A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

Официальное название

A PHASE 2, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF PF-07868489 ADMINISTERED TO ADULT PARTICIPANTS WITH PULMONARY ARTERIAL HYPERTENSION

Обзор

The purpose of this study is to learn about the long-term safety, tolerability and effects of the study medicine (PF-07868489) for the possible treatment of PAH. PAH is a condition in which there is high blood pressure in the arteries that carry blood from the heart to the lungs. This high pressure makes it harder for the heart to pump blood through those lungs, potentially damaging the right side of the heart. This is an open-label study. Which means that both the healthcare providers and the study participants are aware of the medicine being given. This study is also an extension study with study medicine (PF-07868489). An extension study allows patients from an earlier clinical study (also called as qualifying study) to continue participating to assess long-term benefits and safety of the medicine.

Вмешательства

• Препарат PF-07868489
  Participants will receive subcutaneous doses of PF-07868489 every 4 weeks

Первичные конечные точки

• Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: Baseline up to week 111]
• Number of Participants With Change From Baseline in Laboratory Tests Results [Срок оценки: Baseline up to week 111]
• Number of Participants With Vital Sign Abnormalities [Срок оценки: Baseline up to week 111]

Вторичные конечные точки (4)

• Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters [Срок оценки: Baseline up to week 111]
• Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration [Срок оценки: Baseline up to week 104]
• Minimum Observed Plasma Trough Concentration (Cmin), as data permits [Срок оценки: Baseline up to week 111]
• Incidence of Anti-Drug Antibody (ADA) [Срок оценки: Baseline up to week 111]

Критерии участия

This study is seeking participants who are:

• aged 18 years or older at screening of the previous study and completed the required treatment duration with PF-07868469 and other assessments at the end of that study.
• willing and able to abide with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
• do not have worsening or hospitalization for worsening PAH during the qualifying study.
• not on placement for a surgery to replace any tissue or part of the body (transplant), and planned surgery for PAH.
• do not have an ongoing major health issue in the qualifying study, which in the opinion of the study doctor could make the participant not qualify for this study.
• not suffering from or in the past have suffered from hepato-pulmonary syndrome (liver-related lung problem).
• not currently prescribed or taking medicines called as GLP-1 agonist.

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 · 13 центров

• UC Davis Health Medical Center — Sacramento
• UCSF Health St. Mary's Hospital — San Francisco
• Heart and Vascular Center — San Francisco
• University of Colorado Anschutz Medical Campus — Aurora
• Norton Hospital — Louisville
• Norton Pulmonary Specialists — Louisville
• Mount Sinai Hospital — New York
• Clinical Trials Unit at Eastowne Medical Office Building — Chapel Hill
• … и ещё 5 центров

Германия · 5 центров

• Thoraxklinik-Heidelberg gGmbH — Heidelberg
• Universitätsklinikum Regensburg — Regensburg
• Universitaetsklinikum Giessen und Marburg GmbH — Giessen
• Universitätsmedizin Greifswald — Greifswald
• Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden — Dresden

Китай · 4 центра

• Guangdong Provincial People's Hospital — Гуанчжоу
• The Second Xiangya Hospital of Central South University — Чанша
• Zhongda Hospital Southeast University — Нанкин
• Shanghai Pulmonary Hospital — Шанхай

Япония · 4 центра

• Kobe University Hospital — Kobe
• St. Marianna University Hospital — Kawasaki
• Tohoku University Hospital — Sendai
• National Hospital Organization Okayama Medical Center — Okayama

South Korea · 4 центра

• Gachon University Gil Medical Center — Incheon
• Seoul National University Hospital — Seoul
• Severance Hospital, Yonsei University Health System — Seoul
• Samsung Medical Center — Seoul

Греция · 3 центра

• University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" — Chaïdári
• Onassis Hospital — Kallithea
• AHEPA University General Hospital of Thessaloniki — Thessaloniki

Испания · 3 центра

• Hospital Universitario Marques de Valdecilla — Santander
• Hospital Universitario La Paz — Madrid
• Hospital Universitario 12 de Octubre — Madrid

Австралия · 2 центра

• Royal Prince Alfred Hospital — Camperdown
• Pulmonary Hypertension Research Queensland Pty Ltd — Auchenflower

Бельгия · 2 центра

• HUB Hôpital Erasme — Brussels
• UZ Leuven — Leuven

Канада · 2 центра

• London Health Sciences Centre - University Hospital — London
• London Health Sciences Centre — London

Франция · 2 центра

• CHRU de Brest — Brest
• Centre Hospitalier Universitaire de Saint-Etienne, Hôpital Nord — Saint-Priest-en-Jarez

Италия · 2 центра

• Fondazione IRCCS San Gerardo dei Tintori — Monza
• Fondazione IRCCS Policlinico San Matteo — Pavia

Чехия · 1 центр

• Vseobecna fakultni nemocnice v Praze — Prague

Великобритания · 1 центр

• Hammersmith Hospital — London

Идентификаторы

NCT: NCT07073820 · C5001004 · 2025-521155-23-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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