Phase
Condition
Scleroderma
Circulation Disorders
Stress
Treatment
Placebo
TX000045- Dose A
TX000045- Dose B
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Is a male or female of non-childbearing potential between the ages of 18 and 80years.
Has a diagnosis of PH-HFpEF based on baseline echocardiogram and right heartcatheterization (RHC).
Has NYHA functional class II- III heart failure.
Has 6MWT distance from 100 to 450m.
Chronic medication for heart failure or cardiovascular disease is at a stable doseprior to screening.
Is able to understand and provide documented consent for participation.
Exclusion
Exclusion Criteria:
Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5.
Current or recent hospitalization prior to screening.
Recently received vasoactive drugs, pulmonary arterial hypertension-specifictherapies, or relaxin receptor agonist.
Initiated a new exercise program for cardiopulmonary rehabilitation or plans toinitiate such a program during the study.
Has a body mass index <18 kg/meter square or >45 kg/ meter square.
Was previously administered TX000045, relaxin, or a relaxin fusion protein.
Historical or current evidence of a clinically significant disease or disorder suchas significant lung disease, cardiovascular comorbitiies, liver disease, infectiousdisease, or malignancy.
Has any of the following clinical laboratory values during screening:
Serum alanine aminotransferase or aspartate aminotransferase levels > 3 x theupper limit of normal (ULN) or total bilirubin > 3 x ULN;
eGFR <30 mL/min/1.73 metersquare;
HbA1c (glycosylated hemoglobin) >9%;
Platelet count <50,000/millimeter cube;
Hemoglobin <10.0g/dL;
History of hypersensitivity or reactions to drugs with a similar chemical structureor class to TX000045.
Is pregnant or breastfeeding.
Has a history of cancer other than basal cell carcinoma, cervical carcinoma, orsquamous cell carcinomas of the skin.
Has a history of drug or alcohol abuse.
Was recently dosed in any clinical research study.
Study Design
Study Description
Connect with a study center
Yerevan
Yerevan, 0006
ArmeniaSite Not Available
Westmead Hospital
Macquarie, New South Wales 2109
AustraliaSite Not Available
Wollongong
Wollongong, New South Wales 2500
AustraliaSite Not Available
Auchenflower
Auchenflower, Queensland 4066
AustraliaSite Not Available
Chermside
Chermside, Queensland 4032
AustraliaSite Not Available
Hobart
Hobart, Tasmania 7000
AustraliaSite Not Available
Pleven
Pleven, 5800
BulgariaSite Not Available
Plovdiv
Plovdiv, 4004
BulgariaSite Not Available
Sofia
Sofia, 1700
BulgariaSite Not Available
Tbilisi
Tbilisi, Tb 0186
GeorgiaSite Not Available
Hamburg
Hamburg, 20246
GermanySite Not Available
Mainz
Mainz, 55131
GermanySite Not Available
Remscheid
Remscheid, 42859
GermanySite Not Available
Chisinau
Chisinau,
Moldova, Republic ofActive - Recruiting
Christchurch
Christchurch, 8011
New ZealandSite Not Available
Białystok
Białystok, 15-276
PolandSite Not Available
Krakow
Kraków, 31-202
PolandSite Not Available
Lublin
Lublin, 20-090
PolandSite Not Available
Łodź
Łódź, 91-347
PolandSite Not Available
Barcelona
Barcelona, 8035
SpainSite Not Available
Madrid
Madrid, 28034
SpainSite Not Available
Santiago de Compostela ( Coruña )
Santiago De Compostela, 15706
SpainSite Not Available
Valencia
Valencia, 46010
SpainSite Not Available
Gaziantep
Gaziantep, 27310
TurkeySite Not Available
Istanbul
Istanbul, 34899
TurkeySite Not Available
Birmingham
Birmingham, Alabama 35205
United StatesSite Not Available
Aurora
Aurora, Colorado 80045
United StatesSite Not Available
Covington
Covington, Georgia 70433
United StatesSite Not Available
Boston
Boston, Massachusetts 02180
United StatesSite Not Available
Jackson
Jackson, Mississippi 39216
United StatesSite Not Available
St Louis
Saint Louis, Missouri 63110
United StatesSite Not Available
New York
New York, New York 10029
United StatesSite Not Available
Durham
Durham, North Carolina 27710
United StatesSite Not Available
Toledo
Toledo, Ohio 43606
United StatesSite Not Available
Pittsburgh
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
York
York, Pennsylvania 17403
United StatesSite Not Available
Nashville
Nashville, Tennessee 37205
United StatesSite Not Available
Beaumont
Beaumont, Texas 77702
United StatesSite Not Available
Port Arthur
Port Arthur, Texas 77642
United StatesSite Not Available
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