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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Participants will receive subcutaneous doses of PF-07868489 every 4 weeks
UCSF Health St. Mary's Hospital
San Francisco, California, United States
Heart and Vascular Center
San Francisco, California, United States
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, United States
Mount Sinai Hospital
New York, New York, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to week 111
Number of Participants With Change From Baseline in Laboratory Tests Results
Time frame: Baseline up to week 111
Number of Participants With Vital Sign Abnormalities
Time frame: Baseline up to week 111
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters
Time frame: Baseline up to week 111
Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration
Time frame: Baseline up to week 104
Minimum Observed Plasma Trough Concentration (Cmin), as data permits
Time frame: Baseline up to week 111
Incidence of Anti-Drug Antibody (ADA)
Time frame: Baseline up to week 111
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Pulmonary Hypertension Research Queensland Pty Ltd
Auchenflower, Queensland, Australia
HUB Hôpital Erasme
Brussels, Belgium
UZ Leuven
Leuven, Belgium
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
...and 17 more locations