Open label extension of CXA-10 in Pulmonary Arterial Hypertension
Research type
Research Study
Full 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.
IRAS ID
269236
Contact name
Luke Howard
Contact email
Sponsor organisation
Complexa Inc.
Eudract number
2019-002414-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 15 days
Research summary
Patients with Pulmonary Arterial Hypertension (PAH) have high blood pressure in the blood vessels between their heart and lungs. These have become narrow, so the heart works harder, leading to a weakened heart. Patients are usually breathless on exertion, tired and can do less exercise. Noticeable symptoms of right heart failure show late in the disease. The 5-year survival rate for patients is 57%.
This study is an extension to protocol CXA-10-301. It will allow adult patients with PAH, who complete study CXA-10-301, to continue treatment with CXA-10 for an additional 6 months. It will see if CXA-10, a new study drug, can help improve heart health and to see if it is safe, over the long term. All patients will receive one 150mg dose of CXA-10 daily.
The study will be conducted in the USA and in approximately 6 sites in the UK. The UK sites are PAH centres. PAH patients who are being treated at the sites and who have completed CXA-10-301 will be invited to take part.
Each patient will be on the study for about 6.5 months. The study has:
• Baseline; may be completed as V9 of protocol CXA-10-301.
• Study Drug Period: 6 months.
• Follow-Up Period: About 14 days after the last dose of study drug, to check that patients are doing fine.
There are five clinic visits and one visit by phone. 5 visits are over-night fasted. Procedures will include one cardiac MRI, walking distance checks, blood draw every visit, ECGs, vital signs, physicals, urine samples, questionnaire completion, and blood oxygen levels.REC name
South Central - Oxford A Research Ethics Committee
REC reference
19/SC/0473
Date of REC Opinion
17 Dec 2019
REC opinion
Further Information Favourable Opinion