RECRUITINGPhase 1INTERVENTIONAL
A Study Evaluating the Safety and Tolerability of Artesunate in Patients With Pulmonary Arterial Hypertension
Phase I Study: A Dose-Escalation Study Evaluating the Safety and Tolerability of Artesunate in Patients With Pulmonary Arterial Hypertension
About This Trial
This is a 20-week, Phase 1, single-center, open-label, dose-escalation study evaluating the safety and tolerability of daily oral artesunate in patients with PAH.
Who May Be Eligible (Plain English)
Inclusion Criteria
- Each participant must meet the following criteria to be enrolled in this study:
- Adults aged 18 to 75 years.
- WHO functional class I, II/III despite treatment with maximally tolerated doses of 2 or more treatment modalities including PDE5 inhibitors, guanylate cyclase stimulators, endothelin receptor antagonists, and prostanoids when appropriate.
Exclusion Criteria
- Participants who meet any of the following criteria will be excluded from the study.
- Participants with serious concomitant morbidity per investigator assessment.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria
* Each participant must meet the following criteria to be enrolled in this study:
* Adults aged 18 to 75 years.
* WHO functional class I, II/III despite treatment with maximally tolerated doses of 2 or more treatment modalities including PDE5 inhibitors, guanylate cyclase stimulators, endothelin receptor antagonists, and prostanoids when appropriate.
Exclusion Criteria
* Participants who meet any of the following criteria will be excluded from the study.
* Participants with serious concomitant morbidity per investigator assessment.
Treatments Being Tested
DRUG
Artesunate
Participants will receive artesunate capsules. Participants will receive artesunate capsules TID in a dose escalation manner (60 mg, 120 mg, 180 mg total daily).
Locations (1)
Stanford University
Stanford, California, United States