The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
550
Tablet, oral administration, 10 mg dose once daily
Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to 28 Days After Study Treatment Discontinuation
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE are defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline.
Time frame: Up to 28 days after study treatment discontinuation (Up to 12 years)
Number of Participants With Death up to 28 Days After Study Treatment Discontinuation
Number of participants with deaths up to 28 days after study treatment discontinuation were reported.
Time frame: Up to 28 days after study treatment discontinuation (Up to 12 years)
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) up to 28 Days After Study Treatment Discontinuation
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE are defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically significant, or requires intervention to prevent at least one of the outcomes listed above.
Time frame: Up to 28 days after study treatment discontinuation (Up to 12 years)
Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment
Number of participants with AEs leading to permanent discontinuation of study treatment were reported. An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time frame: Up to 28 days after study treatment discontinuation (Up to12 years)
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Pulmonary Specialists
Phoenix, Arizona, United States
University of California, San Diego
La Jolla, California, United States
GLVA Healthcare Center
Los Angeles, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
Liu Center for Pulmonary Hypertension
Torrance, California, United States
University of Colorado CARDIAC AND VASCULAR CENTER
Aurora, Colorado, United States
University of Florida - Division of Pulmonology
Gainesville, Florida, United States
Mayo Clinic, Jacksonville
Jacksonville, Florida, United States
Emory University Hospital - McKelvey Center for Lung Transplantation & Pulmonary Vascular Disease
Atlanta, Georgia, United States
...and 148 more locations
Number of Participants With Treatment Emergent Abnormal Liver Tests up to 28 Days After Study Treatment Discontinuation
Number of participants with treatment-emergent abnormal liver tests: Alanine aminotransferase (ALT) greater than (\>) 3\*upper limit of normal (ULN) or aspartate aminotransferase (AST) \>3\* ULN, ALT \>5\* ULN or AST \>5\*ULN, ALT \>8\*ULN or AST \>8\*ULN, total bilirubin (TBIL) \>2\*ULN, ALT \>3\*ULN or AST \>3\*ULN and TBIL \>2\*ULN at any time were reported.
Time frame: Up to 28 days after study treatment discontinuation (Up to12 years)
Number of Participants With Treatment Emergent Hemoglobin Abnormality up to 28 Days After Study Treatment Discontinuation
Number of participants with treatment-emergent hemoglobin (HGB) abnormality up to 28 days after study treatment discontinuation were reported. Participants assessed for different categories of HGB were \<=80 grams/Liter (g/L), \<=100g/L, decrease from baseline \>=20 g/L, and decrease from baseline \>=50 g/L.
Time frame: Up to 28 days after treatment discontinuation (Up to 12 years)