Pulmonary Artery HypertensionNCT06035861
Endothelial Cell Activation and Total Pulmonary Resistance in PAH
A study testing XBD173 in people with Pulmonary Artery Hypertension, run by Imperial College London.
Trial summary
To determine whether changes in endothelial cell dysfunction are associated with changes in total pulmonary resistance in patients with pulmonary arterial hypertension Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Artery Hypertension
- What is being tested?
- XBD173
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Oct 2026
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged between 18-75 years old
- PAH which is: idiopathic; PAH heritable; PAH associated with connective tissue disease; PAH after ≥ 1 year repair of congenital systemic to pulmonary shunt; or PAH associated with anorexignes or other drugs.
- Resting mean pulmonary artery pressure ≥25 mmHg, pulmonary capillary wedge pressure ≤15 mmHg, PVR >5 wood units, and normal or reduced cardiac output, as measured by a previous right heart catheterisation (RHC).
- Have an insertable FDA/CE cardiac rhythm monitor and pulmonary artery pressure monitor that captures cardiopulmonary haemodynamics and daily activity.
- Six-minute walking distance >50m at entry
- Stable on an unchanged PAH therapeutic regime comprising at least 2 therapies licensed for PAH (any combination of endothelin receptor antagonist, phosphodiesterase inhibitor or prostacyclin analogue) for at least 1 month prior to screening
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- Subjects willing to be genotyped for genes that influence XBD173 activity
- Able to provide written informed consent prior to any study mandated procedures
- Contraception: Fertile females (women of childbearing potential) are eligible to participate after a negative highly sensitive pregnancy test, if they are taking a highly effective method of contraception other than the oral contraceptive pill during treatment and until the end of relevant systemic exposure
Who cannot join
- Unable to provide informed consent and/or are non-fluent speakers of the English language
- Hypersensitivity to XBD173 or to any of the excipients
- Clinically-significant renal disease (confirmed by creatinine clearance <30 ml/min per 1.73m2)
- Clinically-significant liver disease (confirmed by serum transaminases >2 times than upper normal limit)
- Anaemia confirmed by haemoglobin concentration <10 g/dl
- Individuals known to have haemoglobinopathy sickle cell disease, thalassaemia
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- Hospital admission related to PAH or change in PAH therapy within 3 months prior to screening
- History of left-sided heart disease and/or clinically significant cardiac disease, including but not limited to any of the following:
- Aortic or mitral valve disease (stenosis or regurgitation) defined as greater than mild aortic insufficiency, mild aortic stenosis, mild mitral stenosis, moderate mitral regurgitation
- Mechanical or bioprosthetic cardiac valve
- Pericardial constriction, effusion with tamponade physiology, or abnormal left atrial size.
- Restrictive or congestive cardiomyopathy
- Left ventricular ejection fraction ≤50% (measured in echocardiogram at screening)
- Symptomatic coronary disease
- Significant (2+ for regurgitation) valvular disease other than tricuspid or pulmonary regurgitation
- Acutely decompensated left heart failure within 1 month of screening
- History of untreated obstructive sleep apnoea
- Evidence of significant lung disease on high-resolution CT (if available) or recent (performed within 12 months) lung function, where FEV1 < 50% predicted and FVC < 70% predicted, and DLCO (or TLCO) < 50% predicted if any CT abnormalities; judged by the Site Physician
- Patients with a history of uncontrolled systemic hypertension
- Acute infection (including eye, dental, and skin infections)
- Chronic inflammatory disease including HIV, and Hepatitis B
- Women of childbearing potential who are pregnant or breastfeeding (if applicable)
- Patients who have received an Investigational Medicinal Product (IMP) within 5 half-lives of the last dose of the IMP or 1 month (which ever is greater) before the baseline visit
About this study
Official title: Investigating the Relationship Between Endothelial Cell Activation and Total Pulmonary Resistance in Pulmonary Artery Hypertension (PAH)
To determine whether changes in endothelial cell dysfunction are associated with changes in total pulmonary resistance in patients with pulmonary arterial hypertension
Read the detailed description
Patients with PAH will be exposed to XBD173. Markers of endothelial cell dysfunction and activation will be measured in the plasma, and changes in total pulmonary resistance will be meausured with an implantable monitor
- Conditions
- Pulmonary Artery Hypertension
- Being tested
- XBD173
- Medical subject headings
- Familial Primary Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XBD173Drug
Also called AC5216
Participants will be treated with XBD173 90mg twice daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| XBD173 | Experimental | 6 weeks exposure to XBD173 Receives: Drug: XBD173 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in plasma sVCAM1, e-selectin, GDF-15 and NT-proBNP
Percentage change in plasma markers
Measured: 6 weeks
Percentage change in total pulmonary resistance
Percentage change in total pulmonary resistance
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Aug 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Artery HypertensionStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035861
- Sponsor's protocol ID
- 22HH7807
- Status last verified
- Mar 2026
- First submitted
- 30 Aug 2023
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Relationship Between Endothelial Cell Activation and Total Pulmonary Resistance in Pulmonary Artery Hypertension (PAH)
- ClinicalTrials.gov ID
- NCT06035861
- Acronym / sponsor ID
- 22HH7807
- Conditions
- Pulmonary Artery Hypertension
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 13 Sep 2023 (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.
To determine whether changes in endothelial cell dysfunction are associated with changes in total pulmonary resistance in patients with pulmonary arterial hypertension
Detailed description
Patients with PAH will be exposed to XBD173. Markers of endothelial cell dysfunction and activation will be measured in the plasma, and changes in total pulmonary resistance will be meausured with an implantable monitor
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XBD173 | Experimental | Drug: XBD1736 weeks exposure to XBD173 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects aged between 18-75 years old
- PAH which is: idiopathic; PAH heritable; PAH associated with connective tissue disease; PAH after ≥ 1 year repair of congenital systemic to pulmonary shunt; or PAH associated with anorexignes or other drugs.
- Resting mean pulmonary artery pressure ≥25 mmHg, pulmonary capillary wedge pressure ≤15 mmHg, PVR >5 wood units, and normal or reduced cardiac output, as measured by a previous right heart catheterisation (RHC).
- Have an insertable FDA/CE cardiac rhythm monitor and pulmonary artery pressure monitor that captures cardiopulmonary haemodynamics and daily activity.
- Six-minute walking distance >50m at entry
Key exclusion criteria (23 listed)
- Unable to provide informed consent and/or are non-fluent speakers of the English language
- Hypersensitivity to XBD173 or to any of the excipients
- Clinically-significant renal disease (confirmed by creatinine clearance <30 ml/min per 1.73m2)
- Clinically-significant liver disease (confirmed by serum transaminases >2 times than upper normal limit)
- Anaemia confirmed by haemoglobin concentration <10 g/dl
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 |
|---|---|---|
| XBD173Also: AC5216Participants will be treated with XBD173 90mg twice daily for 6 weeks | Drug | XBD173 |
Primary outcome
Percentage change in plasma sVCAM1, e-selectin, GDF-15 and NT-proBNP
Time frame: 6 weeks
Percentage change in plasma markers
Percentage change in total pulmonary resistance
Time frame: 6 weeks
Percentage change in total pulmonary resistance
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 25 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing XBD173 in people with Pulmonary Artery Hypertension, run by Imperial College London.
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 9 inclusion and 23 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: opening soon, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in plasma sVCAM1, e-selectin, GDF-15 and NT-proBNP (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 25 Mar 2026.