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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAOP Orphan Pharmaceuticals AG

About this trial

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.

Eligibility criteria

Qualifiers

Signed informed consent prior to any trial-mandated procedure

Male or female ≥ 18 and ≤ 70 years of age

idiopathic pulmonary arterial hypertension (IPAH)

hereditary pulmonary arterial hypertension (HPAH)

Disqualifiers

Schistosomiasis

HIV infection

Portal hypertension

Diffuse systemic sclerosis

Trial design

Treatments tested in this trial

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

Treatment groups

110 Participants
are divided into 2 treatment groups

Sponsors and collaborators

AOP Orphan Pharmaceuticals AG

Lead sponsor

ANOVA CRO s.r.o.

Collaborator

PharmaLex Belgium

Collaborator

Aixial s.r.o.

Collaborator

GCP-Service International Ltd. & Co. KG

Collaborator