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A clinical study of sotatercept in people with pulmonary hypertension (MK-7962-023)
EU CTIS ID: 2024-515773-99-00
What this study is testing
To evaluate the long-term safety and tolerability of sotatercept for up to 42 months of treatment
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Completed MK-7962-007 (CADENCE) (Visit 9 and EOT visit) without discontinuing study intervention and is able to safely enroll into MK-7962-007 (HARMONIZE)
You likely can't join if
- Has a diagnosis of pulmonary hypertension (PH) in world health organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5
- Has had a study intervention interruption
- Is pregnant or breastfeeding
- Has chronic liver disease with severe hepatic impairment and/or cirrhosis (eg, hepatic encephalopathy)
- Anticipation of more than 1 valve replacement or repair (mechanical or biomechanical) and/or have undergone more than 1 valve replacement or repair
- Has severe tricuspid regurgitation due to primary valvular disease (eg, from endocarditis, carcinoid, or mechanical destruction)
See the full eligibility criteria
- Completed MK-7962-007 (CADENCE) (Visit 9 and EOT visit) without discontinuing study intervention and is able to safely enroll into MK-7962-007 (HARMONIZE)
- Has a diagnosis of pulmonary hypertension (PH) in world health organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5
- Has had a study intervention interruption
- Is pregnant or breastfeeding
- Has chronic liver disease with severe hepatic impairment and/or cirrhosis (eg, hepatic encephalopathy)
- Anticipation of more than 1 valve replacement or repair (mechanical or biomechanical) and/or have undergone more than 1 valve replacement or repair
- Has severe tricuspid regurgitation due to primary valvular disease (eg, from endocarditis, carcinoid, or mechanical destruction)
- Anticipated or undergone heart transplant or ventricular assist device implantation
- Has had prior exposure to luspatercept
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Israel
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Israel; United States. 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 EU CTIS; the study team decides eligibility.