Pulmonary Arterial Hypertension (PAH)Phase 1(STOP-PAH)NCT06872112
A Study Evaluating the Safety and Tolerability of Artesunate in Patients With Pulmonary Arterial Hypertension
A Phase 1 study testing Artesunate in people with Pulmonary Arterial Hypertension (PAH), run by Joseph C. Wu at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pulmonary Arterial Hypertension (PAH)
- What is being tested?
- Artesunate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 1 Jan 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Participants who meet any of the following criteria will be excluded from the study.
- Participants with serious concomitant morbidity per investigator assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94305
Roham Zamanian, MD, (650) 725-7061, roham.zamanian@stanford.edu
About this study
Official title: Phase I Study: A Dose-Escalation Study Evaluating the Safety and Tolerability of Artesunate in Patients With Pulmonary Arterial Hypertension
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.
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Being tested
- Artesunate
- Keywords
- Pulmonary Arterial Hypertension, Artesunate, PAH
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Open Label Treatment Arm | Experimental | 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 Receives: Drug: Artesunate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start1 Apr 2026
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial Hypertension (PAH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joseph C. Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph C. Wu, Stanford University
- Investigators
- Roham Zamanian, MD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872112
- Sponsor's protocol ID
- 80578
- Acronym
- (STOP-PAH)
- Status last verified
- Apr 2026
- First submitted
- 6 Mar 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study: A Dose-Escalation Study Evaluating the Safety and Tolerability of Artesunate in Patients With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT06872112
- Acronym / sponsor ID
- (STOP-PAH) / 80578
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Keywords
- Pulmonary Arterial Hypertension, Artesunate, PAH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Joseph C. WuUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Treatment Arm | Experimental | Drug: ArtesunateDose 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Participants who meet any of the following criteria will be excluded from the study.
- Participants with serious concomitant morbidity per investigator assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArtesunateParticipants will receive artesunate capsules. Participants will receive artesunate capsules TID in a dose escalation manner (60 mg, 120 mg, 180 mg total daily). | Drug | Open Label Treatment Arm |
Primary outcome
Number of Participants with treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roham Zamanian, MD study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Artesunate in people with Pulmonary Arterial Hypertension (PAH), run by Joseph C. Wu at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.