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

Phase 1RecruitingNCT06872112

Joseph C. Wu15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Arterial Hypertension (PAH)

Interventions

ArtesunateDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ 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.

Locations (1)

Stanford University

Stanford, California, United States

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 16 weeks

Data from ClinicalTrials.gov

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