Clinical Trials in the UK / NCT06814145
Active, not recruiting
Phase 2
Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)
NCT06814145 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Hypertension, Pulmonary
Study summary
Researchers are looking for new ways to treat people with a type of pulmonary hypertension called combined postcapillary and precapillary pulmonary hypertension (Cpc-PH). This study focuses on Cpc-PH that is caused by heart failure with preserved ejection fraction (HFpEF).
Researchers want to know if the study treatment, sotatercept, can treat people with Cpc-PH caused by HFpEF. This is an extension study, which means people who took part in a certain study on sotatercept for Cpc-PH (called a parent study) may be able to join this study. In this extension study, people will take sotatercept and researchers will follow their health for a longer time.
The main goal of this extension study is to learn about the long-term safety of sotatercept and if people tolerate it over a longer period of time.
Eligibility
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
\- Completed sotatercept parent study (MK-7962-007\[CADENCE\] \[Visit 9 and EOT visit\] or MK-7962-041 \[P041\] \[EOT Visit\]) without discontinuing study intervention and is able to safely enroll into MK-7962-023 (HARMONIZE)
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* 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 and has an ongoing SAE that occurred during parent study and is suspected to be related to study intervention
* 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
Primary outcome measure(s)
- Number of Participants Who Experience an Adverse Event (AE) — Up to approximately 10 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported. - Number of Participants Who Discontinue Study Treatment Due to an AE — Up to approximately 10 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Trial sites (57)
| Facility | City | Region | Status |
|---|---|---|---|
| Pulmonary Associates, PA ( Site 1008) | Phoenix | Arizona | |
| Scripps Clinic John R Anderson V Medical Pavillion ( Site 1004) | La Jolla | California | |
| Jeffrey S. Sager, MD Medical Corporation ( Site 1060) | Santa Barbara | California | |
| Stanford University Medical Center ( Site 1024) | Stanford | California | |
| South Denver Cardiology Associates ( Site 1091) | Littleton | Colorado | |
| Yale New Haven Hospital ( Site 1093) | New Haven | Connecticut | |
| AdventHealth Orlando ( Site 1058) | Orlando | Florida | |
| The Emory Clinic ( Site 1030) | Atlanta | Georgia | |
| Norton Pulmonary Specialists ( Site 1066) | Louisville | Kentucky | |
| University Of Nebraska Medical Center ( Site 1053) | Omaha | Nebraska | |
| Weill Cornell Medical Center ( Site 1046) | New York | New York | |
| Duke University Medical Center ( Site 1026) | Durham | North Carolina | |
| The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001) | Cincinnati | Ohio | |
| The Cleveland Clinic Foundation. ( Site 1065) | Cleveland | Ohio | |
| The Ohio State University Wexner Medical Center ( Site 1032) | Columbus | Ohio | |
| Allegheny General Hospital ( Site 1088) | Pittsburgh | Pennsylvania | |
| Lankenau Medical Center ( Site 1089) | Wynnewood | Pennsylvania | |
| Rhode Island Hospital ( Site 1039) | Providence | Rhode Island | |
| Medical University of South Carolina ( Site 1003) | Charleston | South Carolina | |
| Statcare Pulmonary Consultants ( Site 1031) | Knoxville | Tennessee | |
| Intermountain Medical Center ( Site 1079) | Murray | Utah | |
| Inova Fairfax Medical Campus ( Site 1078) | Falls Church | Virginia | |
| Pulmonary Associates of Richmond - West Broad Street ( Site 1069) | Richmond | Virginia | |
| Université Libre de Bruxelles - Hôpital Erasme ( Site 0100) | Brussels | Bruxelles-Capitale, Region de | |
| Hamilton Health Sciences Hamilton General Hospital ( Site 0004) | Hamilton | Ontario | |
| Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 0206) | Nice | Alpes-Maritimes | |
| Hopital Arnaud de Villeneuve ( Site 0200) | Montpellier | Herault | |
| Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes ( Site 0205) | Saint-Herblain | Loire-Atlantique | |
| Centre Hopitalier Universitaire d'Angers ( Site 0204) | Angers | Maine-et-Loire | |
| CHU de Rouen ( Site 0203) | Rouen | Seine-Maritime | |
| Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0202) | Le Kremlin-Bicêtre | Val-de-Marne | |
| Thoraxklinik-Heidelberg gGmbH ( Site 0309) | Heidelberg | Baden-Wurttemberg | |
| Krankenhaus Neuwittelsbach ( Site 0310) | München | Bavaria | |
| UKGM Gießen/Marburg ( Site 0312) | Giessen | Hesse | |
| Universitaetsklinikum Koeln ( Site 0311) | Cologne | North Rhine-Westphalia | |
| Universitätsmedizin Johannes Gutenberg Universität Mainz ( Site 0315) | Mainz | Rhineland-Palatinate | |
| Universitaetsklinikum Carl Gustav Carus Dresden ( Site 0301) | Dresden | Saxony | |
| DRK Kliniken Berlin Westend ( Site 0307) | Berlin | Germany | |
| Rambam Health Care Campus ( Site 0403) | Haifa | Israel | |
| Edith Wolfson Medical Center ( Site 0404) | Holon | Israel |
+ 17 more sites — see the full list on the official registry below.
More Merck Sharp & Dohme LLC trials in the UK
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06814145 on ClinicalTrials.gov ↗ ← All trials in the UK