A Study Evaluating the Safety and Tolerability of Artesunate in Patients With Pulmonary Arterial Hypertension ((STOP-PAH))

Joseph C. Wu

Status and phase: Enrolling; Phase 1

Conditions: Pulmonary Arterial Hypertension (PAH)

Treatments: Drug: Artesunate

Study type: Interventional

Funder types: Other

Identifiers

NCT06872112

80578

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Open Label Treatment Arm

Experimental group

Description:

Dose escalating study with a Follow-up (washout) Period: Total study period of the open-label study: 14 weeks Screening Period: up to 4 weeks Treatment Period (20 mg TID): 4 weeks Treatment Period (40 mg TID): 4 weeks Treatment Period (60 mg TID): 4 weeks Follow-up (washout) Period: 2 weeks after treatment period ends

Treatment:

Drug: Artesunate