Pulmonary HypertensionPhase 2SATURNNCT05128929
Investigation of H01 in Adults With Pulmonary Hypertension Including Interstitial Lung Disease (The SATURN Study).
A Phase 2 study testing Hymecromone (H01) in people with Pulmonary Hypertension, run by Stanford University at 1 site in United States.
Trial summary
This study is a prospective, randomized, double-blind, study of H01 (Hymecromone) in adults with pulmonary hypertension (PH). The primary objective of this study is to evaluate the safety and tolerability of oral H01 and the potential benefit of oral H01 on clinical measures of PH disease severity over 24 weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Hymecromone (H01)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 29 Sep 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Classified as WHO functional class II/III/IV despite treatment with maximally tolerated doses of 2 or more treatment modalities (exp. PDE5 inhibitors, guanylate cyclase stimulators, endothelin receptor antagonists, and prostanoids)
- Baseline 6MWT: greater than 100 meters and less than 550 meters
- Established diagnosis of Group 3 pulmonary hypertension as a result of interstitial lung disease OR established diagnosis of Group 1 pulmonary hypertension as a result of connective tissue disease, idiopathic, hereditary, drugs, or toxins.
- Right heart catheterization at randomization showing pre-capillary pulmonary hypertension (mPAP ≥ 25 mmHg and PVR > 400 dynes * sec * cm^ -5) and:
- PCWP ≤20 mmHg for Group 3 PH patients and Group 1 PAH patients
- Participants on chronic medication for PAH, PH, or underlying lung disease must be on a stable and optimized dose for at least 90 days prior to the first dose of the study drug.
Show all 9Show fewer
- Female participants who are heterosexually active must use an acceptable method of contraception: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, IUD, or Hormone-based contraceptive
- Be able to provide written informed consent and comply with study requirements
- Be able to read, speak and understand English
Who cannot join
- Participants with a diagnosis of PAH or PH for reasons due to any of the following:
- Group 2, 4, or 5
- Group 1 due to HIV, veno-occlusive disease, porto-pulmonary hypertension, congenital heart disease
- Group 3 due to severe chronic obstructive pulmonary disease (COPD) or obstructive sleep apnea (OSA)
- Note: participants with overlapping syndromes will be evaluated on a case-by-case basis by the recruiting physician*
- Total Lung Capacity (TLC) less than 60% predicted
Show all 40Show fewer
- FEV1/FVC less than 50% predicted or FEV1 less than 55% predicted
- Inability to safely attempt completion of the 6MWD test
- Use of experimental PAH treatments within the past 3 months
- Current systemic treatment with hymecromone
- Left sided heart disease as defined by either a PCWP greater than 20 mmHg and/or left ventricular ejection fraction less than 40%
- Note: participants with abnormal left ventricular function attributable entirely to impaired left ventricular filling due to the effects of right ventricular overload (ie right ventricular hypertrophy and/or dilatation) are not excluded
- Participants must not have 3 or more of the following left ventricular disease / dysfunction risk factors:
- Body mass index (BMI) greater than 30kg/m2
- History of essential hypertension requiring medication
- Diabetes mellitus
- Historical evidence of significant coronary disease established by any of the following:
- History of myocardial infarction
- History of percutaneous coronary intervention or coronary artery bypass graft
- Angiographic evidence of greater than 50% stenosis in at least one coronary artery
- Positive stress test with imaging
- Stable angina
- Significant valvular heart disease as determined by more than moderate findings on echocardiogram or history of valve replacement
- Pregnant or actively breastfeeding
- Female participants with childbearing potential not willing to use a form of birth control (including abstinence) during the study
- Inability to undergo right heart catheterization
- Acute pulmonary embolism within 90 days of randomization
- Exacerbation of underlying lung disease or active pulmonary or upper respiratory infection within 30 days of randomizations
- Use of any inhaled tobacco products or significant history of drug abuse within 3 months prior to randomization
- Subject is receiving greater than 10L/min of oxygen supplementation by any mode of delivery at rest at baseline
- Body mass index greater than 40kg/m2
- Participants with history of dysphagia, achalasia, or difficulty swallowing capsules, tablets or pills
- Participants with liver failure or AST or ALT greater than 2 times the upper limit of normal
- Participants with total bilirubin levels greater than 2 times the upper limit of normal
- Participants with CrCl less than 45
- Use of any investigational drug/device, or participation in any investigational study with therapeutic intent within 30 days prior to randomization
- Known allergy to hymecromone or any component thereof
- Known allergy to any component of placebo (including wheat allergy, celiac disease, rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption)
- Physician concern that participant may not adhere to the study protocol
- Significant psychiatric, addictive, or other disorder that compromises the subject's ability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
This study is a prospective, randomized, double-blind, study of H01 (Hymecromone) in adults with pulmonary hypertension (PH). The primary objective of this study is to evaluate the safety and tolerability of oral H01 and the potential benefit of oral H01 on clinical measures of PH disease severity over 24 weeks.
Study Hypothesis:
Oral H01, at doses of 1600 mg per day, will be a safe and well-tolerated agent in adults with pulmonary hypertension over 24 weeks
Read the detailed description
The study's objectives are to evaluate:
- The changes in clinical and functional measures (pulmonary function test, pulmonary vascular resistance, mean pulmonary arterial pressure, and 6 Minute Walk Distance Test) in adults with PH treated with oral H01
- The safety and tolerability of the use of oral H01 for PH over 24 weeks using health criteria/evaluations (Common Terminology Criteria for Adverse Events (CTCAE), quality of life (QOL) score, EMPHASIS-10 score and St George Respiratory Questionnaire (SGRQ) score)
- To investigate the clinical efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) markers (serum HA concentration, inflammatory markers and cytokines, NT-proBNP, and H01 and metabolite serum concentrations) in this population following oral H01 use
- Conditions
- Pulmonary Hypertension
- Being tested
- Hymecromone (H01), Placebo
- Keywords
- Six Minute Walk Distance Test (6 MWDT), Right Heart Catheterization (RHC), Pulmonary Vascular Resistance (PVR), Pulmonary Function Test (PFT), Mean Pulmonary Arterial Pressure (mPAP), Pharmacokinetics, Pharmacodynamics, Hyaluronan, Hymecromone
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hymecromone (H01)Drug
Also called Cantabiline, Isochol
800 mg oral H01 two times a day (total dose: 1600 mg/day).
PlaceboDrug
Oral tablet placebo (inactive ingredients) two times a day.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment Oral Hymecromone (H01) | Experimental | Treatment will be initiated. Participants will be administered 800 mg of oral H01 two times a day (total dose: 1600 mg/day). Participants will continue to be on treatment for 24 weeks and will be monitored with assessments. Receives: Drug: Hymecromone (H01) |
| Placebo | Placebo comparator | Participants randomized to placebo will receive oral tablet placebo (inactive ingredients) two times a day. Participants will continue to be on placebo for 24 weeks and will be monitored with assessments. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculated Pulmonary Vascular Resistance (PVR)
Calculated pulmonary vascular resistance (PVR) measured by right heart catheterization (RHC).
A normal PVR ranges between 0.25 and 1.6 wood units (WU). Pre-capillary pulmonary hypertension is characterized by a PVR greater than 3 WU. Greater PVR is indicative of increased disease severity.
Either Fick or Thermodilution method can be utilized to measure cardiac output (CO) and calculate PVR. Fick method utilizes estimated oxygen consumption to measure CO and calculate PVR, while the thermodilution method utilizes temperature change to measure CO and calculate PVR.
All measurements to calculate PVR were obtained at end-expiration (measuring the pressures at functional residual capacity of the lungs).
Measured: Baseline to end of treatment (Week 24; +/- 7 days)
Secondary outcomes (7)
Number of Participants With Adverse Events by Severity Using the NIH Common Terminology Criteria for Adverse Events (CTCAE) as a Measure of Safety and Tolerability of H01 in Adults With Pulmonary Hypertension
- Grade 1: Mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
- Grade 2: Moderate minimal, local or noninvasive intervention indicated; limiting age- appropriate instrumental activities of daily living (ADL).
- Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL.
- Grade 4: Life-threatening consequences; urgent intervention indicated.
- Grade 5: Death related to AE.
Measured: Baseline to end of treatment (Week 24; +/- 7 days)
Mean Pulmonary Arterial Pressure (mPAP)
Mean pulmonary arterial pressure (mPAP) measured by RHC.
A normal mPAP ranges between 9 and 19 mmHg at rest. Pre-capillary pulmonary hypertension is characterized by a mPAP greater than 20 mmHg at rest. Greater mPAP is indicative of increased disease severity.
All measurements were obtained at end-expiration.
Measured: Baseline and end of treatment (Week 24; +/- 7 days)
6 Minute Walk Distance Test (6 MWDT)
The 6MWDT (distance walked in 6 minutes) is used to determine functional exercise capacity, assess treatment efficacy, predict prognosis, and establish rehabilitation programs in PAH/PH patients.
Measured: Screening (up to 30 days prior to baseline) and weeks 4 (+/- 3 days), 12 (+/- 3 days), and 24 (+/- 7 days).
EMPHASIS-10 Scale Score
Quality of life (QOL) assessed using the EMPHASIS-10 questionnaire.
The minimum score for this questionnaire is 0. The maximum score for this questionnaire is 50. Higher scores are indicative of poorer health-related quality of life (HRQoL) due to pulmonary hypertension.
Measured: Baseline and weeks 4 (+/- 3 days), 12 (+/- 3 days), and 24 (+/- 7 days)
St George Respiratory Questionnaire (SGRQ) Scale Score
Quality of life (QOL) assessed using the St George Respiratory Questionnaire (SGRQ).
There are a total of 3 components in the questionnaire, including symptoms, activity, and impacts. Each component has a minimum weight of 0, and a maximum weight of 662.5, 1209.1, and 2117.8, respectively. The minimum weight of the total score (combining all 3 components) is 0, and the maximum weight of total score is 3989.4.
The total score is calculated by dividing the summed weights from positive items in the questionnaire by the sum of weights for all items in the questionnaire and multiplying this by 100. The minimum total score is 0, the maximum is 100.
Lower scores indicate better health status.
Measured: Baseline and weeks 4 (+/- 3 days), 12 (+/- 3 days), and 24 (+/- 7 days)
Serum Hyaluronan (HA) Concentration
Two samples were collected at each time point and mean values were calculated. The average of the two mean values is reported.
The normal adult circulating level of hyaluronan ranges between 10 and 100 ng/mL.
Measured: Baseline and end of treatment (Week 24; +/- 7 days)
N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)
N-terminal pro-brain-type natriuretic peptide (NT-proBNP) is laboratory test used for assessing disease severity in pulmonary hypertension.
The normal ranges for NT-proBNP are as follows:
Male (Reflects 95th percentile w/o CHF ):
18-<44 yr: 36-93 pg/mL 44-<54 yr: 36-138 pg/mL 54-<64 yr: 36-177 pg/mL 64-<74 yr: 36-229 pg/mL 74 yr: 36-852 pg/mL
Females (Reflects 95th percentile w/o CHF ):
18-<44 yr: 36-178 pg/mL 44-<54 yr: 36-192 pg/mL 54-<64 yr: 36-226 pg/mL 64-<74 yr: 36-353 pg/mL >74 yr: 36-624 pg/mL
Measured: Baseline and weeks 4 (+/- 3 days), 12 (+/- 3 days), and 24 (+/- 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start1 Apr 2022
- Primary completion21 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roham T. Zamanian, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128929
- Sponsor's protocol ID
- H01
- Acronym
- SATURN
- Status last verified
- Oct 2024
- First submitted
- 11 Nov 2021
- Last updated
- 26 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Czepiel K, Nagy N, Panjalingam T, Kalinowski A, Frymoyer AR, Karmouty-Quintana H, Gu B, Hedlin H, Kaber G, Dobrota Lai S, Rosser JI, Bollyky PL, de Jesus Perez V, Zamanian RT. Randomised, placebo-controlled trial of oral hymecromone in adults with pulmonary hypertension. Thorax. 2025 Aug 15;80(9):632-640. doi: 10.1136/thorax-2024-222725.
PubMed 40451287Salman L, Martinez L, Faddoul G, Manning C, Ali K, Salman M, Vazquez-Padron R. Hyaluronan Inhibition as a Therapeutic Target for Diabetic Kidney Disease: What Is Next? Kidney360. 2023 Jun 1;4(6):e851-e860. doi: 10.34067/KID.0000000000000126. Epub 2023 Apr 14.
PubMed 37055910
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of H01 in Adults With Pulmonary Hypertension Including Interstitial Lung Disease (The SATURN Study).
- ClinicalTrials.gov ID
- NCT05128929
- Acronym / sponsor ID
- SATURN / H01
- Conditions
- Pulmonary Hypertension
- Keywords
- Six Minute Walk Distance Test (6 MWDT), Right Heart Catheterization (RHC), Pulmonary Vascular Resistance (PVR), Pulmonary Function Test (PFT), Mean Pulmonary Arterial Pressure (mPAP), Pharmacokinetics, Pharmacodynamics, Hyaluronan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Posted 26 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, randomized, double-blind, study of H01 (Hymecromone) in adults with pulmonary hypertension (PH). The primary objective of this study is to evaluate the safety and tolerability of oral H01 and the potential benefit of oral H01 on clinical measures of PH disease severity over 24 weeks.
Study Hypothesis:
Oral H01, at doses of 1600 mg per day, will be a safe and well-tolerated agent in adults with pulmonary hypertension over 24 weeks
Detailed description
The study's objectives are to evaluate:
- The changes in clinical and functional measures (pulmonary function test, pulmonary vascular resistance, mean pulmonary arterial pressure, and 6 Minute Walk Distance Test) in adults with PH treated with oral H01
- The safety and tolerability of the use of oral H01 for PH over 24 weeks using health criteria/evaluations (Common Terminology Criteria for Adverse Events (CTCAE), quality of life (QOL) score, EMPHASIS-10 score and St George Respiratory Questionnaire (SGRQ) score)
- To investigate the clinical efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) markers (serum HA concentration, inflammatory markers and cytokines, NT-proBNP, and H01 and metabolite serum concentrations) in this population following oral H01 use
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment Oral Hymecromone (H01) | Experimental | Drug: Hymecromone (H01)Treatment will be initiated. Participants will be administered 800 mg of oral H01 two times a day (total dose: 1600 mg/day). Participants will continue to be on treatment for 24 weeks and will be monitored with assessments. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants randomized to placebo will receive oral tablet placebo (inactive ingredients) two times a day. Participants will continue to be on placebo for 24 weeks and will be monitored with assessments. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Classified as WHO functional class II/III/IV despite treatment with maximally tolerated doses of 2 or more treatment modalities (exp. PDE5 inhibitors, guanylate cyclase stimulators, endothelin receptor antagonists, and prostanoids)
- Baseline 6MWT: greater than 100 meters and less than 550 meters
- Established diagnosis of Group 3 pulmonary hypertension as a result of interstitial lung disease OR established diagnosis of Group 1 pulmonary hypertension as a result of connective tissue disease, idiopathic, hereditary, drugs, or toxins.
- Right heart catheterization at randomization showing pre-capillary pulmonary hypertension (mPAP ≥ 25 mmHg and PVR > 400 dynes * sec * cm^ -5) and:
- Participants on chronic medication for PAH, PH, or underlying lung disease must be on a stable and optimized dose for at least 90 days prior to the first dose of the study drug.
Key exclusion criteria (40 listed)
- Participants with a diagnosis of PAH or PH for reasons due to any of the following:
- Total Lung Capacity (TLC) less than 60% predicted
- FEV1/FVC less than 50% predicted or FEV1 less than 55% predicted
- Inability to safely attempt completion of the 6MWD test
- Use of experimental PAH treatments within the past 3 months
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 |
|---|---|---|
| Hymecromone (H01)Also: Cantabiline, Isochol800 mg oral H01 two times a day (total dose: 1600 mg/day). | Drug | Experimental Treatment Oral Hymecromone (H01) |
| PlaceboOral tablet placebo (inactive ingredients) two times a day. | Drug | Placebo |
Primary outcome
Calculated Pulmonary Vascular Resistance (PVR)
Time frame: Baseline to end of treatment (Week 24; +/- 7 days)
Calculated pulmonary vascular resistance (PVR) measured by right heart catheterization (RHC). A normal PVR ranges between 0.25 and 1.6 wood units (WU). Pre-capillary pulmonary hypertension is characterized by a PVR greater than 3 WU. Greater PVR is indicative of increased disease severity. Either Fick or Thermodilution method can be utilized to measure cardiac output (CO) and calculate PVR. Fick method utilizes estimated oxygen consumption to measure CO and calculate PVR, while the thermodilution method utilizes temperature change to measure CO and calculate PVR. All measurements to calculate PVR were obtained at end-expiration (measuring the pressures at functional residual capacity of the lungs).
7 secondary outcomes
Number of Participants With Adverse Events by Severity Using the NIH Common Terminology Criteria for Adverse Events (CTCAE) as a Measure of Safety and Tolerability of H01 in Adults With Pulmonary Hypertension
Time frame: Baseline to end of treatment (Week 24; +/- 7 days)
Mean Pulmonary Arterial Pressure (mPAP)
Time frame: Baseline and end of treatment (Week 24; +/- 7 days)
6 Minute Walk Distance Test (6 MWDT)
Time frame: Screening (up to 30 days prior to baseline) and weeks 4 (+/- 3 days), 12 (+/- 3 days), and 24 (+/- 7 days).
EMPHASIS-10 Scale Score
Time frame: Baseline and weeks 4 (+/- 3 days), 12 (+/- 3 days), and 24 (+/- 7 days)
St George Respiratory Questionnaire (SGRQ) Scale Score
Time frame: Baseline and weeks 4 (+/- 3 days), 12 (+/- 3 days), and 24 (+/- 7 days)
Serum Hyaluronan (HA) Concentration
Time frame: Baseline and end of treatment (Week 24; +/- 7 days)
N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)
Time frame: Baseline and weeks 4 (+/- 3 days), 12 (+/- 3 days), and 24 (+/- 7 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40451287Czepiel K, Nagy N, Panjalingam T, Kalinowski A, Frymoyer AR, Karmouty-Quintana H, Gu B, Hedlin H, Kaber G, Dobrota Lai S, Rosser JI, Bollyky PL, de Jesus Perez V, Zamanian RT. Randomised, placebo-controlled trial of oral hymecromone in adults with pulmonary hypertension. Thorax. 2025 Aug 15;80(9):632-640. doi: 10.1136/thorax-2024-222725.
- Derived from this study: PubMed 37055910Salman L, Martinez L, Faddoul G, Manning C, Ali K, Salman M, Vazquez-Padron R. Hyaluronan Inhibition as a Therapeutic Target for Diabetic Kidney Disease: What Is Next? Kidney360. 2023 Jun 1;4(6):e851-e860. doi: 10.34067/KID.0000000000000126. Epub 2023 Apr 14.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hymecromone (H01) in people with Pulmonary Hypertension, run by Stanford University 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 9 inclusion and 40 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: finished, as of the sponsor's last update on 26 Nov 2024. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Calculated Pulmonary Vascular Resistance (PVR) (time frame: Baseline to end of treatment (Week 24; +/- 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05128929, which also lists 2 linked publications.
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 26 Nov 2024.