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A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial Hypertension

CompletedPhase 2

Sponsor: Papworth Hospital NHS Foundation Trust

Conditions: Pulmonary Arterial Hypertension

Interventions: Tocilizumab

Countries: United Kingdom

An open label study to assess the safety and efficacy of tocilizumab in group 1 pulmonary arterial hypertension patients

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Group 1 PAH due to: Idiopathic or Heritable PAH, PAH associated with connective tissue disease excluding SLE, RA and mixed CTD, Drug and Toxins
* WHO functional class II-IV
* Weight more than 40kg
* 6 minute walk distance of 100-500 m
* Haemodynamic criteria measure by RHC
* Documented negative V/Q scan or pulmonary arteriogram confirming absence of chromic thromboembolic disease
* Resting oxygen saturations of \>85%
* Lung function confirming absence of significant lung disease
* Stable on unchanged PAH therapeutic regime for at least 1 month

Exclusion Criteria:

* Subjects on continuous infusions either intravenously or subcutaneously
* Hypersensitivity to Investigational Product
* Severe hepatic impairment
* Severe renal impairment
* Clinically significant anaemia
* Blood platelets \<100x10
* Neutrophil count \<2x10/L
* Left ventricular disease/dysfunction risk factors
* Myocardial infarction within 90 days prior to screening
* Female subjects who are pregnant or breastfeeding
* History of malignancies within past 5 years

Locations (1)

Cambridge, Cambridgeshire, United Kingdom