Tables
- TABLE 1
Potential pulmonary arterial hypertension (PAH) therapies currently in development
Therapy Clinical trial identifier Clinical trial design Primary end-points Treatment duration Status (October 2016) Therapies targeting inflammation and immunity Ubenimex NCT02664558 Phase II, multicentre, randomised, double-blind, placebo-controlled trial in PAH patients Change in PVR 24 weeks Recruiting [17] NCT02736149 Phase II, open-label, multicentre, extension study in PAH patients Frequency of adverse events ∼1 year Not yet recruiting [18] Rituximab NCT01086540 Phase II, randomised, double-blind, placebo-controlled trial in PAH-SSc patients Change in PVR 24 weeks Recruiting [19] Tocilizumab NCT02676947 Phase II, open-label trial in PAH patients Incidence and severity of adverse events; change in PVR 6 months Recruiting [20] Therapies targeting mitochondrial dysfunction Bardoxolone methyl NCT02036970 Phase II, double-blind, randomised, interventional trial in pulmonary hypertension Group I, II or V patients Change in 6MWD 16 weeks Preliminary results published [21] NCT02657356 Phase III, double-blind, early interventional trial in PAH-CTD patients Change in 6MWD 24 weeks Recruiting [22] GS-4997 NCT02234141 Phase II, dose-ranging, randomised, double-blind, placebo-controlled trial in PAH patients Change in PVR 24 weeks Ongoing, not recruiting [23] Therapies targeting BMPR2 signalling Tacrolimus NCT01647945 Phase II, double-blind, randomised trial in PAH patients Frequency of adverse events 16 weeks Terminated due to limited funding/slow patient recruitment; follow-up multicentre phase IIb efficacy trial planned [24] Therapies targeting iron deficiency Ferinject (ferric carboxymaltose) NCT01447628 Phase II, double-blind, randomised, interventional trial in IPAH, HPAH and anorexigen-associated PAH patients Change in PVR and exercise capacity 24 weeks Recruiting [25] NCT01847352 Single-blind, nonrandomised, interventional, trial in healthy volunteers who met iron-deficient or iron-replete criteria Change in PASP following i.v. iron infusion 1 week Completed: April 2014 [26, 27] Ferrous sulfate (oral dietary iron supplement) NCT01446848 Interventional, open-label study in IPAH patients with iron deficiency Change in zinc protoporphyrin level; change in serum ferritin level 12 weeks Completed: August 2014 [28] Pulmonary artery denervation Pulmonary arterial denervation procedure chiCTR-ONC-12002085 Phase II, observational, unblinded, nonrandomised study in PAH and PAH-CTD patients Change in PASP and 6MWD 24 weeks Completed: April 2014 [29] NCT02525926 Single-blind, randomised, interventional efficacy study in PAH patients Mean pulmonary artery pressure 26 weeks Recruiting [30] PVR: pulmonary vascular resistance (as measured by right heart catheterisation); PAH-SSc: PAH associated with systemic sclerosis; 6MWD: 6-min walk distance; PAH-CTD: PAH associated with connective tissue disease; BMPR2: bone morphogenetic protein receptor type 2; IPAH: idiopathic PAH; HPAH: heritable PAH; PASP: pulmonary artery systolic pressure.
Supplementary Materials
Supplementary Material
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N. Galie ERR-0084-2016_Galie
M. Hoeper ERR-0084-2016_Hoeper
V. McLaughlin ERR-0084-2016_McLaughlin
L. Rubin ERR-0084-2016_Rubin
G. Simonneau ERR-0084-2016_Simonneau
Vol 25 Issue 142
Table of Contents
Future perspectives in pulmonary arterial hypertension
