PAH Clinical Trial
Official title:
A Phase 2, Multi-Center, Open-Label Study to Evaluate Long-term Safety and Efficacy of CXA-10 in Subjects With Pulmonary Arterial Hypertension on Stable Background Therapy: Extension to Study CXA-10-301
This is a Phase 2, multicenter, open-label extension (OLE) of study CXA-10-301, to evaluate the long term safety and efficacy of daily dosing of CXA-10.
This is a Phase 2, multicenter, open-label extension (OLE) of study CXA-10-301, to evaluate
the long term safety and efficacy of daily dosing of CXA-10.
The study will be performed in approximately 50 study centers across the United States and
the United Kingdom, which participated in CXA-10-301. Approximately 96 subjects who completed
treatment in CXA-10-301 will be eligible to participate in this OLE study, after completing
all Visit 9 (Day 1 and Day 2) assessments in CXA-10-301.
Study participation for each subject will last up to approximately 6.5 months. The study will
consist of a 6 month open-label treatment period and require 5 clinic visits and 1 telephone
visit, including the Baseline Visit completed simultaneously with Visit 9 CXA-10-301, plus a
follow-up visit approximately 2 weeks following the last dose of CXA-10.
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