Table of Contents
- Clinical trials overview
- Septic shock study
- Subclinical heart failure study
- Systemic scleroderma study
- What the trials measure
- Who may participate
- Trial phases and study size
Clinical trials overview
The source data includes three authorised interventional studies that investigate Albumin as part of a treatment plan in different diseases.[1][2][3] These studies are in Phase 2 or Phase 3 and focus on patient groups with serious or ongoing health problems.[1][2][3]
Septic shock study
NCT02883803 is a Phase 2 randomized comparator-controlled study in hospitalised intensive care patients with very severe community-acquired septic shock and at least two non-haemodynamic organ failures for less than 12 hours.[1] The study includes Albumin 40 g/L as one of the listed interventions, together with mesenchymal stem cells and sodium chloride.[1]
The main goal is to see whether early treatment changes the evolution of organ failure, using the SOFA score at day 7, or earlier if the patient dies or leaves intensive care before day 7.[1] The SOFA score is a clinical score that tracks how badly organs are failing.[1]
Subclinical heart failure study
The TREASURE trial, 2022-503135-33-00, is a Phase 3 interventional study in people with subclinical heart failure.[2] In this study, Albumin is listed among the interventions together with valsartan, perindopril, and nitrospray.[2]
The primary outcomes focus on signs of heart remodelling, which means changes in the shape and structure of the heart, and on heart function measures such as left ventricular mass index, concentric remodelling, ejection fraction, valve dysfunction, and signs of myocardial infarction.[2] The brief summary says the main objective is to compare an ACE inhibitor strategy with usual care over two years in women with asymptomatic heart failure, although the trial record also lists Albumin as an intervention.[2]
Systemic scleroderma study
NCT2024-518516-39-00 is a Phase 2 interventional study in patients with systemic scleroderma.[3] The intervention list includes Albumin 2.5% injection together with sodium chloride solution and CellReady.[3]
This study looks at mouth fibrosis and handicap, which means how much stiffness and disability affect the mouth and daily life.[3] The main endpoint is the change in the Mouth Handicap in Systemic Sclerosis scale, called MHISS, from baseline to week 12, and a change of at least 5 points is considered clinically significant.[3]
What the trials measure
Each study uses a different primary outcome, which is the main result the researchers want to measure.[1][2][3] In septic shock, the main outcome is the SOFA score; in heart failure, the main outcomes are heart structure and function measures; and in systemic scleroderma, the main outcome is MHISS change at week 12.[1][2][3]
These endpoints help researchers see whether the study treatment is helping the target problem in each disease group.[1][2][3]
Who may participate
The septic shock study is for intensive care patients with very severe community-acquired septic shock and recent organ failure.[1]
The heart failure study is for women with asymptomatic or subclinical heart failure.[2]
The scleroderma study is for patients with systemic scleroderma.[3]
Trial phases and study size
The source data shows two Phase 2 studies and one Phase 3 study.[1][2][3] The planned enrollment is 66 participants for the septic shock study, 130 for the heart failure study, and 50 for the scleroderma study.[1][2][3]
Phase 2 studies usually look for early signs that a treatment may help, while Phase 3 studies are later and usually include more people.[1][2][3]
