A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial Hypertension
- Sponsor
- Papworth Hospital NHS Foundation Trust
- Study ID
- NCT02676947
- Phase
- PHASE2
- Status
- Completed
Conditions
- Pulmonary Arterial Hypertension
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Tocilizumab — DRUG
Study Details
An open label study to assess the safety and efficacy of tocilizumab in group 1 pulmonary arterial hypertension patients
Key Dates
- Start date
- Jan 31, 2016
- Status verified
- Apr 2018
- Primary completion
- Feb 18, 2018
- Completion
- Feb 18, 2018
Study Design
- Enrollment
- 29 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Open LabelIntravenous Tocilizumab 8mg/kg monthly (up to a maximum dose 800mg) for 6 months
Primary Outcome Measure
Safety - Incidence and severity of adverse events [ Time Frame: 6 months ]
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- A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label ExtensionPHASE3 · Enrolling By Invitation · United Therapeutics · Phoenix, Arizona
- Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)Recruiting · V-Wave Ltd · Los Angeles, California