Pulmonary Arterial HypertensionPhase 2APPROACH-2NCT04915300
Apabetalone for Pulmonary Arterial Hypertension
A Phase 2 study testing Apabetalone in people with Pulmonary Arterial Hypertension, run by Laval University at 1 site in Canada.
Trial summary
Throughout the past twenty years, numerous specific pharmacologic agents targeting the endothelial dysfunction associated with PAH have emerged. Short term placebo-controlled randomized trials assessing PAH-specific monotherapy with these molecules have reported improvements in pulmonary hemodynamics and exercise… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Apabetalone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2023to Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.
- Subject must be 18 to 75 years of age inclusive (18-80 years in case of PAH associated with scleroderma), at the time of signing the informed consent form.
- PAH of idiopathic/hereditary/drug or toxin-induced origin; or associated with connective tissue diseases or simple congenital heart disease (atrial septal defect, ventricular septal defect, patent ductus arteriosus) corrected for >1 year;
- Mean PA pressure >20mmHg, PVR >400 dyn.s.cm-5 with PA wedge pressure ≤15mmHg) and absence of acute vasoreactivity;
- WHO functional class II or III;
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- Clinically stable with unchanged vasoactive therapy for ≥3 months;
- Two 6MWD of ≥ 150m (the latter being used as baseline value);
- Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined as Absence of known liver cirrhosis, Haemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days, Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, Platelet count ≥ 100 x 109/L, Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 3.0 x institutional upper limit of normal and creatinine clearance estimated of ≥30 mL/min.
- Patients must have a life expectancy ≥ 28 weeks.
- Body mass index (BMI) within the range 18-40 kg/m2 (inclusive).
- Patients of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study treatment;
- Patients must be postmenopausal, free from menses for >1 year, surgically sterilized, willing to use adequate contraception to prevent pregnancy, or agree to abstain from activities that could result in pregnancy; and agree to abstain lactating from enrollment through 3 months after the last dose of study treatment.
- Male patients must use a condom during treatment and for 3 months after the last dose of apabetalone when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception (see appendix B for acceptable methods) if they are of childbearing potential.
Who cannot join
- PAH related to HIV infection, portal hypertension;
- Other types of pulmonary hypertension (Simonneau, Montani et al. 2019), including pulmonary related to left heart diseases, lung diseases, chronic thromboembolic disease or multifactorial mechanisms (PH groups 2-5, respectively);
- Suspected pulmonary veno-occlusive disease;
- A ventilation-perfusion lung scan or pulmonary angiography indicative of thromboembolic disease.
- Significant restrictive (total lung capacity <70% predicted) or obstructive (FEV1/FVC<60% after a bronchodilator) lung disease;
- DLCO <40%
Show all 28Show fewer
- Systolic blood pressure <90 mmHg;
- Resting heart rate in the awake patient at rest <50 BPM or >110 BPM;
- Acute RV failure or hospitalization within 30 days;
- Received any investigational drug within 30 days;
- Cardiopulmonary rehabilitation program planned or started ≤12 weeks prior to day 1;
- Presence of ≥3 risk factors for heart failure with preserved ejection fraction, including:
- BMI >30 kg/m2
- Diabetes mellitus
- Hypertension
- Coronary artery disease
- Recent cancer (<1yr, except for low grade and fully resolved non-melanoma skin cancer)
- Recent bacterial infection (<30 days);
- Anticipated survival less than 1 year due to concomitant disease.
- Initiation of treatment with bosentan within 6 months (bosentan has been associated with a 5-10% risk or reversible raised in LFTs. This most commonly occurs within the first 6 months of treatment. Although there is no evidence of increased risk of apabetalone-related increases in LFTs amongst bosentan users, patients initiated on bosentan for <6 months will be excluded to minimize the risk of elevated LFTs falsely attributed to the study drug).
- Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir). The required washout period prior to starting apabetalone is 2 weeks.*
- Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
- Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable, for timing refer to inclusion criteria no.7).
- Participation in another clinical study with an investigational product administered in the last 3 months
- Patients with a known hypersensitivity to apabetalone or any of the excipients of their formulations.
- Inability to consent
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
- Breast feeding women.
Trial locations and contacts
1 site in 1 country.
Canada1 site
IUCPQ-UL
Québec, G1V 4G5
Luce Bouffard, RN, 418-656-8711 ext. 2449, luce.bouffard@criucpq.ulaval.ca
Steeve Provencher, MD, MSc
About this study
Official title: Apabetalone for Pulmonary Arterial Hypertension: a Phase 2 Clinical Study
Throughout the past twenty years, numerous specific pharmacologic agents targeting the endothelial dysfunction associated with PAH have emerged. Short term placebo-controlled randomized trials assessing PAH-specific monotherapy with these molecules have reported improvements in pulmonary hemodynamics and exercise capacity. A recent meta-analysis also documented a reduction in short-term mortality of about ≈40% with such therapies. Several randomized clinical trials evaluating PAH-specific combination therapy have been conducted. Our recent meta-analysis showed that combination therapy was associated with a 35% risk reduction for the occurrence of clinical worsening compared to monotherapy. Nonetheless, the investigators also showed 17% of PAH patients receiving combination therapy still experienced clinical worsening over a median exposure of 16 weeks. Moreover, long-term survival on PAH-specific also therapy remains poor in the modern era, with a yearly mortality rate of 15 % in incident idiopathic PAH. The identification of innovative therapeutic targets and validation of these complementary therapeutic interventions are thus urgently needed in PAH.
The investigators and others (K. Stenmark, University of Colorado and H. Bogaard, VU University Medical Center, Amsterdam, personal communications), have published strong evidence that BRD4 plays a key role in the pathological phenotype in PAH accounting for disease progression and showed that BRD4 inhibition can reverse PAH in several animal models. Intriguingly, coronary artery disease (CAD) and metabolic syndrome are more prevalent in PAH compared with the global population, suggesting a link between these diseases. Interestingly, BRD4 is also a trigger for calcification and remodeling processes and regulates transcription of lipoprotein and inflammatory factors, all of which are important in PAH and CAD. Apabetalone, an orally available BRD4 inhibitor, is now in a clinical development stage with a good safety profile.
Read more
The overall objective of the study is to explore the efficacy and safety of apabetalone as an add-on therapy for adult PAH patients and to inform the conduct and the design of a Phase 3 trial.
The primary objective of the study is to assess the efficacy of apabetalone as evaluated by the change in PVR over a period of 24 weeks compared to placebo in adult subjects with PAH on stable background therapy.
Secondary objectives include changes at week 24 in 6MWD, plasma NT-proBNP concentration, WHO functional class, ESC/ERS risk stratification score, health-related quality of life and additional hemodynamic data from right heart.
Exploratory objectives are to evaluate the effects of apabetalone compared to placebo in adult subjects with PAH on mortality and clinically relevant morbidity events, and on circulating levels and transcription changes in whole blood markers of metabolism, vascular calcification, inflammation, DNA damage and leucocyte expression of BMPR2.
Read the detailed description
This is a standard-design, double-blind, parallel-group, placebo-controlled trial.
Overall, 72 well-characterized PAH patients, 36 subjects in each treatment group (apabetalone 100 mg BID or matching placebo), that have been stable for >4 months on standard PAH-therapies, as per guidelines (Galie, Humbert et al. 2015) will be recruited in 8-15 participating centres (site selection currently ongoing). The participating centres will be recruited if they have the same approach to PAH patients in terms of choice and timing of treatments, and have expertise in performing trials in PAH. The initial Health Canada approval will be obtained. Apabetalone will be provided by Resverlogix Corp. Canada, but Resverlogix had no input into the trial design and will not be involved in the conduct of the trial, analysis, interpretation of the results or the final manuscript.
A 4-week pre-treatment phase will allow ensuring that patients are on stable doses of PAH medication. Patients will be given apabetalone 100mg BID or placebo.
Patients will be regularly followed to assess whether side effects. At baseline and week 24, a cardiac catheterization will assess changes in pulmonary hemodynamics and RV function.
An end-of-study visit is planned at week 28.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Apabetalone, Placebo
- Keywords
- Bromodomain-Containing Protein 4 (BRD4), Apabetalone, Pulmonary Arterial Hypertension, BRD4 inhibitor, Phase 2 clinical trial, Double-blind trial, Placebo-controlled trial
- 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.
ApabetaloneDrug
Apabetalone 100mg p.o. (tablets) BID for 24 weeks treatment period.
PlaceboDrug
Placebo p.o. (tablets) BID for 24 weeks treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Apabetalone | Active comparator | 100mg BID, 24-week (168±3 days) Treatment Period. Receives: Drug: Apabetalone |
| Placebo | Placebo comparator | 24-week (168±3 days) period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo-corrected change from baseline in PVR at week 24
Right heart catheterization: Measuring PVR is performed in a standardized manner in catheterization laboratories of the participating centres, according to recommendations. Printed copies of waveforms will be kept for monitoring visits and documentation of the accuracy of the pressures and calculations.
Measured: Baseline, and 24 weeks later
Secondary outcomes (9)
Changes at week 24 in 6MWD
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
Measured: Baseline, week 8 and week 24
Changes at week 24 in plasma NT-proBNP concentration
Measured: Baseline, week 8 and week 24
Changes at week 24 in WHO functional class
There are four functional classes that are used to rate how ill PH patients are. Class I: No symptoms of pulmonary arterial hypertension with exercise or at rest. Class II: No symptoms at rest but uncomfortable and short of breath with normal activity such as climbing a flight of stairs, grocery shopping, or making the bed. Class III: May not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting. Class IV: Symptoms at rest and severe symptoms with any activity.
Measured: Baseline, week 8 and week 24
Changes at week 24 in European Respiratory Society (ERS)/European Society of Cardiology (ESC) risk stratification score
The ERS/ESC risk stratification strategy will be used to categorize patients as low, intermediate or high risk. The cut-off values proposed in the guidelines will be graded 1-3 (1: low-, 2: intermediate- and 3: high-risk). For each patient, the sum of all grades will be divided by the number of variables and rounded to the next integer to define the risk group. The number of low-risk criteria per patients will also be assessed.
Measured: Screening and Week 24
Change at week 24 in mean Pulmonary Artery Pressure (mPAP), mmHg obtained from right heart catheterization
The hemodynamic definition of pulmonary arterial hypertension (PAH) is a mean pulmonary artery pressure at rest greater than or equal to 25 mmHg in the presence of a pulmonary capillary wedge pressure less than or equal to 15 mmHg. These measurements can only be taken accurately during a right heart catheterization.
Measured: Screening and Week 24
Change in cardiac output (L/min)
Catheterization
Measured: Screening and Week 24
Change in right atrial pressure (RAP), mmHg
Catheterization
Measured: Screening and Week 24
Change in mixed venous oxygen saturation (SvO2), %
Catheterization
Measured: Screening and Week 24
Change at week 24 in HRQoL assessed using the EmPHasis-10 questionnaire
The Emphasis-10 questionnaire is a short questionnaire for assessing HRQoL in pulmonary arterial hypertension. It has excellent measurement properties and is sensitive to differences in relevant clinical parameters.
Measured: Screening and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study startOct 2023 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Laval 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
- Model description
- Randomized, double-blind, placebo-controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Resverlogix Corp
- Responsible party
- Principal investigator, Steeve Provencher, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Investigators
- Steeve Provencher, MD, MSc, Principal investigator, IUCPQ-ULPascale Blais-Lecours, PhD, Study director, IUCPQ-UL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915300
- Sponsor's protocol ID
- 2021-3625
- Acronym
- APPROACH-2
- Status last verified
- Apr 2023
- First submitted
- 19 May 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apabetalone for Pulmonary Arterial Hypertension: a Phase 2 Clinical Study
- ClinicalTrials.gov ID
- NCT04915300
- Acronym / sponsor ID
- APPROACH-2 / 2021-3625
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Bromodomain-Containing Protein 4 (BRD4), Apabetalone, Pulmonary Arterial Hypertension, BRD4 inhibitor, Phase 2 clinical trial, Double-blind trial, Placebo-controlled trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Resverlogix Corp
- Study start
- Oct 2023 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 7 Jun 2021 (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.
Throughout the past twenty years, numerous specific pharmacologic agents targeting the endothelial dysfunction associated with PAH have emerged. Short term placebo-controlled randomized trials assessing PAH-specific monotherapy with these molecules have reported improvements in pulmonary hemodynamics and exercise capacity. A recent meta-analysis also documented a reduction in short-term mortality of about ≈40% with such therapies. Several randomized clinical trials evaluating PAH-specific combination therapy have been conducted. Our recent meta-analysis showed that combination therapy was associated with a 35% risk reduction for the occurrence of clinical worsening compared to monotherapy. Nonetheless, the investigators also showed 17% of PAH patients receiving combination therapy still experienced clinical worsening over a median exposure of 16 weeks. Moreover, long-term survival on PAH-specific also therapy remains poor in the modern era, with a yearly mortality rate of 15 % in incident idiopathic PAH. The identification of innovative therapeutic targets and validation of these complementary therapeutic interventions are thus urgently needed in PAH.
The investigators and others (K. Stenmark, University of Colorado and H. Bogaard, VU University Medical Center, Amsterdam, personal communications), have published strong evidence that BRD4 plays a key role in the pathological phenotype in PAH accounting for disease progression and showed that BRD4 inhibition can reverse PAH in several animal models. Intriguingly, coronary artery disease (CAD) and metabolic syndrome are more prevalent in PAH compared with the global population, suggesting a link between these diseases. Interestingly, BRD4 is also a trigger for calcification and remodeling processes and regulates transcription of lipoprotein and inflammatory factors, all of which are important in PAH and CAD. Apabetalone, an orally available BRD4 inhibitor, is now in a clinical development stage with a good safety profile.
The overall objective of the study is to explore the efficacy and safety of apabetalone as an add-on therapy for adult PAH patients and to inform the conduct and the design of a Phase 3 trial.
The primary objective of the study is to assess the efficacy of apabetalone as evaluated by the change in PVR over a period of 24 weeks compared to placebo in adult subjects with PAH on stable background therapy.
Secondary objectives include changes at week 24 in 6MWD, plasma NT-proBNP concentration, WHO functional class, ESC/ERS risk stratification score, health-related quality of life and additional hemodynamic data from right heart.
Exploratory objectives are to evaluate the effects of apabetalone compared to placebo in adult subjects with PAH on mortality and clinically relevant morbidity events, and on circulating levels and transcription changes in whole blood markers of metabolism, vascular calcification, inflammation, DNA damage and leucocyte expression of BMPR2.
Detailed description
This is a standard-design, double-blind, parallel-group, placebo-controlled trial.
Overall, 72 well-characterized PAH patients, 36 subjects in each treatment group (apabetalone 100 mg BID or matching placebo), that have been stable for >4 months on standard PAH-therapies, as per guidelines (Galie, Humbert et al. 2015) will be recruited in 8-15 participating centres (site selection currently ongoing). The participating centres will be recruited if they have the same approach to PAH patients in terms of choice and timing of treatments, and have expertise in performing trials in PAH. The initial Health Canada approval will be obtained. Apabetalone will be provided by Resverlogix Corp. Canada, but Resverlogix had no input into the trial design and will not be involved in the conduct of the trial, analysis, interpretation of the results or the final manuscript.
A 4-week pre-treatment phase will allow ensuring that patients are on stable doses of PAH medication. Patients will be given apabetalone 100mg BID or placebo.
Patients will be regularly followed to assess whether side effects. At baseline and week 24, a cardiac catheterization will assess changes in pulmonary hemodynamics and RV function.
An end-of-study visit is planned at week 28.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Apabetalone | Active comparator | Drug: Apabetalone100mg BID, 24-week (168±3 days) Treatment Period. |
| Placebo | Placebo comparator | Drug: Placebo24-week (168±3 days) period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.
- Subject must be 18 to 75 years of age inclusive (18-80 years in case of PAH associated with scleroderma), at the time of signing the informed consent form.
- PAH of idiopathic/hereditary/drug or toxin-induced origin; or associated with connective tissue diseases or simple congenital heart disease (atrial septal defect, ventricular septal defect, patent ductus arteriosus) corrected for >1 year;
- Mean PA pressure >20mmHg, PVR >400 dyn.s.cm-5 with PA wedge pressure ≤15mmHg) and absence of acute vasoreactivity;
Key exclusion criteria (28 listed)
- PAH related to HIV infection, portal hypertension;
- Other types of pulmonary hypertension (Simonneau, Montani et al. 2019), including pulmonary related to left heart diseases, lung diseases, chronic thromboembolic disease or multifactorial mechanisms (PH groups 2-5, respectively);
- Suspected pulmonary veno-occlusive disease;
- A ventilation-perfusion lung scan or pulmonary angiography indicative of thromboembolic disease.
- Significant restrictive (total lung capacity <70% predicted) or obstructive (FEV1/FVC<60% after a bronchodilator) lung disease;
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 |
|---|---|---|
| ApabetaloneApabetalone 100mg p.o. (tablets) BID for 24 weeks treatment period. | Drug | Apabetalone |
| PlaceboPlacebo p.o. (tablets) BID for 24 weeks treatment period. | Drug | Placebo |
Primary outcome
Placebo-corrected change from baseline in PVR at week 24
Time frame: Baseline, and 24 weeks later
Right heart catheterization: Measuring PVR is performed in a standardized manner in catheterization laboratories of the participating centres, according to recommendations. Printed copies of waveforms will be kept for monitoring visits and documentation of the accuracy of the pressures and calculations.
9 secondary outcomes
Changes at week 24 in 6MWD
Time frame: Baseline, week 8 and week 24
Changes at week 24 in plasma NT-proBNP concentration
Time frame: Baseline, week 8 and week 24
Changes at week 24 in WHO functional class
Time frame: Baseline, week 8 and week 24
Changes at week 24 in European Respiratory Society (ERS)/European Society of Cardiology (ESC) risk stratification score
Time frame: Screening and Week 24
Change at week 24 in mean Pulmonary Artery Pressure (mPAP), mmHg obtained from right heart catheterization
Time frame: Screening and Week 24
Change in cardiac output (L/min)
Time frame: Screening and Week 24
Change in right atrial pressure (RAP), mmHg
Time frame: Screening and Week 24
Change in mixed venous oxygen saturation (SvO2), %
Time frame: Screening and Week 24
Change at week 24 in HRQoL assessed using the EmPHasis-10 questionnaire
Time frame: Screening and Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- 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. This study is not recruiting at the moment.
Steeve Provencher, MD, MSc principal investigator
IUCPQ-UL
Pascale Blais-Lecours, PhD study director
IUCPQ-UL
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 Apabetalone in people with Pulmonary Arterial Hypertension, run by Laval University at 1 site in Canada.
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 14 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 18 Apr 2023. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steeve Provencher, MD, MSc (418-656-4747, steeve.provencher@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placebo-corrected change from baseline in PVR at week 24 (time frame: Baseline, and 24 weeks later). 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 18 Apr 2023.