CXA-10 Study in Subjects With Pulmonary Arterial Hypertension
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|ClinicalTrials.gov Identifier: NCT04053543|
Recruitment Status : Terminated (LOE)
First Posted : August 12, 2019
Last Update Posted : August 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|PAH||Drug: CXA-10||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||CXA-10|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||August 9, 2019|
|Actual Primary Completion Date :||August 12, 2020|
|Actual Study Completion Date :||August 12, 2020|
Experimental: 150mg CXA-10
Once daily dosing of 150mg CXA-10 in the morning
- Incidence of AEs [ Time Frame: 6 months ]Adverse events occurring during the treatment period
- Changes in respiration [ Time Frame: 6 months ]Change from baseline values at each post-baseline time point
- Changes in heart rate [ Time Frame: 6 months ]Change from baseline values at each post-baseline time point
- Changes in blood pressure [ Time Frame: 6 months ]Change from baseline values at each post-baseline time point
- PAH-specific medication changes [ Time Frame: 6 months ]Addition or removal of PAH-specific medications, including any dose changes
- 6 Minute Walk Distance [ Time Frame: 6 months ]Change from baseline in 6-minute walk distance (6MWD)
- Who Classification of Functional Status [ Time Frame: 6 months ]Change from baseline in WHO Classification of Functional Status of Patients with PH
- Clinical worsening [ Time Frame: 6 months ]Death from any cause, hospitalization for worsening PAH, Disease progression, unsatisfactory long-term clinical response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04053543
|Study Director:||Theo Danoff, MD||Complexa, Inc.|