NCT04125745

Oral CXA-10 in Pulmonary Arterial Hypertension

Phase 2 Open-Label Study of Safety and Efficacy Trial of CXA-10 in Pulmonary Arterial Hypertension

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Gladwin, Mark, MD · Individual
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to evaluate the safety and tolerability of 12-week oral CXA-10 therapy in subjects with pulmonary arterial hypertension, with additional evaluation on the clinical efficacy of oral CXA-10 on changes in hemodynamics, exercise capacity, cardiovascular function and patient reported outcomes.

Detailed description

This is a single-center, one-arm, open-label proof of concept safety study and a phase 2a proof of efficacy pre- and post-assessment study of oral CXA-10 for the treatment of pulmonary arterial hypertension. The investigators hypothesize that administration of CXA-10 for 12 weeks will improves exercise capacity, cardiovascular function and health related quality of life in pulmonary arterial hypertension patients with limited toxicity. Subjects who meet the inclusion criteria and none of the exclusion criteria will be scheduled within 4 weeks of screening to receive oral CXA-10 at the dose of 300 mg once daily followed by 12 weeks of open-label CXA-10 treatment and then a 4-week safety follow-up. Additional follow-up assessments by telephone will occur in between each outpatient clinic visit.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	CXA-10	Each subject will receive oral CXA-10 at the dose of 300 mg once daily for 12 weeks

Timeline

• Start date: 2019-10-31
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2019-10-14
• Last updated: 2022-01-12
• Results posted: 2022-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study