Long-term Study of Sotatercept for Adults with Pulmonary Arterial Hypertension (PAH)

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for Pulmonary Arterial Hypertension (PAH), a condition where the blood pressure in the arteries of the lungs is higher than normal. The treatment being studied is called sotatercept, which is also known by its code name MK-7962. Sotatercept is a solution for injection and is being tested to see how safe and tolerable it is when used alongside existing PAH therapies.

The purpose of this study is to evaluate the long-term safety and tolerability of sotatercept in adults with PAH. Participants in the study will receive sotatercept through an injection under the skin. The study will follow participants over a period to monitor their health and any side effects they may experience. This is an open-label study, meaning that both the researchers and participants know what treatment is being administered.

Throughout the study, participants will have regular check-ups to assess their health, including tests like blood work and heart monitoring. The study aims to gather information on how well sotatercept works in the long term and its impact on the participants’ overall health and quality of life. This information will help determine the potential benefits and risks of using sotatercept as a treatment for PAH.

1 joining the study

Upon joining the study, participants must have completed their previous PAH sotatercept clinical study and met all requirements without early discontinuation.

Participants must agree to follow the study visit schedule and comply with all protocol requirements.

2 initial assessment

An initial assessment will be conducted to ensure eligibility, including a review of medical history and current health status.

Females of childbearing potential will undergo a pregnancy test before starting the study drug.

3 medication administration

The study involves the administration of sotatercept, a solution for injection given subcutaneously.

Participants will receive the medication as part of their ongoing treatment for pulmonary arterial hypertension (PAH).

4 ongoing monitoring

Participants will be monitored for adverse events, anti-drug antibodies, and undergo clinical laboratory assessments including blood tests and urinalysis.

Vital signs and a 12-lead electrocardiogram (ECG) will be regularly checked.

5 secondary assessments

Secondary assessments will include measuring the 6-minute walk distance, evaluating the N-terminal pro-hormone B-type natriuretic peptide levels, and assessing the World Health Organization (WHO) functional class.

Pulmonary vascular resistance and overall survival will also be evaluated, along with the Simplified French Risk score.

6 completion of study

The study is estimated to conclude by June 28, 2028.

Participants must refrain from participating in other investigational drug or device trials during this study.

Who Can Join the Study?

  • Participants must have completed their current Pulmonary Arterial Hypertension (PAH) sotatercept clinical study and must not have left the study early.
  • Participants must be willing to follow the study visit schedule and understand and comply with all study requirements.
  • Participants must be able to understand and provide written consent to participate in the study.
  • Females of childbearing potential must:
    • Have a negative pregnancy test before starting the study medication and agree to ongoing pregnancy testing during the study and for 8 weeks after the last dose.
    • If sexually active, use highly effective birth control along with a barrier method for at least 28 days before starting the study medication, during the study, and for 16 weeks after stopping the medication.
    • Refrain from breastfeeding, donating blood, eggs, or ovum during the study and for 16 weeks after the last dose.
  • Male participants must:
    • Agree to use a condom during sexual contact with a pregnant female or a female who can become pregnant while in the study, during breaks in medication, and for 16 weeks after stopping the medication, even if they have had a vasectomy.
    • Refrain from donating blood or sperm during the study and for 16 weeks after the last dose.
  • Participants must agree not to join any other trials of experimental drugs or devices while enrolled in this study.

Who Cannot Join the Study?

  • Patients who have a different condition than Pulmonary Arterial Hypertension (PAH) cannot participate.
  • Patients who are not adults are excluded from the study.
  • Patients who are not already receiving treatment for PAH cannot join the study.
  • Patients who are unable to follow the study procedures or attend follow-up visits are not eligible.
  • Patients with any other medical condition that might interfere with the study results are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients with a history of allergic reactions to the study medication are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Europejskie Centrum Zdrowia Otwock Sp. z o.o. Otwock Poland
Onassis Cardiac Surgery Center Kallithea Greece
Multimedica S.p.A. Milan Italy
Universitaetsklinikum Regensburg AöR Regensburg Germany
Hospital Clinic De Barcelona Barcelona Spain
Saarland University Hospital Homburg Germany
Centre Hospitalier Universitaire De Montpellier Montpellier France
Justus-Liebig-Universitaet Giessen Giessen Germany
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Rigshospitalet Copenhagen Denmark
KBC Split Split Croatia
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Centre Hospitalier Universitaire De Nice Nice France
Servei De Salut De Les Illes Balears Palma Spain
Stichting Radboud University Medical Center Nijmegen The Netherlands
Centre Hospitalier Universitaire De Nantes Nantes France
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Krankenhaus Neuwittelsbach Munich Germany
Osicveiwicojqq Lopi Gshu Linz Austria
Iqnhyqzta Fgs Cndgyjkl Abw Eyonhnjfszhe Mhiqazgy Prague Czechia
Hliujaav Ulvyxmfoakxct Mzegwnh Ds Vknsvlpdzc Santander Spain
Atllapkwn Uiq Amsterdam The Netherlands
Uonhfndtuz Dwktw Svwsc Dz Rkmg Lm Szzeiirh Rome Italy
Mzrzykbtjyfqmfpzwuxjawrtsq Hnnixgwxnrboquiy Halle (Saale) Germany
Cjxyht Huoxcdqpetw Rzbvfjrf Dcwzsfhqffnrod Angers France
Fsgxpsksl Pvpu Lf Icjfcleqngwoz Bygqwxwpp Dhp Hpwneraq Upjewbmxbdowq Lh Pkh Madrid Spain
Ubxfysngei Hozlboai Cgftcyp Cologne Germany
Ejnumkw Uizzeakqwfip Mneqbql Cyutlnl Rnhkbarst (jxwpass Mkl Rotterdam The Netherlands
Akjjjb Ufknjmaqad Hewpqjzg Aarhus Denmark
Ijfyhtib dh Cckgbnmcsnsa Hdrsvywryat Ummooawrslrfe dd Sueus Ehvyqqh (tifoyrv Saint Priest En Jarez France
Hapharwa Vpii daukzqfy Barcelona Spain
Kwmmgveir Stpgyap Srqrgxyaatsytxx ig Jslc Peipi Ip Cracow Poland
Hzhlivkg Unnamybllllaqs Suwdevvrje &jienep Hbejgyk dq Hjcfziyfpvu STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
30.04.2021
Belgium Belgium
Not recruiting
30.04.2021
Croatia Croatia
Not recruiting
30.04.2021
Czechia Czechia
Not recruiting
30.04.2021
Denmark Denmark
Not recruiting
30.04.2021
France France
Not recruiting
30.04.2021
Germany Germany
Not recruiting
30.04.2021
Greece Greece
Not recruiting
30.04.2021
Italy Italy
Not recruiting
30.04.2021
Poland Poland
Not recruiting
30.04.2021
Portugal Portugal
Not recruiting
30.04.2021
Spain Spain
Not recruiting
30.04.2021
Sweden Sweden
Not recruiting
30.04.2021
The Netherlands The Netherlands
Not recruiting
30.04.2021

Trial locations

Investigated drugs:

Sotatercept is a medication being studied for its potential to help treat pulmonary arterial hypertension (PAH). It is being tested to see how safe and tolerable it is for long-term use when added to other PAH treatments. This medication works by targeting specific pathways in the body that are involved in the development of PAH, with the aim of improving symptoms and outcomes for patients with this condition.

Investigated diseases:

Pulmonary Arterial Hypertension (PAH) – Pulmonary Arterial Hypertension is a condition characterized by high blood pressure in the arteries that supply the lungs. This increased pressure makes it difficult for the heart to pump blood through the lungs, leading to symptoms such as shortness of breath, fatigue, and chest pain. Over time, the heart may become enlarged and weakened due to the increased workload. The disease progresses as the blood vessels in the lungs become more narrowed or blocked, further increasing the pressure. This can lead to complications such as heart failure if not managed. PAH is considered a rare disease and can significantly impact a person’s quality of life.

Trial ID:
2023-509138-21-00
Protocol code:
A011-12
NCT ID:
NCT04796337
Trial Phase:
Therapeutic confirmatory (Phase III)

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