The primary purpose of the study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PAH from studies INS1009-201 (NCT04791514), INS1009-202 (NCT05147805) and other lead-in studies of TPIP in participants with PAH.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
91
Administered by oral inhalation, using a Plastiape capsule-based dry powder inhaler.
Administered by oral inhalation using a Plastiape capsule-based dry powder inhaler
Number of Participants Who Experience at Least one Treatment Emergent Adverse Event (TEAE) and TEAEs by Severity
Time frame: From screening up to last follow up visit (Up to approximately 26 months)
Absolute Change From Pre-Open Label Extension (OLE) Baseline in 6-Minute Walk Distance (6MWD)
Time frame: Pre-OLE baseline (baseline of the lead-in TPIP study), Months 6, 12, 18, and 24
Relative Change From Pre-OLE Baseline in 6MWD
Time frame: Pre-OLE baseline (baseline of the lead-in TPIP study), Months 6, 12, 18, and 24
Change From Pre-OLE Baseline in the Concentration of N-Terminal Fragment B-Type Natriuretic Peptide (NT-proBNP) in Blood
Time frame: Pre-OLE baseline (baseline of the lead-in TPIP study), Months 6, 12, 18, and 24
Change From Pre-OLE Baseline in the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 Score
Time frame: Pre-OLE baseline (baseline of the lead-in TPIP study), Months 6, 12, 18, and 24
Change From Pre-OLE Baseline in New York Heart Association/ World Health Organization (NYHA/WHO) Functional Capacity Class
Time frame: Pre-OLE baseline (baseline of the lead-in TPIP study), Months 6, 12, 18, and 24
Annualized Clinical Worsening Event Rate
Annualized clinical worsening event rate is defined as the total number of clinical worsening events that occurred during the treatment period divided by the total number of participant-years during the treatment period. Clinical worsening events are one of the following: All-cause death, or onset of TEAE with a fatal outcome occurring ≤ 14 days after study drug discontinuation; Hospitalization for right heart failure (for \> 48 hours), heart-lung or lung transplant, or atrial septostomy; Addition (or increase in dose) of specified PAH-specific medications; Combined occurrence of events including ≥20% decrease in 6MWD, worsening WHO/NYHA functional capacity class, and appearance of or worsening of signs/symptoms of right heart failure from baseline.
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USA005
Jacksonville, Florida, United States
USA011
Tampa, Florida, United States
USA006
Chicago, Illinois, United States
USA001
Chicago, Illinois, United States
USA102
New York, New York, United States
USA016
Dallas, Texas, United States
ARG009
Quilmes, Buenos Aires, Argentina
ARG006
Rosario, Santa Fe Province, Argentina
ARG007
San Miguel de Tucumán, Tucumán Province, Argentina
ARG004
Córdoba, Argentina
...and 35 more locations
Time frame: OLE Baseline (Day 1) up to Month 24 or early discontinuation
Plasma Concentration Levels of Treprostinil Palmitil (TP) and Treprostinil (TRE)
Time frame: OLE Baseline (Day 1), Months 6, 12, 18, and 24