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
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