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NCT07218029Active, not recruitingPhase 3

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

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)

Source: ClinicalTrials.gov · Last updated 8 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
815 (estimated)
First submitted
7 Oct 2025
Start date
12 May 2021
Primary completion date
7 Dec 2028
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT07218029
EU CT number
2025-521970-33-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 815
  • From 12 May 2021 to the primary completion date, 7 Dec 2028
  • 137 sites in 27 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Is currently enrolled in another investigational product study other than a sotatercept study

Other

  • The main exclusion criteria include but are not limited to the following:
  • Did not participate in a sotatercept PAH parent study
  • Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.
  • Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept
  • Is a female who is pregnant or breastfeeding
  • Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study
  • Is incapacitated

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (137)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sanatorio Allende ( Site 1908)
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CórdobaArgentinaUnknown status
Instituto de Investigaciones Clinicas Quilmes ( Site 1903)
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QuilmesArgentinaUnknown status
Instituto Médico Río Cuarto ( Site 1907)
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Río CuartoArgentinaUnknown status
Sanatorio Parque ( Site 1905)
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RosarioArgentinaUnknown status
Instituto Cardiovascular de Rosario ( Site 1906)
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RosarioArgentinaUnknown status
Hospital Provincial del Centenario ( Site 1912)
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RosarioArgentinaUnknown status
Hospital Provincial Dr. Jose M. Cullen ( Site 1902)
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Santa FeArgentinaUnknown status
Royal Adelaide Hospital ( Site 1109)
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AdelaideAustraliaUnknown status
Royal Prince Alfred Hospital ( Site 1106)
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CamperdownAustraliaUnknown status
The Prince Charles Hospital ( Site 1104)
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ChermsideAustraliaUnknown status
Saint Vincents Hospital Sydney ( Site 1102)
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DarlinghurstAustraliaUnknown status
Royal Hobart Hospital ( Site 1107)
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HobartAustraliaUnknown status
Fiona Stanley Hospital ( Site 1103)
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MurdochAustraliaUnknown status
John Hunter Hospital ( Site 1101)
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New Lambton HeightsAustraliaUnknown status
Université Libre de Bruxelles - Hôpital Erasme ( Site 1402)
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BrusselsBelgiumUnknown status
UZ Leuven ( Site 1401)
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LeuvenBelgiumUnknown status
Hospital Madre Teresa ( Site 1804)
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Belo HorizonteBrazilUnknown status
Hospital Dia do Pulmao ( Site 1802)
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BlumenauBrazilUnknown status
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 1805)
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Porto AlegreBrazilUnknown status
Hospital Sao Paulo ( Site 1806)
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São PauloBrazilUnknown status
Instituto do Coracao - HCFMUSP ( Site 1803)
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São PauloBrazilUnknown status
Peter Lougheed Centre ( Site 2102)
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CalgaryCanadaUnknown status
University of Alberta Hospital ( Site 2101)
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EdmontonCanadaUnknown status
St. Joseph's Healthcare Hamilton ( Site 2105)
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HamiltonCanadaUnknown status
UniversitätsSpital Zürich ( Site 3301)
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ZurichSwitzerlandUnknown status
Fundación Neumológica Colombiana ( Site 3403)
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BogotáColombiaUnknown status
Clínica Imbanaco S.A.S ( Site 3404)
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CaliColombiaUnknown status
Institut Klinicke a Experimentalni Mediciny ( Site 2202)
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PragueCzechiaUnknown status
Vseobecna fakultni nemocnice v Praze ( Site 2201)
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PragueCzechiaUnknown status
DRK Kliniken Berlin Westend ( Site 1507)
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BerlinGermanyUnknown status
Universitaetsklinikum Koeln ( Site 1511)
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CologneGermanyUnknown status
Universitaetsklinikum Carl Gustav Carus ( Site 1501)
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DresdenGermanyUnknown status
UKGM Gießen/Marburg ( Site 1512)
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GiessenGermanyUnknown status
Universitätsklinikum Halle ( Site 1502)
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HalleGermanyUnknown status
Medizinische Hochschule Hannover ( Site 1505)
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HanoverGermanyUnknown status
Thoraxklinik-Heidelberg gGmbH ( Site 1509)
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HeidelbergGermanyUnknown status
Universitätsklinikum Leipzig ( Site 1508)
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LeipzigGermanyUnknown status
Krankenhaus Neuwittelsbach ( Site 1510)
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MunichGermanyUnknown status
Universitaetsklinik Regensburg ( Site 1503)
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RegensburgGermanyUnknown status
Aarhus Universitetshospital, Skejby ( Site 3801)
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AarhusDenmarkUnknown status
Rigshospitalet ( Site 3802)
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København ØDenmarkUnknown status
Hospital Universitari Vall D Hebron ( Site 1605)
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BarcelonaSpainUnknown status
Hospital Clinic de Barcelona ( Site 1602)
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BarcelonaSpainUnknown status
Hospital Universitario 12 de Octubre ( Site 1603)
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MadridSpainUnknown status
Hospital General Universitario Ramon y Cajal ( Site 1609)
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MadridSpainUnknown status
Hospital Universitario La Paz ( Site 1610)
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MadridSpainUnknown status
Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1604)
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MajadahondaSpainUnknown status
Hospital Universitario de Son Espases ( Site 1611)
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Palma de MallorcaSpainUnknown status
Hospital Universitario Marques de Valdecilla ( Site 1601)
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SantanderSpainUnknown status
HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 1607)
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ToledoSpainUnknown status
CHU Angers ( Site 1313)
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AngersFranceUnknown status
Hopital Cavale Blanche ( Site 1314)
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BrestFranceUnknown status
CHU de Grenoble Hopital Nord ( Site 1303)
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La TroncheFranceUnknown status
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre-Pneumologie ( Site 1304)
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Le Kremlin-BicêtreFranceUnknown status
Institut Coeur Poumon - CHRU de Lille ( Site 1306)
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LilleFranceUnknown status
Hôpital Louis Pradel ( Site 1317)
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LyonFranceUnknown status
Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311)
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NiceFranceUnknown status
CHU Bordeaux Haut-Leveque ( Site 1312)
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PessacFranceUnknown status
CHU de la Miletrie Poitiers ( Site 1316)
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PoitiersFranceUnknown status
Centre Hospitalier Universitaire de Saint Étienne- Hôpital Nord-Medecine Vasculaire et Therapeutique ( Site 1302)
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Saint-Étienne-de-MontlucFranceUnknown status
Hopital Nord Laennec ( Site 1309)
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Saint-HerblainFranceUnknown status
Nouvel Hôpital Civil (NHC) ( Site 1307)
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StrasbourgFranceUnknown status
Hopital Larrey ( Site 1315)
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ToulouseFranceUnknown status
Papworth Hospital NHS Foundation Trust ( Site 1208)
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CambridgeUnited KingdomUnknown status
Golden Jubilee National Hospital ( Site 1204)
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GlasgowUnited KingdomUnknown status
Royal Brompton Hospital ( Site 1206)
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LondonUnited KingdomUnknown status
Hammersmith Hospital ( Site 1203)
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LondonUnited KingdomUnknown status
Royal Free Hospital ( Site 1202)
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LondonUnited KingdomUnknown status
Freeman Hospital ( Site 1205)
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Newcastle upon TyneUnited KingdomUnknown status
Royal Hallamshire Hospital ( Site 1207)
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SheffieldUnited KingdomUnknown status
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 3604)
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AthensGreeceUnknown status
Onassis Cardiac Surgery Center ( Site 3602)
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AthensGreeceUnknown status
AHEPA University General Hospital of Thessaloniki-1st Cardiology Clinic ( Site 3601)
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ThessalonikiGreeceUnknown status
Klinicki Bolnicki Centar Split ( Site 3901)
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SplitCroatiaUnknown status
Carmel Hospital ( Site 1705)
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HaifaIsraelUnknown status
Haddasah Medical Center ( Site 1711)
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JerusalemIsraelUnknown status
Meir Medical Center. ( Site 1707)
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Kfar SabaIsraelUnknown status
Rabin Medical Center ( Site 1703)
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Petah TikvaIsraelUnknown status
Sheba Medical Center ( Site 1701)
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Ramat GanIsraelUnknown status
Ospedale San Giuseppe ( Site 2403)
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MilanItalyUnknown status
Fondazione IRCCS San Gerardo dei Tintori ( Site 2406)
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MonzaItalyUnknown status
A.O.R.N. Ospedale dei Colli - Monaldi V. ( Site 2407)
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NaplesItalyUnknown status
AOU Policlinico Umberto I ( Site 2402)
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RomeItalyUnknown status
Gachon University Gil Medical Center ( Site 3103)
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IncheonSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System ( Site 3101)
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SeoulSouth KoreaUnknown status
Samsung Medical Center ( Site 3106)
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SeoulSouth KoreaUnknown status
Instituto Nacional de Cardiologia Ignacio Chavez ( Site 2503)
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Mexico CityMexicoUnknown status
Unidad de Investigacion Clinica en Medicina, S.C. ( Site 2505)
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MonterreyMexicoUnknown status
Amsterdam UMC, locatie VUmc ( Site 2601)
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AmsterdamNetherlandsUnknown status
Radboud University Nijmegen Medical Centre ( Site 2605)
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NijmegenNetherlandsUnknown status
Waikato Hospital ( Site 2702)
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HamiltonNew ZealandUnknown status
Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2801)
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KrakowPolandUnknown status
Europejskie Centrum Zdrowia Otwock ( Site 2802)
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OtwockPolandUnknown status
Hospital Garcia de Orta ( Site 3501)
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AlmadaPortugalUnknown status
Hospital Pulido Valente ( Site 3503)
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LisbonPortugalUnknown status
University Clinical Hospital Center of Serbia ( Site 2901)
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BelgradeSerbiaUnknown status
Institute for Cardiovascular Diseases Dedinje ( Site 2903)
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BelgradeSerbiaUnknown status
Institute for pulmonary diseases of Vojvodina ( Site 2906)
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Novi SadSerbiaUnknown status
Sahlgrenska Universitetssjukhuset ( Site 3201)
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GothenburgSwedenUnknown status
Kaohsiung Veteran General Hospital ( Site 3702)
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Kaohsiung CityTaiwanUnknown status
National Cheng Kung University Hospital ( Site 3703)
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TainanTaiwanUnknown status
The Emory Clinic ( Site 1030)
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AtlantaUnited StatesUnknown status
University of Colorado Hospital ( Site 1013)
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AuroraUnited StatesUnknown status
Johns Hopkins University ( Site 1036)
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BaltimoreUnited StatesUnknown status
Brigham and Women's Hospital ( Site 1014)
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BostonUnited StatesUnknown status
Tufts Medical Center ( Site 1012)
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BostonUnited StatesUnknown status
Medical University of South Carolina ( Site 1003)
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CharlestonUnited StatesUnknown status
University of Cincinnati Medical Center ( Site 1035)
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CincinnatiUnited StatesUnknown status
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
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CincinnatiUnited StatesUnknown status
Cleveland Clinic Main ( Site 1065)
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ClevelandUnited StatesUnknown status
Ohio State University Wexner Medical Center ( Site 1032)
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ColumbusUnited StatesUnknown status
University of Texas Southwestern Medical Center ( Site 1038)
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DallasUnited StatesUnknown status
Duke University Medical Center ( Site 1026)
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DurhamUnited StatesUnknown status
CHI St. Luke's Health Baylor College of Medicine Medical Center ( Site 1044)
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HoustonUnited StatesUnknown status
Houston Methodist Hospital ( Site 1009)
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HoustonUnited StatesUnknown status
Mayo Clinic Jacksonville ( Site 1045)
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JacksonvilleUnited StatesUnknown status
University of Kansas Medical Center ( Site 1020)
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Kansas CityUnited StatesUnknown status
University of California San Diego Health ( Site 1002)
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La JollaUnited StatesUnknown status
Norton Pulmonary Specialists ( Site 1066)
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LouisvilleUnited StatesUnknown status
Froedtert Hospital & the Medical College of Wisconsin ( Site 1051)
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MilwaukeeUnited StatesUnknown status
University of Minnesota ( Site 1062)
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MinneapolisUnited StatesUnknown status
Weill Cornell Medical Center ( Site 1046)
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New YorkUnited StatesUnknown status
University Of Nebraska Medical Center ( Site 1053)
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OmahaUnited StatesUnknown status
UC Irvine Health Medical Center ( Site 1086)
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OrangeUnited StatesUnknown status
AdventHealth Orlando ( Site 1058)
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OrlandoUnited StatesUnknown status
Pulmonary Associates, PA ( Site 1008)
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PhoenixUnited StatesUnknown status
University of Pittsburgh Medical Center - Presbyterian Hosp. ( Site 1059)
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PittsburghUnited StatesUnknown status
Oregon Health Science University ( Site 1054)
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PortlandUnited StatesUnknown status
Rhode Island Hospital ( Site 1033)
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ProvidenceUnited StatesUnknown status
UC Davis - Medial Center ( Site 1064)
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SacramentoUnited StatesUnknown status
UCSF Helen Diller Medical Center at Parnassus Heights ( Site 1019)
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San FranciscoUnited StatesUnknown status
Jeffrey S. Sager, MD Medical Corporation ( Site 1060)
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Santa BarbaraUnited StatesUnknown status
Arizona Pulmonary Specialists ( Site 1010)
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ScottsdaleUnited StatesUnknown status
Tampa General Hospital ( Site 1043)
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TampaUnited StatesUnknown status
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028)
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TorranceUnited StatesUnknown status
University of Arizona ( Site 1006)
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TucsonUnited StatesUnknown status
George Washington University Medical Faculty Associates ( Site 1025)
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Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.