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New treatment option for Pulmonary Artery Hypertension
Official title Sotatercept in Pulmonary Arterial Hypertension
ClinicalTrials.gov ID: NCT07140484
What this study is testing
What is Sotatercept?
Sotatercept is an investigational medicine, being studied as a potential treatment for pulmonary artery hypertension.
Also referred to as Winrevair.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to determine whether sotatercept is effective in improving diffusing capacity in patients with pulmonary arterial hypertension. Participants will be asked to: Take Sotatercept every 21 days (±3 days) Each participant will be enrolled in the study for 29 Weeks Visit the clinic 18 times Have a physical exam Perform assessments of lung function and exercise tests Have an ultrasound of their heart Have blood draws done at regular intervals The main objectives of the study are: Primary objective: To assess whether sotatercept will improve recruitment of diffusing membrane capacity (DM) with exercise.
- Phase 4: studies an already-approved treatment
- Time commitment: about 2 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Eligible participants must meet all of the following to be enrolled in the study:
- Age ≥ 18 years.
- Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of PAH Group 1 in any of the...
- Idiopathic PAH
- Heritable PAH
You likely can't join if
- 1\. Diagnosis of pulmonary hypertension WHO Groups 2, 3, 4, or 5
- Musculoskeletal limitation that precludes participation in cycle ergometry
- Resting oxygen saturation \< 88%. (Note: patients on oxygen can be included in the study if they can maintain a resting saturation of ≥ 88 % after 3...
- Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension...
- Hemoglobin (Hgb) at screening above the gender-specific upper limit of normal (ULN), per local laboratory test.
- Baseline platelet count \< 50,000/mm3 (\< 50.0 × 109/L) in the enrollment period.
See the full eligibility criteria
Who can join
- Eligible participants must meet all of the following to be enrolled in the study:
- Age ≥ 18 years.
- Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of PAH Group 1 in any of the following subtypes:
- Idiopathic PAH
- Heritable PAH
- Drug/toxin-induced PAH
- PAH associated with CTD
- PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair.
- Symptomatic PAH classified as WHO FC II or III.
- On stable doses of ≥2 background PAH therapies for at least 60 days prior to screening; for infusion prostacyclins, dose adjustment within 10% of the optimal dose is allowed per medical practice. Patients on 1...
- Females of childbearing potential must:
- Have a negative urine or serum pregnancy tests as verified by the investigator prior to starting study therapy.
- If sexually active, have used, and agree to use highly effective contraception without interruption during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study treatment.
- Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study treatment.
- Male participants must:
- Agree to use a condom, defined as a male latex condom or nonlatex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential...
- Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study treatment
- Ability to adhere to study visit schedule and understand and comply with all protocol requirements.
- Ability to understand and provide written informed consent.
What rules you out
- 1\. Diagnosis of pulmonary hypertension WHO Groups 2, 3, 4, or 5
- Musculoskeletal limitation that precludes participation in cycle ergometry
- Resting oxygen saturation \< 88%. (Note: patients on oxygen can be included in the study if they can maintain a resting saturation of ≥ 88 % after 3 minutes off oxygen).
- Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension, schistosomiasis-associated PAH and pulmonary veno-occlusive disease.
- Hemoglobin (Hgb) at screening above the gender-specific upper limit of normal (ULN), per local laboratory test.
- Baseline platelet count \< 50,000/mm3 (\< 50.0 × 109/L) in the enrollment period.
- Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure \> 160 mmHg or sitting diastolic blood pressure \> 100 mmHg during a screening visit after a period of rest.
- Baseline systolic blood pressure \< 90 mmHg at screening.
- Pregnant or breastfeeding women.
- Any of the following clinical laboratory values at the screening visit:
- Estimated glomerular filtration rate (eGFR) \< 30 mL/min/m2 (as defined by the Modification of Diet in Renal Disease [MDRD] equation)
- Serum alanine aminotransferase, aspartate aminotransferase, or total bilirubin levels \> 3 × ULN (bilirubin criterion waived if there is a documented history of Gilbert's syndrome).
- Currently enrolled in or have completed any other investigational product study within 30 days for small-molecule drugs or within 5 half-lives for biologics prior to the date of signed informed consent.
- History of full pneumonectomy.
- Pulmonary function test (PFT) values of forced vital capacity (FVC) \< 60% predicted and/or FEV1/FVC \< lower limit of normal at the screening visit or within 6 months prior to the screening visit.
- Smoking history of ≥ 20 pack-years or any tobacco smoking or vaping within the previous 3 months.
- Body mass index ≥ 40 kg/m2.
- Planned initiation of an exercise program for cardiopulmonary rehabilitation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are...
- Known history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), defined as mild to severe hepatic impairment...
- History of restrictive, constrictive, or congestive cardiomyopathy.
- History of atrial septostomy within 180 days prior to the screening visit.
- Electrocardiogram (ECG) with Fridericia's corrected QT interval (QTcF) \> 500 ms during the Screening Period
- Personal or family history of long QT syndrome (LQTS) or sudden cardiac death.
- Left ventricular ejection fraction \< 45% on historical echocardiogram within 6 months prior to the screening visit.
- Any symptomatic coronary disease events (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months prior to the screening...
- Cerebrovascular accident within 3 months prior to the Screening Visit.
- Significant mitral or aortic valve dysfunction (greater than moderate mitral regurgitation or aortic regurgitation, or greater than mild mitral stenosis or aortic stenosis).
- Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to the screening visit.
- Known hypersensitivity to sotatercept or to any ingredient in the formulation or component of the container.
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.