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

• Status: Completed
• Trial end date: 2018-02-18
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Papworth Hospital NHS Foundation Trust
• Collaborators: National Institute for Health Research, United Kingdom; Roche Pharma AG

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