In short
Clinical trials investigating Human Plasma Protein are studying how plasma protein products are used in different patient groups. These studies look at safety, efficacy, and practical use in conditions such as sepsis, scoliosis surgery, Alzheimer’s disease, congenital heart surgery, and post-COVID POTS.
Key points
- Clinical trials investigating Human Plasma Protein are being done in several different patient groups, including adults and children. The studies focus on conditions such as sepsis, scoliosis surgery, early Alzheimer’s disease, pediatric heart surgery, post-COVID POTS, heart failure with preserved ejection fraction, and hemophilia. Most of the trials are Phase 2 or Phase 3, which means they are checking early benefit, safety, and larger-scale confirmation. The main outcomes include blood loss, clotting measures, mortality, life-support needs, adverse events, and whether symptoms or diagnostic criteria improve. Enrollment ranges from small studies with fewer than 50 people to large studies with 2000 participants. Overall, the trial data show that Human Plasma Protein is being studied in both urgent hospital settings and longer-term disease management.
Trial overview
The trial data show several studies of Human Plasma Protein in different clinical settings, including surgery, sepsis, and chronic disease care. Most studies are interventional, which means researchers assign a treatment and then measure what happens.
The studies range from small trials with 47 or 60 participants to a large sepsis trial with 2000 participants. The phases are mainly Phase 2 and Phase 3, showing that the research is testing both early effectiveness and later confirmation in larger groups.
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. The main goal was to see whether participants no longer met the diagnostic criteria for post-COVID POTS on a standing test.
Another large trial, PALETTE, studied sepsis in children and adults and looked at personalized treatment choices across several study arms. Sepsis is a severe body-wide response to infection that can lead to organ failure and need for life support.
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. One trial also studied heart failure with preserved ejection fraction, with or without metabolic dysfunction associated steatotic liver disease (MASLD).
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. These are bleeding disorders where the blood does not clot normally.
Who can take part
The target groups are different in each study, but the overall trial set includes adults, children, and adolescents. 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.
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.
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. 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.
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. The PALETTE study was designed to generate exploratory estimates, meaning it aims to learn which treatments may look promising before confirmatory studies are done.
Main outcomes measured
The studies measure different primary outcomes, which are the main results researchers want to track. 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.
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. Life-supportive therapies included respiratory support, cardiovascular support, and renal support, which means help for breathing, circulation, or kidney function.
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. The ExPlas study measured safety, tolerability, and feasibility through adverse events and protocol compliance after 1 year.
The hemophilia study measured treatment-emergent adverse events, which are side effects or medical problems that appear after treatment starts. The heart failure study focused on change in VO2max, a measure of physical fitness and how much oxygen the body can use during exercise.
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.
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.
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.
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.
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.
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.
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.