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TREPROSTINIL in Pulmonary Hypertension: Evidence and Clinical Trends

26 juli 2026 bijgewerkt door: AOP Orphan Pharmaceuticals AG

Multicenter Registry Evaluating Real-World Therapeutic Patterns and Outcomes in Newly Diagnosed Adult Patients With Pulmonary Arterial Hypertension (PAH) Treated With Parenteral Treprostinil

TRESPECT is an international, multicenter, observational registry designed to describe the real-world use, effectiveness, and tolerability of parenteral treprostinil in adults with newly diagnosed pulmonary arterial hypertension (PAH). The registry will include patients who initiated subcutaneous or intravenous treprostinil within 12 months of PAH diagnosis.

Both retrospective and prospective data will be collected from routine clinical care. Data will include patient characteristics, PAH treatment patterns, treprostinil dosing and route of administration, functional status, exercise capacity, biomarkers, echocardiographic and hemodynamic parameters, clinical events, and adverse events. Participants will be followed for at least 36 months or until a registry termination criterion is met. The registry is expected to enroll approximately 100 to 300 patients across specialized PAH centers in several European countries.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Geschat)

300

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

The registry will include approximately 100-300 adult patients (≥18 years of age) with confirmed pulmonary arterial hypertension (PAH), classified as Group 1 according to the prevailing ESC/ERS guidelines, who initiated parenteral treprostinil administered subcutaneously or intravenously on or after January 1, 2024. Written informed consent will be required for prospective data collection and for retrospective medical chart review, as applicable under local regulations.

Beschrijving

Inclusion Criteria:

  • Adult patient (≥18 years)
  • Confirmed diagnosis of PAH (i.e. Group 1 as defined by ESC/ERS guidelines)
  • Initiated on parenteral Treprostinil (SC or IV) anytime from 1/1/2024
  • Informed consent (prospective data or retrospective chart review, per local regulations)

Exclusion Criteria:

  • Participation in any interventional trials affecting PAH (including patients from TripleTRE study)
  • Non-PAH forms of pulmonary hypertension (e.g., ESC-ERS Group 2-5)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Patients Treated With Parenteral Treprostinil
Adult patients with confirmed pulmonary arterial hypertension who initiated parenteral treprostinil administered by the subcutaneous or intravenous route within 12 months of PAH diagnosis. Treatment selection, route of administration, dosing, titration, concomitant PAH therapy, and clinical management are determined by the treating physician according to routine clinical practice. Clinical, treatment, safety, and outcome data are collected retrospectively and/or prospectively as part of this observational registry.
Geneesmiddel: treprostinil
Parenteral treprostinil administered by continuous subcutaneous or intravenous infusion as part of routine clinical care. The decision to initiate treatment, route of administration, starting dose, dose titration, treatment duration, and use of concomitant PAH therapies are determined by the treating physician and are not assigned by the registry. Data on treatment initiation, doses at approximately 2 and 4 weeks, longitudinal dosing, route of administration, tolerability, local site reactions, pain, treatment changes, and clinical outcomes are collected during registry follow-up.
Andere namen:
  • Parenteral Treprostinil
  • Subcutaneous Treprostinil
  • Intravenous Treprostinil

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean Change From Baseline in 6-Minute Walk Distance at Month 12
Tijdsspanne: Baseline and Month 12
Mean change in 6-minute walk distance from baseline to Month 12. The 6-minute walk distance is measured in meters. A positive change indicates improvement in exercise capacity.
Baseline and Month 12
Number and Percentage of Participants by Change in New York Heart Association Functional Class at Month 12
Tijdsspanne: Baseline and Month 12
Number and percentage of participants whose New York Heart Association Functional Class improved, remained unchanged, or worsened from baseline to Month 12. Functional Class ranges from Class I to Class IV, with a higher class indicating greater functional limitation.
Baseline and Month 12
Number and Percentage of Participants With Local Administration-Site Reactions During the First 12 Months
Tijdsspanne: From baseline through Month 12
Number and percentage of participants experiencing at least one local administration-site reaction associated with subcutaneous or intravenous treprostinil application during the first 12 months after treatment initiation.
From baseline through Month 12
Mean Local Pain Score During the First 12 Months
Tijdsspanne: Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, and Month 12
Local pain associated with parenteral treprostinil application will be assessed on a numerical rating scale from 0 to 10. Higher scores indicate greater pain.
Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, and Month 12

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean Change From Baseline in N-Terminal Pro-B-Type Natriuretic Peptide at Month 12
Tijdsspanne: Baseline and Month 12
Mean change in N-terminal pro-B-type natriuretic peptide concentration from baseline to Month 12.
Baseline and Month 12
Mean Change From Baseline in B-Type Natriuretic Peptide at Month 12
Tijdsspanne: Baseline and Month 12
Mean change in B-type natriuretic peptide concentration from baseline to Month 12.
Baseline and Month 12
Overall survival
Tijdsspanne: From initiation of parenteral treprostinil until death from any cause, assessed up to 36 months
Overall survival is defined as the time from initiation of parenteral treprostinil to death from any cause.
From initiation of parenteral treprostinil until death from any cause, assessed up to 36 months
Number and Percentage of Participants by Reason for Early Initiation of Parenteral Treprostinil
Tijdsspanne: Baseline
Number and percentage of participants in each documented category of clinical reason for initiating parenteral treprostinil within 12 months of PAH diagnosis, irrespective of baseline risk category.
Baseline
Mean Parenteral Treprostinil Dose at each visit
Tijdsspanne: Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
Parenteral treprostinil dose will be summarized at each visit. Dose will be reported in the unit ng/kg/min.
Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
Number and Percentage of Participants by Route of Parenteral Treprostinil Administration
Tijdsspanne: Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
Number and percentage of participants receiving parenteral treprostinil by subcutaneous or intravenous administration at each visit.
Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
Number and Percentage of Participants Receiving Concomitant Pulmonary Arterial Hypertension Therapy
Tijdsspanne: Baseline, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
Number and percentage of participants receiving each recorded category of concomitant pulmonary arterial hypertension therapy.
Baseline, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
Time to First Composite Clinical Worsening Event
Tijdsspanne: From initiation of parenteral treprostinil until the first composite clinical worsening event, assessed up to 36 months
Time from initiation of parenteral treprostinil to the first occurrence of death from any cause, PAH-related hospitalization, or lung transplantation.
From initiation of parenteral treprostinil until the first composite clinical worsening event, assessed up to 36 months
Number and Percentage of Participants With Adverse Events
Tijdsspanne: From baseline through Month 36
Number and percentage of participants experiencing at least one adverse event during registry follow-up. Adverse events will be summarized by seriousness, severity, outcome, causal relationship to treprostinil, and action taken with treatment.
From baseline through Month 36

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

AOP Orphan Pharmaceuticals AG

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 december 2029

Studie voltooiing (Geschat)

1 december 2031

Studieregistratiedata

Eerst ingediend

20 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

26 juli 2026

Eerst geplaatst (Werkelijk)

30 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

26 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • TRESPECT

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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