[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AOP Orphan Pharmaceuticals AG\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":95},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100649514","treprostinil-in-pulmonary-hypertension-evidence-and-clinical-trends-100649514",false,"NCT07736846","TREPROSTINIL in Pulmonary Hypertension: Evidence and Clinical Trends","Multicenter Registry Evaluating Real-World Therapeutic Patterns and Outcomes in Newly Diagnosed Adult Patients With Pulmonary Arterial Hypertension (PAH) Treated With Parenteral Treprostinil","Inclusion Criteria:\n\n* Adult patient (≥18 years)\n* Confirmed diagnosis of PAH (i.e. Group 1 as defined by ESC\u002FERS guidelines)\n* Initiated on parenteral Treprostinil (SC or IV) anytime from 1\u002F1\u002F2024\n* Informed consent (prospective data or retrospective chart review, per local regulations)\n\nExclusion Criteria:\n\n* Participation in any interventional trials affecting PAH (including patients from TripleTRE study)\n* Non-PAH forms of pulmonary hypertension (e.g., ESC-ERS Group 2-5)","ALL","18 Years",{"count":19,"type":20},300,"ESTIMATED","36 Months","OBSERVATIONAL","TRESPECT is an international, multicenter, observational registry designed to describe the real-world use, effectiveness, and tolerability of parenteral treprostinil in adults with newly diagnosed pulmonary arterial hypertension (PAH). The registry will include patients who initiated subcutaneous or intravenous treprostinil within 12 months of PAH diagnosis.\n\nBoth retrospective and prospective data will be collected from routine clinical care. Data will include patient characteristics, PAH treatment patterns, treprostinil dosing and route of administration, functional status, exercise capacity, biomarkers, echocardiographic and hemodynamic parameters, clinical events, and adverse events. Participants will be followed for at least 36 months or until a registry termination criterion is met. The registry is expected to enroll approximately 100 to 300 patients across specialized PAH centers in several European countries.",[25],"Pulmonary Arterial Hypertension (PAH)",[27,28,29,30,31],"Pulmonary Arterial Hypertension","Treprostinil","Parenteral Treprostinil","Subcutaneous Treprostinil","Observational Registry","NOT_YET_RECRUITING","2026-07-26",{"date":35,"type":36},"2026-07-30","ACTUAL",{"date":38,"type":20},"2026-07",{"date":40,"type":20},"2031-12",{"name":42,"class":43},"AOP Orphan Pharmaceuticals AG","INDUSTRY",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100542989","phase-3-investigational-trial-to-evaluate-safety-and-tolerability-of-treprostinil-in-children-diagnosed-with-pah-100542989","NCT06350032","Investigational Trial to Evaluate Safety and Tolerability of Treprostinil in Children Diagnosed With PAH","Open-label, Single-arm, Non-controlled Trial to Evaluate Safety and Tolerability of Treprostinil Sodium in Children Below the Age of 18 Years Diagnosed With Pulmonary Arterial Hypertension (PAH)","Inclusion Criteria:\n\n1. Signed informed consent by the parents or the legal representatives and written assent from appropriately aged participants\n2. Males or females from birth to under 18 years of age at the time informed consent was signed\n3. Confirmed diagnosis of severe PAH classified as PH Group 1 requiring a treatment with prostacyclin infusion\n4. Current diagnosis of PAH confirmed by right heart catheterisation (RHC) at screening or by historical RHC prior to screening with following haemodynamic findings:\n\n   * Mean pulmonary arterial pressure (mPAP) \\>20 mmHg\n   * Pulmonary vascular resistance Index (PVRI) \\>3 Wood Units (WU) m² If RHC is not possible due to medical reasons (e.g. neonates and infants), the confirmation by ECHO at the screening is sufficient.\n5. Prostacyclin naïve or patients pre-treated with SC or IV treprostinil prior to screening\n6. A subject is eligible to participate in this study, as assessed by the investigator, if they are of:\n\n   * Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,\n   * Child-bearing potential - has a negative pregnancy test and is not lactating and, if sexually active, agrees to continue to use 2 reliable methods of contraception until study completion and for at least 30 days following the last dose of study drug. Examples of reliable birth control methods include true abstinence as a lifestyle choice (periodic sexual abstinence method is not acceptable); the use of oral contraceptives; a reliable barrier method of birth control (diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices)\n\nExclusion Criteria:\n\n1. Known intolerance to prostacyclin analogues\n2. PH related to conditions other than specified above\n3. Unrepaired congenital heart disease if surgery is planned within next 5 months\n4. Subjects diagnosed with any lung disease\n5. Acutely decompensated heart failure within previous 30 days from screening\n6. Subjects who have had an atrial septostomy or potts shunt within the previous 6 months of screening\n7. Any clinically significant laboratory abnormality that precludes initiation or continuation of treprostinil therapy\n8. Moderate to severe hepatic dysfunction as defined by elevated liver function tests (aspartate aminotransferase or alanine aminotransferase) ≥3 times the upper limit of normal at Screening, or Child Pugh class B or C hepatic disease\n9. Subjects who are pregnant or breastfeeding\n10. Haematological abnormalities (e.g., severe anaemia, Hgb \\\u003C10 g\u002FdL, leukopenia, White Blood Cells (WBC) \\\u003C2500\u002FμL)\n11. History of substance use disorder, unless a proof of abstinence ≥1 year is provided\n12. Other concurrent severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study\n13. Participation in another clinical trial of an investigational drug or device (including with placebo) within 30 days or 5 half-lives prior to screening, which-ever is longer\n14. Patients not able to handle pumps and infusion site if there is no parent, family member, guardian present in their household taking over pump handling or if they are not treated in hospital set-up",{"count":52,"type":20},20,"INTERVENTIONAL",[55],"PHASE3","The goal of this clinical trial is to evaluate safety and tolerability of preservative-free parenteral treprostinil in paediatric patients with PAH (PH Group 1) who are below 18 years of age. The main question it aims to answer is:\n\n• if preservative-free parenteral treprostinil is safe and tolerable in the treatment of paediatric PAH in patients who are either prostacyclin-naïve or have been previously treated with commercially available parenteral treprostinil formulations.\n\nParticipants will receive either subcutaneous (SC) or intravenous (IV) preservative-free treprostinil and will be observed for 5 months (20 weeks ± 1 week).",[27],"RECRUITING","2025-05-27",{"date":61,"type":36},"2025-05-31",{"date":63,"type":36},"2024-07-31",{"date":65,"type":20},"2028-11",{"name":42,"class":43},5,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":53,"phases":79,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100540512","phase-4-initial-triple-therapy-including-parenteral-treprostinil-vs-initial-double-oral-therapy-in-pah-group-i-patients-100540512","NCT06317805","Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients","Randomized Trial Comparing Efficacy and Safety of Initial Triple Therapy Including Parenteral Treprostinil to Initial Double Oral Therapy in Pulmonary Arterial Hypertension (PAH) Group I Patients (TripleTRE)","TripleTRE","Inclusion Criteria:\n\n* Signed informed consent prior to any trial-mandated procedure\n* Male or female ≥ 18 and ≤ 70 years of age\n* Symptomatic treatment-naïve PAH patients (group I) with confirmed diagnosis of one of the following subgroups:\n\n  * idiopathic pulmonary arterial hypertension (IPAH)\n  * hereditary pulmonary arterial hypertension (HPAH)\n  * Drug and toxin-induced pulmonary arterial hypertension (DPAH)\n  * PAH associated with Connective Tissue Disease\n  * PAH with corrected congenital heart disease 4. Intermediate-high risk patients rated acc. the simplified four-strata risk-assessment tool or intermediate-low risk with severe hemodynamic impairment as defined in current PH guidelines i.e., mean right atrial pressure (RAP) ≥ 20 mmHg, cardiac index (CI) \\\u003C 2.0 L\u002Fmin, stroke volume index (SVI) \\\u003C 31 mL\u002Fm2 and\u002For pulmonary vascular resistance (PVR) ≥ 12 WU\n* Right Heart Catheterization (RHC) meeting all the following criteria:\n\n  * Mean pulmonary arterial pressure (mPAP) \\> 20 mmHg\n  * Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg\n  * PVR \\> 2 Wood Units\n* Women of childbearing potential must not be pregnant or lactating, must perform regular pregnancy tests, if sexually active, agrees to continue to use reliable method(s) of contraception until study completion\n\nExclusion Criteria:\n\n* PAH patients (group I) belonging to one of the following subgroups:\n\n  * Schistosomiasis\n  * HIV infection\n  * Portal hypertension\n  * Diffuse systemic sclerosis\n  * Uncorrected congenital heart disease including uncorrected systemic-to-pulmonary shunts\n* Any PAH-specific drug therapy in the past 3 months\n* Patients responding to vasoreactivity testing with calcium channel blockers (CCB)\n* Post-capillary PH and left heart disease\n* Known or suspected pulmonary veno-occlusive disease (PVOD)\n* Any PH due to lung disease\n* Any disorder of the respiratory system expressed by Diffusing Capacity of Lung for Carbon Monoxide (DLCO) \\\u003C40% and a noticeable imaging result (e.g., CT) and (Total Lung Capacity) TLC \\\u003C60% and (Forced Expiratory Volume) FEV1 \\\u003C70% by plethysmography (a pulmonary function test)\n* Patients with need of ambulatory or long-term oxygen therapy\n* Electrocardiogram (ECG) with Fridericia's corrected QT interval (QTcF) \\> 480 msec at screening\n* Body mass index (BMI) \\> 35 (kg\u002Fm2)\n* Age \\> 70 years\n* History of restrictive, constrictive or congestive cardiomyopathy, atrial septostomy, any symptomatic coronary disease events within 6 months, severe uncontrolled arterial hypertension, acutely decompensated heart failure and myocardial infarction within 30 days, significant (≥ 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease, chronic systemic hypotension, unstable angina pectoris, permanent\u002Fpersistent atrial fibrillation and\u002For need for pacemaker\n* Patients with acute anemia with hemoglobin (Hb) values \\\u003C11g\u002FdL\n* Cerebrovascular accident within 3 months\n* Documented severe hepatic impairment (with or without cirrhosis) according to National Cancer Institute organ dysfunction working group criteria, defined as total bilirubin \\> 3× upper limit of the normal range (ULN) accompanied by aspartate aminotransferase (AST) \\> ULN and\u002For Child-Pugh Class C\n* Documented renal insufficiency with Glomerular Filtration Rate (GFR) \\\u003C30 ml\u002Fmin\n* Patients with untreated sleep apnea\n* Patient with other cardiovascular, liver, renal, hematologic, gastrointestinal (including active gastrointestinal ulcer), immunologic, endocrine (e.g., uncontrolled diabetes), metabolic, or central nervous system disease and acute bleeding and injuries (e.g., intracranial hemorrhage) that, in the opinion of the investigator, may adversely affect the safety of the patient and \u002For efficacy of the therapy or significantly limit the lifespan (\\\u003C 12 months)\n* Patients with major surgery in the last 12 months\n* Known history of alcohol abuse\n* Treatment of a a cytochrome P450 (CYP)2C8 enzyme inducer (e.g., rifampicin) ≤ 28 days and\u002For treatment of a CYP2C8 enzyme inhibitor (e.g., gemfibrozil) ≤ 28 days\n* Treatment with another investigational drug (planned, or taken ≤ 12 weeks)\n* Hypersensitivity to any of the trial treatments or any excipient of their formulations\n* Pregnancy, breastfeeding, or intention to become pregnant during the trial\n* Any other significant disease or disorder which, in the opinion of the investigator, may put the patients at risk when participating in the trial\n* Any factor or condition likely to affect protocol compliance of the patient, as judged by the investigator.","70 Years",{"count":78,"type":20},110,[80],"PHASE4","TripleTRE investigates the effect of initial triple combination therapy (oral endothelin receptor antagonist (ERA) + oral phosphodiesterase tyüe-5 inhibitor (PDE-5i) + parenteral treprostinil) compared to double oral therapy (oral ERA + oral PDE-5i) in pulmonary arterial hypertension (PAH) patients (group I) with intermediate-high risk or patients with intermediate-low risk with severe hemodynamic impairment at baseline in a prospective, randomized, unblinded setting with scope of increasing evidence for optimization of therapy concepts in PAH.\n\nThe effect of initial triple combination therapy vs initial double oral therapy (standard of care (SoC)) will be measured by primary endpoint: (non)response to the assigned treatment.",[27],[84,85],"intermediate-high risk","intermediate-low risk with severe hemodynamic impairment","2024-03-12",{"date":88,"type":36},"2024-03-19",{"date":90,"type":36},"2023-12-06",{"date":92,"type":20},"2027-06-30",{"name":42,"class":43},19,""]