A Study Evaluating the Safety and Tolerability of Artesunate in Patients With Pulmonary Arterial Hypertension

ConditionPulmonary Arterial Hypertension (PAH)

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-60

SponsorJoseph C. Wu

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Participants who meet any of the following criteria will be excluded from the study.

Participants with serious concomitant morbidity per investigator assessment.

Trial design

Design model

Single group

Treatments tested in this trial

Artesunate
Drug
Participants will receive artesunate capsules. Participants will receive artesunate capsules TID in a dose escalation manner (60 mg, 120 mg, 180 mg total daily).

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: Open Label Treatment ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Number of Participants with treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame

16 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Joseph C. Wu

Lead sponsor

Stanford University

Sponsor institution

Source ClinicalTrials.gov

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