 1312) — Pessac
• Nouvel Hôpital Civil (NHC) ( Site 1307) — Strasbourg
• Hopital Cavale Blanche ( Site 1314) — Brest
• Hopital Larrey ( Site 1315) — Toulouse
• CHU de Grenoble Hopital Nord ( Site 1303) — La Tronche
• Hopital Nord Laennec ( Site 1309) — Saint-Herblain
• CHU Angers ( Site 1313) — Angers
• … и ещё 5 центров

Германия · 10 центров

• Thoraxklinik-Heidelberg gGmbH ( Site 1509) — Heidelberg
• Krankenhaus Neuwittelsbach ( Site 1510) — München
• Universitaetsklinik Regensburg ( Site 1503) — Regensburg
• UKGM Gießen/Marburg ( Site 1512) — Giessen
• Medizinische Hochschule Hannover ( Site 1505) — Hanover
• … и ещё 5 центров

Испания · 9 центров

Список центров уточняется — проверьте первичный протокол.

Аргентина · 7 центров

• Instituto de Investigaciones Clinicas Quilmes ( Site 1903) — Quilmes
• Instituto Médico Río Cuarto ( Site 1907) — Río Cuarto
• Sanatorio Parque ( Site 1905) — Rosario
• Instituto Cardiovascular de Rosario ( Site 1906) — Rosario
• Hospital Provincial del Centenario ( Site 1912) — Rosario
• Sanatorio Allende ( Site 1908) — Córdoba
• Hospital Provincial Dr. Jose M. Cullen ( Site 1902) — Santa Fe

Великобритания · 7 центров

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Австралия · 6 центров

• Royal Prince Alfred Hospital ( Site 1106) — Camperdown
• The Prince Charles Hospital ( Site 1104) — Chermside
• John Hunter Hospital ( Site 1101) — New Lambton Heights
• Royal Adelaide Hospital ( Site 1109) — Adelaide
• Royal Hobart Hospital ( Site 1107) — Hobart
• Fiona Stanley Hospital ( Site 1103) — Murdoch

Израиль · 4 центра

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Италия · 4 центра

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Бразилия · 3 центра

• Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 1805) — Porto Alegre
• Hospital Dia do Pulmao ( Site 1802) — Blumenau
• Instituto do Coracao - HCFMUSP ( Site 1803) — São Paulo

Греция · 3 центра

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Сербия · 3 центра

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South Korea · 3 центра

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Бельгия · 2 центра

• Université Libre de Bruxelles - Hôpital Erasme ( Site 1402) — Brussels
• UZ Leuven ( Site 1401) — Leuven

Канада · 2 центра

• Peter Lougheed Centre ( Site 2102) — Calgary
• University of Alberta Hospital ( Site 2101) — Edmonton

Колумбия · 2 центра

• Fundación Neumológica Colombiana ( Site 3403) — Bogotá
• Clínica Imbanaco S.A.S ( Site 3404) — Cali

Чехия · 2 центра

• Institut Klinicke a Experimentalni Mediciny ( Site 2202) — Prague
• Vseobecna fakultni nemocnice v Praze ( Site 2201) — Prague

Дания · 2 центра

• Rigshospitalet ( Site 3802) — København Ø
• Aarhus Universitetshospital, Skejby ( Site 3801) — Aarhus

Нидерланды · 2 центра

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Польша · 2 центра

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Португалия · 2 центра

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Тайвань · 2 центра

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Хорватия · 1 центр

• Klinicki Bolnicki Centar Split ( Site 3901) — Split

Новая Зеландия · 1 центр

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Швеция · 1 центр

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Швейцария · 1 центр

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Публикации

• Preston IR, Badesch D, Ghofrani HA, Gibbs JSR, Gomberg-Maitland M, Hoeper MM, Humbert M, McLaughlin VV, Waxman AB, Manimaran S, Mikhailova E, Reddy M, Lau A, de Oliveira Pena J, Souza R. A long-term follow-up study of sotatercept for treatment of pulmonary arterial hypertension: interim results of SOTERIA. Eur Respir J. 2025 Jul 24;66(1):2401435. doi: 10.1183/13993003.01435-2024. Print 2025 Jul. PMID 39978862

Идентификаторы

NCT: NCT07218029 · 7962-038 · 2025-521970-33-00 · U1111-1321-4943 · MK-7962-038 · MK-7962-004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗