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A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
Sponsor: Tectonic Therapeutic
Summary
TX000045-003 is a double-blind, randomized, parallel group, placebo-controlled, proof- of-concept (POC) study, evaluating 2 dose regimens of TX000045 over the course of a 24-week treatment period (the APEX study).
Official title: A Phase 2, Double-blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of TX000045 After 24 Weeks of Treatment in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (PH-HFpEF)
Key Details
Gender
All
Age Range
18 Years - 83 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2024-09-04
Completion Date
2026-11-20
Last Updated
2026-03-27
Healthy Volunteers
No
Interventions
TX000045- Dose A
The participants will receive a subcutaneous injection of Dose A of TX000045 every 2 weeks for 24 weeks.
TX000045- Dose B
The participants will receive subcutaneous injection of Dose B of TX000045 every 4 weeks for 24 weeks where they will alternate between TX000045 and placebo every 2 weeks.
Placebo
The participants will receive a subcutaneous injection of placebo every 2 weeks for 24 weeks.
Locations (86)
Phoenix
Phoenix, Arizona, United States
Scottsdale
Scottsdale, Arizona, United States
San Francisco
San Francisco, California, United States
Santa Rosa
Santa Rosa, California, United States
Aurora
Aurora, Colorado, United States
Jacksonville
Jacksonville, Florida, United States
Tampa
Tampa, Florida, United States
Augusta
Augusta, Georgia, United States
McDonough
McDonough, Georgia, United States
Boise
Boise, Idaho, United States
Chicago
Chicago, Illinois, United States
Indianapolis
Indianapolis, Indiana, United States
USA
Louisville, Kentucky, United States
Baltimore
Baltimore, Maryland, United States
Boston
Boston, Massachusetts, United States
Minneapolis
Minneapolis, Minnesota, United States
St Louis
St Louis, Missouri, United States
Omaha
Omaha, Nebraska, United States
New York
New York, New York, United States
New York
New York, New York, United States
Durham
Durham, North Carolina, United States
Toledo
Toledo, Ohio, United States
Philadelphia
Philadelphia, Pennsylvania, United States
Pittsburgh
Pittsburgh, Pennsylvania, United States
York
York, Pennsylvania, United States
Rock Hill
Rock Hill, South Carolina, United States
Port Arthur
Port Arthur, Texas, United States
Waco
Waco, Texas, United States
Salt Lake City
Salt Lake City, Utah, United States
United States
Norfolk, Virginia, United States
Richmond
Richmond, Virginia, United States
Yerevan
Yerevan, Armenia
Yerevan
Yerevan, Armenia
Yerevan
Yerevan, Armenia
Camperdown
Camperdown, New South Wales, Australia
Macquarie
Macquarie, New South Wales, Australia
New Lambton
New Lambton, New South Wales, Australia
Sydney
Sydney, New South Wales, Australia
Wollongong
Wollongong, New South Wales, Australia
Auchenflower
Auchenflower, Queensland, Australia
Chermside
Chermside, Queensland, Australia
Hobart
Hobart, Tasmania, Australia
Malvern
Malvern, Victoria, Australia
Camperdown
Camperdown, Australia
New Lambton
New Lambton, Australia
Austria
Vienna, Austria
Brussel
Brussels, Belgium
Genk
Genk, Belgium
Pleven
Pleven, Bulgaria
Plovdiv
Plovdiv, Bulgaria
Sofia
Sofia, Bulgaria
Sofia
Sofia, Bulgaria
Tbilisi
Tbilisi, Tb, Georgia
Tbilisi
Tbilisi, Georgia
Tbilisi
Tbilisi, Georgia
Tbilisi
Tbilisi, Georgia
Mainz
Mainz, Germany
Riga
Riga, Latvia
Chisinau
Chisinau, Moldova
Christchurch
Christchurch, New Zealand
Dunedin
Dunedin, New Zealand
Białystok
Bialystok, Poland
Krakow
Krakow, Poland
Łodź
Lodz, Poland
Lublin
Lublin, Poland
Warsaw
Warsaw, Poland
Wrocław
Wroclaw, Poland
Almada
Almada, Portugal
Lisboa
Lisbon, Portugal
Porto
Porto, Portugal
Bucuresti
Bucharest, Romania
Craiova
Craiova, Romania
Targu Mures
Târgu Mureş, Romania
Nis, Belgrade
Belgrade, Nis, Serbia
Belgrade
Belgrade, Serbia
Serbia
Belgrade, Serbia
Sremska Kamenica
Kamenitz, Serbia
Kragujevac
Kragujevac, Serbia
Barcelona
Barcelona, Spain
Madrid
Madrid, Spain
Madrid
Madrid, Spain
Santiago de Compostela ( Coruña )
Santiago de Compostela, Spain
Toledo
Toledo, Spain
Valencia
Valencia, Spain
Valencia
Valencia, Spain
Ukraine
Kyiv, Ukraine