An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)

Status: Recruiting
Location: See all (41) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Researchers are looking for more ways to treat PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow. This causes high blood pressure in the lungs and overworks the heart. PAH can make it hard to breathe and be active. Some standard (usual) treatments for PAH can treat symptoms of PAH but do not stop PAH from getting worse. Sotatercept is a study medicine designed to treat PAH. It is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH. This is a long-term follow-up (LTFU) study. People who took part in certain other studies testing sotatercept for PAH may be able to join this study. The goal of this study is to learn about the long-term safety of sotatercept and if people tolerate it when taken with standard PAH treatment over a longer period of time.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ The main inclusion criteria include but are not limited to the following:

• Has completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early

• Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements

• Must have the ability to understand and provide documented informed consent

Locations
United States
Arizona
Pulmonary Associates, PA ( Site 1008)
RECRUITING
Phoenix
California
University of California San Diego Health ( Site 1002)
RECRUITING
La Jolla
UCSF Helen Diller Medical Center at Parnassus Heights ( Site 1019)
RECRUITING
San Francisco
Jeffrey S. Sager, MD Medical Corporation ( Site 1060)
RECRUITING
Santa Barbara
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028)
RECRUITING
Torrance
Colorado
University of Colorado Hospital ( Site 1013)
RECRUITING
Aurora
Florida
Mayo Clinic Jacksonville ( Site 1045)
RECRUITING
Jacksonville
Kansas
University of Kansas Medical Center ( Site 1020)
RECRUITING
Kansas City
Kentucky
Norton Pulmonary Specialists ( Site 1066)
RECRUITING
Louisville
Massachusetts
Tufts Medical Center ( Site 1012)
RECRUITING
Boston
New York
Weill Cornell Medical Center ( Site 1046)
RECRUITING
New York
Ohio
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
RECRUITING
Cincinnati
University of Cincinnati Medical Center ( Site 1035)
RECRUITING
Cincinnati
Oregon
Oregon Health & Science University ( Site 1054)
RECRUITING
Portland
Other Locations
Australia
John Hunter Hospital ( Site 1101)
RECRUITING
New Lambton Heights
Denmark
Aarhus Universitetshospital, Skejby ( Site 3801)
RECRUITING
Aarhus
Rigshospitalet ( Site 3802)
RECRUITING
København Ø
France
CHU Angers ( Site 1313)
RECRUITING
Angers
Hôpital Louis Pradel ( Site 1317)
RECRUITING
Lyon
Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311)
RECRUITING
Nice
Netherlands
Amsterdam UMC, locatie VUmc ( Site 2601)
RECRUITING
Amsterdam
Radboud University Nijmegen Medical Centre ( Site 2605)
RECRUITING
Nijmegen
New Zealand
Waikato Hospital ( Site 2702)
ACTIVE_NOT_RECRUITING
Hamilton
Republic of Korea
Gachon University Gil Medical Center ( Site 3103)
ACTIVE_NOT_RECRUITING
Incheon
Samsung Medical Center ( Site 3106)
ACTIVE_NOT_RECRUITING
Seoul
Severance Hospital, Yonsei University Health System ( Site 3101)
ACTIVE_NOT_RECRUITING
Seoul
Spain
Hospital Clinic de Barcelona ( Site 1602)
RECRUITING
Barcelona
Hospital General Universitario Ramon y Cajal ( Site 1609)
RECRUITING
Madrid
Hospital Universitario 12 de Octubre ( Site 1603)
RECRUITING
Madrid
Hospital Universitario de Son Espases ( Site 1611)
RECRUITING
Palma De Mallorca
Hospital Universitario Marques de Valdecilla ( Site 1601)
RECRUITING
Santander
HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 1607)
RECRUITING
Toledo
Sweden
Sahlgrenska Universitetssjukhuset ( Site 3201)
RECRUITING
Gothenburg
Switzerland
UniversitätsSpital Zürich ( Site 3301)
RECRUITING
Zurich
Taiwan
Kaohsiung Veteran General Hospital ( Site 3702)
ACTIVE_NOT_RECRUITING
Kaohsiung City
National Cheng Kung University Hospital ( Site 3703)
ACTIVE_NOT_RECRUITING
Tainan
United Kingdom
Papworth Hospital NHS Foundation Trust ( Site 1208)
RECRUITING
Cambridge
Hammersmith Hospital ( Site 1203)
RECRUITING
London
Royal Brompton Hospital ( Site 1206)
RECRUITING
London
Freeman Hospital ( Site 1205)
ACTIVE_NOT_RECRUITING
Newcastle Upon Tyne
Royal Hallamshire Hospital ( Site 1207)
RECRUITING
Sheffield
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2021-05-12
Estimated Completion Date: 2028-12-07
Participants
Target number of participants: 815
Treatments
Experimental: Sotatercept
Participants enrolling from blinded PAH sotatercept studies will begin sotatercept at a dose of 0.3 mg/kg subcutaneous (SC) injection and can titrate up to the target dose of 0.7 mg/kg SC injection for the remainder of the study. Participants enrolling from unblinded PAH sotatercept studies will continue sotatercept at their current dose and, if at a dose \<0.7 mg/kg, can titrate up to the target dose of 0.7 mg/kg SC injection for the remainder of the study.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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