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Studies

Interventional Recruiting Phase 4

NCT06317805 on ClinicalTrials.gov

Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients

Official title: Randomized Trial Comparing Efficacy and Safety of Initial Triple Therapy Including Parenteral Treprostinil to Initial Double Oral Therapy in Pulmonary Arterial Hypertension (PAH) Group I Patients (TripleTRE)

  • Sponsor: AOP Orphan (Austria)
  • Collaborators: ANOVA CRO s.r.o., PharmaLex Belgium, Aixial s.r.o., GCP-Service International Ltd. & Co. KG
  • Enrollment: 110 (Estimated)
  • Study start: 2023-12-06 (Actual)
  • Primary completion: 2027-06-01 (Estimated)
  • Study completion: 2027-06-30 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Prospective, randomized, two-arm, open-label, low-interventional, phase IV, multi-centre clinical trial comparing efficacy and safety of initial triple therapy including parenteral treprostinil to initial double oral therapy (background therapy with endothelin receptor antagonist - ERA and phosphodiesterase type-5 inhibitor - PDE-5i) by proportion of patients achieving low risk status according to the simplified four-strata risk-assessment tool from week 24 up to 48 weeks in 110 (55/group) treatment-naïve adult intermediate-high risk or intermediate-low risk patients with severe hemodynamic impairment with pulmonary arterial hypertension (PAH) (group I).
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

TripleTRE investigates the effect of initial triple combination therapy (oral endothelin receptor antagonist (ERA) + oral phosphodiesterase tyüe-5 inhibitor (PDE-5i) + parenteral treprostinil) compared to double oral therapy (oral ERA + oral PDE-5i) in pulmonary arterial hypertension (PAH) patients (group I) with intermediate-high risk or patients with intermediate-low risk with severe hemodynamic impairment at baseline in a prospective, randomized, unblinded setting with scope of increasing evidence for optimization of therapy concepts in PAH.

The effect of initial triple combination therapy vs initial double oral therapy (standard of care (SoC)) will be measured by primary endpoint: (non)response to the assigned treatment.

Conditions

  • Pulmonary Arterial Hypertension

Intervention / Treatment

  • Drug: Generic treprostinil sodium + Standard of Care (Double Oral)
  • Drug: Standard of Care - Double Oral

Primary Outcome Measures

  • Patients achieving (non-)response status to the assigned treatment in terms of achievement of low-risk status (between week 12 and week 48 from baseline (BL))
    1. Therapy-responder: achievement of low-risk status between week 24 and week 48 2. Therapy-non-responder: 1. PH related deterioration to high-risk status, lung transplantation or death between week 12 and week 48 and/or 2. additional medication or change of initial PH specific medication due to unsatisfactory efficacy between week 12 and week 48 and/or 3. low risk status not achieved up to week 48 Risk status is assessed with the simplified four-strata risk-assessment tool as per PH guidelines.

Countries

Argentina, Austria, Czechia, France, Germany, Hungary, Italy, Poland, Portugal, Romania, Spain, Uruguay

Locations and Investigators

  • Instituto Neumonológico del Sur (INEUS), Bahía Blanca, Argentina (Active not recruiting)
  • Centro Gallego de Buenos Aires, Buenos Aires, Argentina (Active not recruiting)
  • Fundación Favaloro, Buenos Aires, Argentina (Active not recruiting)
  • Hospital Británico de Buenos Aires, Buenos Aires, Argentina (Active not recruiting)
  • Hospital Italiano de Buenos Aires (HIBA), Buenos Aires, Argentina (Active not recruiting)
  • Hospital Ramos Mejia, Buenos Aires, Argentina (Active not recruiting)
  • Sanatorio Mitre de Buenos Aires, Buenos Aires, Argentina (Active not recruiting)
  • Centro Médico Capital, La Plata, Argentina (Active not recruiting)
  • Ordensklinikum Linz, Linz, Austria (Recruiting)
    • Regina Steringer-Mascherbauer
    • Regina Steringer-Mascherbauer (Principal Investigator)
  • Medical University Vienna, Vienna, Austria (Recruiting)
    • Irene Lang
    • Irene Lang (Principal Investigator)
  • Fakultní Nemocnice Olomouc, Olomouc, Czechia (Not yet recruiting)
    • Jan Přeček
    • Jan Přeček (Principal Investigator)
  • Všeobecná fakultní nemocnice v Praze, Prague, Czechia (Not yet recruiting)
    • Pavel Jansa
    • Pavel Jansa (Principal Investigator)
  • Hôpital Bicêtre-- Assistance Publique Hopitaux de Paris, Paris, France (Not yet recruiting)
    • Olivier Sitbon
    • Olivier Sitbon (Principal Investigator)
  • Hôpitaux Universitaires de Strasbourg, Strasbourg, France (Not yet recruiting)
    • Marianne Riou
    • Marianne Riou (Principal Investigator)
  • DRK Kliniken Berlin Westend, Berlin, Germany (Not yet recruiting)
    • Christian Opitz
    • Christian Opitz (Principal Investigator)
  • University Hospital Carl Gustav Carus of Technical University Dresden, Dresden, Germany (Not yet recruiting)
    • Michael Halank
    • Michael Halank (Principal Investigator)
  • Universitätsmedizin Greifswald, Greifswald, Germany (Not yet recruiting)
    • Ralf Ewert
    • Ralf Ewert (Principal Investigator)
  • Gottsegen National Cardiovascular lnstitute, Budapest, Hungary (Not yet recruiting)
    • Olga Hajnalka Balint
    • Olga Hajnalka Balint (Principal Investigator)
  • Medical University of Szeged, Szeged, Hungary (Not yet recruiting)
    • Gergely Ágoston
    • Gergely Ágoston (Principal Investigator)
  • Sapienza University of Rome, Rome, Italy (Recruiting)
    • Roberto Badagliacca
    • Roberto Badagliacca (Principal Investigator)
  • John Paul II Hospital Krakow, Krakow, Poland (Not yet recruiting)
    • Grzegorz Kopeć
    • Grzegorz Kopeć (Principal Investigator)
  • Fryderyk Chopin Hospital in European Health Centre Otwock, Otwock, Poland (Not yet recruiting)
    • Marcin Kurzyna
    • Marcin Kurzyna (Principal Investigator)
  • Centro Hospitalar Lisboa Norte - Santa Maria University Hospital, Lisbon, Portugal (Not yet recruiting)
    • Rui Miguel Freire Plácido
    • Rui Miguel Freire Plácido (Principal Investigator)
  • Emergency Institute for Cardiovascular Diseases Prof. Dr. C.C.Iliescu, Bucharest, Romania (Not yet recruiting)
    • Ioan Mircea Coman
    • Ioan Mircea Coman (Principal Investigator)
  • Emergency Clinical County Hospital of Targu Mures, Târgu Mureş, Romania (Not yet recruiting)
    • Ioan Tilea
    • Ioan Tilea (Principal Investigator)
  • Hospital Clinic of Barcelona, Barcelona, Spain (Not yet recruiting)
    • Isabel Blanco Vich
    • Isabel Blanco Vich (Principal Investigator)
  • Hospital Ramon y Cajal, Madrid, Spain (Not yet recruiting)
    • Jose Andres Tenes Mayen
    • Jose Andres Tenes Mayen (Principal Investigator)
  • Hospital Maciel, Montevideo, Uruguay (Active not recruiting)