Table of Contents
- Trial overview
- Conditions being studied
- Who can take part
- Trial phases and study design
- Main outcomes measured
- Selected trial details
Trial overview
The trial data show several studies of Human Plasma Protein in different clinical settings, including surgery, sepsis, and chronic disease care.[1][2][3] Most studies are interventional, which means researchers assign a treatment and then measure what happens.[1][2]
The studies range from small trials with 47 or 60 participants to a large sepsis trial with 2000 participants.[2][4] The phases are mainly Phase 2 and Phase 3, showing that the research is testing both early effectiveness and later confirmation in larger groups.[1][2]
Conditions being studied
One trial studied adults with post-COVID-19 Postural Orthostatic Tachycardia Syndrome, also called post-COVID POTS, and compared IgPro20 with placebo.[1] The main goal was to see whether participants no longer met the diagnostic criteria for post-COVID POTS on a standing test.[1]
Another large trial, PALETTE, studied sepsis in children and adults and looked at personalized treatment choices across several study arms.[2] Sepsis is a severe body-wide response to infection that can lead to organ failure and need for life support.[2]
Other studies focused on neuromuscular scoliosis and adolescent idiopathic scoliosis during spinal fusion surgery, early symptomatic Alzheimer’s disease, and coagulation in pediatric congenital heart surgery.[3][4][5] One trial also studied heart failure with preserved ejection fraction, with or without metabolic dysfunction associated steatotic liver disease (MASLD).[6]
A separate Phase 3 study involved people with hemophilia A or hemophilia B, including those with or without inhibitory antibodies to factor VIII or IX.[7] These are bleeding disorders where the blood does not clot normally.[7]
Who can take part
The target groups are different in each study, but the overall trial set includes adults, children, and adolescents.[1][2][3][5] Some studies focus on people already receiving hospital care, such as those having sepsis treatment or surgery, while others focus on outpatients with ongoing conditions like post-COVID POTS or early Alzheimer’s disease.[1][2][4]
The trial data do not give full inclusion and exclusion rules, but they do show the intended patient groups and the main disease area for each study.[1][2][3][4][5][6][7]
Trial phases and study design
Most of the studies are in Phase 2 or Phase 3, which are common stages for testing whether a treatment may help and whether it can be studied safely in more people.[1][2][3][4][5][6][7] The post-COVID POTS study was double-blind, randomized, and placebo-controlled, which means neither the patient nor the study team knew who received the study treatment, people were assigned by chance, and a placebo was used for comparison.[1]
The scoliosis surgery study was also double-blind and randomized, while the ExPlas study and the heart surgery coagulation study were interventional trials comparing plasma-related products with other fluids or plasma types.[3][4][5] The PALETTE study was designed to generate exploratory estimates, meaning it aims to learn which treatments may look promising before confirmatory studies are done.[2]
Main outcomes measured
The studies measure different primary outcomes, which are the main results researchers want to track.[1][2][3][4][5][7] In the post-COVID POTS trial, the main outcome was the proportion of participants who no longer met the diagnostic criteria on a standardized standing test.[1]
In the sepsis trial, the dual primary endpoints were 28-day all-cause mortality and the number of days alive without life-supportive therapies at day 28.[2] Life-supportive therapies included respiratory support, cardiovascular support, and renal support, which means help for breathing, circulation, or kidney function.[2]
The scoliosis surgery study measured intraoperative blood loss, while the pediatric heart surgery study measured differences in coagulation variables after surgery, including protein C activity, protein S activity, fibrinogen, PT, aPTT, and ROTEM results.[3][5] The ExPlas study measured safety, tolerability, and feasibility through adverse events and protocol compliance after 1 year.[4]
The hemophilia study measured treatment-emergent adverse events, which are side effects or medical problems that appear after treatment starts.[7] The heart failure study focused on change in VO2max, a measure of physical fitness and how much oxygen the body can use during exercise.[6]
Selected trial details
NCT06524739 was a Phase 3 completed study in 177 adults with post-COVID POTS, and it compared IgPro20 with placebo to see whether symptoms improved enough that participants no longer met the diagnosis.[1]
2025-521371-31-00 is an authorised Phase 2 sepsis trial with 2000 participants, studying several treatment options and measuring survival and time without life-support at 28 days.[2]
2024-514857-31-00 is an authorised Phase 2 double-blind randomized trial in 90 children undergoing spinal fusion for scoliosis, with blood loss as the main outcome.[3]
NCT05068830 is an authorised Phase 2 study in 60 people with early symptomatic Alzheimer’s disease, focused on safety, tolerability, and feasibility after 1 year.[4]
2024-514073-22-01 is an authorised Phase 3 study in 120 pediatric cardiac surgery patients, comparing fresh frozen plasma and Omniplasma by looking at clotting-related measures after surgery.[5]
2025-521835-35-00 is an authorised Phase 2 study in 47 patients with HFpEF, with or without MASLD, and it measures change in VO2max during continuous subcutaneous glucagon administration.[6]
2023-508884-59-00 was a completed Phase 3 study in 281 people with hemophilia A or B, focused on long-term safety and the number of treatment-emergent adverse events.[7]
