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Human Plasma Protein

Clinical trials involving Human Plasma Protein are studying different patient groups, including children and adults with sepsis, scoliosis surgery, Alzheimer’s disease, and other conditions. These studies mainly look at safety, efficacy, and practical use in real treatment settings. The trials also measure outcomes such as blood loss, clotting, survival, and ability to follow the study plan.

Table of contents

Overview of the trials

The data include several interventional studies that investigate Human Plasma Protein directly or as part of plasma products used in patient care.[1][3][4]

These studies are being done in different settings, from long-term diseases to urgent hospital care, and they focus on outcomes such as safety, blood clotting, blood loss, and survival.[1][2][4]

Conditions being studied

The trials cover a wide range of conditions, including post-COVID-19 Postural Orthostatic Tachycardia Syndrome (POTS), sepsis, scoliosis surgery in children, early symptomatic Alzheimer’s disease, pediatric cardiac surgery, heart failure with preserved ejection fraction, and hemophilia A or B.[1][2][3][4][5][6][7]

Some studies focus on emergency or hospital care, such as sepsis and surgery, while others look at chronic conditions like Alzheimer’s disease, HFpEF, and hemophilia.[2][3][4][5][6][7]

Phases and participants

The studies are mostly in Phase 2 or Phase 3, which means they are testing the treatment in patients and collecting clinical results in larger groups.[1][2][3][4][5][6][7]

The planned enrollment ranges from 47 participants in one study to 2000 in the sepsis trial, showing that some studies are small and focused while others are much larger.[2][6][1][3][4][5][7]

One study is completed, while the others in the dataset are authorised.[1][2][3][4][5][6][7]

Main outcomes being measured

The POTS study measures whether participants no longer meet the diagnostic criteria for post-COVID POTS during a standardized standing test, which checks the heart rate response when standing up.[1]

The sepsis study uses two main outcomes: 28-day all-cause mortality and the number of days alive without life-supportive therapies, such as breathing support, medicines that raise blood pressure, or kidney replacement therapy.[2]

The scoliosis surgery study measures intraoperative blood loss, meaning how much blood is lost during the operation after the wound is closed.[3]

The Alzheimer’s disease study looks at adverse events after one year and how many participants follow the research protocol, which helps judge safety, tolerability, and feasibility.[4]

The pediatric cardiac surgery study compares clotting variables after surgery, including protein C activity, protein S activity, antithrombin, plasminogen, fibrinogen, and tests such as ROTEM, aPTT, and PT.[5]

The HFpEF study measures the change in VO2max, which is the maximum amount of oxygen the body can use during exercise, after continuous subcutaneous glucagon administration.[6]

The hemophilia study focuses on the number of participants with treatment-emergent adverse events, which are side effects that appear during the study after treatment starts.[7]

Key trial details

NCT06524739 is a double-blind, randomized, placebo-controlled Phase 3 study in adults with post-COVID POTS, with 177 planned participants.[1] Its main goal is to test whether the study treatment helps more participants no longer meet the diagnostic criteria for POTS.[1]

2025-521371-31-00 is a Phase 2 sepsis trial in children and adults, with 2000 planned participants, and it is designed to generate exploratory estimates of treatment effects on mortality and life-support needs at 28 days.[2]

2024-514857-31-00 is a Phase 2 double-blind randomized trial in children undergoing instrumented spinal fusion for scoliosis, with 90 planned participants, and it compares OCTAPLAS with Plasma-Lyte for blood management.[3]

NCT05068830 is a Phase 2 study in people with early symptomatic Alzheimer’s disease, with 60 planned participants, and it looks at safety, tolerability, and feasibility over one year.[4]

2024-514073-22-01 is a Phase 3 study in pediatric congenital heart surgery, with 120 planned participants, and it compares clotting outcomes after fresh frozen plasma or Omniplasma use.[5]

2025-521835-35-00 is a Phase 2 study in patients with HFpEF, with or without MASLD, and it measures exercise capacity through VO2max after continuous glucagon administration.[6]

2023-508884-59-00 is a Phase 3 study in people with hemophilia A or B, with 281 planned participants, and it focuses on long-term safety and tolerability.[7]

What this means for patients

These trials show that research involving Human Plasma Protein is being used in very different clinical situations, not just one disease area.[1][2][3][4][5][6][7]

Across the studies, the main focus is on whether the treatment approach is safe, practical, and helpful for the target patient group.[1][2][4][7]

Because the trials use different designs and endpoints, each study answers a specific research question for its own condition.[3][5][6]

Trial ID Phase Condition studied Status Enrollment
NCT06524739 Phase 3 Post-COVID-19 POTS Completed 177
2025-521371-31-00 Phase 2 Sepsis Authorised 2000
2024-514857-31-00 Phase 2 Neuromuscular scoliosis, adolescent idiopathic scoliosis Authorised 90
NCT05068830 Phase 2 Early symptomatic phase Alzheimer’s disease Authorised 60
2024-514073-22-01 Phase 3 Coagulation in pediatric cardiac surgery Authorised 120
2025-521835-35-00 Phase 2 Heart Failure with preserved Ejection Fraction (HFpEF) with or without MASLD Authorised 47
2023-508884-59-00 Phase 3 Hemophilia A or Hemophilia B Completed 281

FAQ

  • Who can take part in clinical trials involving Human Plasma Protein? It depends on the study. The trials in the data include adults with post-COVID POTS, children and adults with sepsis, children having scoliosis surgery, and people with early symptomatic Alzheimer’s disease.
  • What are these trials trying to find out? They are checking whether Human Plasma Protein-related treatments or plasma products are safe and effective in specific conditions. Some trials also measure blood loss, clotting, survival, or whether patients can follow the study plan.
  • What trial phases are included? The trials are mostly Phase 2 and Phase 3 studies. This means they are testing the treatment in patients and measuring clinical outcomes in larger groups.
  • Which conditions are being studied? The studies include post-COVID-19 POTS, sepsis, scoliosis surgery-related blood management, early symptomatic Alzheimer’s disease, pediatric cardiac surgery coagulation, and heart failure with preserved ejection fraction.
  • What kinds of results do the trials measure? The main results include whether patients still meet disease criteria, 28-day mortality, days alive without life-support, blood loss during surgery, clotting test results, adverse events, and how well patients follow the protocol.

Sperimentazioni cliniche in corso su Human Plasma Protein

  • Studio degli effetti del glucagone sulla capacità fisica e il metabolismo in pazienti con insufficienza cardiaca a frazione di eiezione preservata con o senza steatosi epatica metabolica

    In arruolamento

    1 1
    Farmaci in studio:
    Germania

  • Studio sull’uso di proteine plasmatiche umane e combinazione di farmaci per la gestione dei fluidi nei bambini con scoliosi sottoposti a fusione spinale strumentata

    In arruolamento

    1 1 1
    Malattie in studio:
    Farmaci in studio:
    Finlandia

  • Studio sulla personalizzazione del trattamento della sepsi in bambini e adulti con combinazione di farmaci tra cui idrocortisone, anakinra e tocilizumab

    Arruolamento non iniziato

    1 1 1
    Malattie in studio:
    Farmaci in studio:
    Francia

  • Studio sulle differenze di coagulazione tra plasma fresco congelato e plasma solvente-detergente in bambini sottoposti a chirurgia cardiaca congenita

    Arruolamento non iniziato

    1 1 1 1
    Malattie in studio:
    Farmaci in studio:
    Paesi Bassi

  • Studio sull’uso di proteine plasmatiche umane e soluzione salina in pazienti con Alzheimer precoce

    Arruolamento concluso

    1 1
    Malattie in studio:
    Farmaci in studio:
    Norvegia

  • Studio sull’efficacia e sicurezza dell’immunoglobulina umana normale sottocutanea in pazienti adulti con sindrome da tachicardia posturale dopo COVID-19

    Arruolamento concluso

    1 1 1
    Malattie in studio:
    Farmaci in studio:
    Germania Italia Spagna

  • Studio sulla Sicurezza ed Efficacia a Lungo Termine di Fitusiran in Pazienti con Emofilia A o B con o senza Anticorpi Inibitori

    Arruolamento concluso

    1 1 1 1
    Farmaci in studio:
    Danimarca Francia Ungheria Irlanda Italia

Glossario

  • Clinical trial: A research study in people that tests a treatment, procedure, or strategy to see how well it works and how safe it is.
  • Phase 2: An earlier stage of testing in patients. It usually looks at safety and early signs of benefit.
  • Phase 3: A later stage of testing in larger groups of patients. It compares treatments and checks how well they work.
  • Interventional study: A study where researchers give a treatment or procedure and then measure the results.
  • Enrollment: The number of people planned to join a study.
  • Primary outcome: The main result the study is designed to measure.
  • Placebo: A treatment with no active study drug, used for comparison in some trials.
  • Sepsis: A serious condition caused by the body’s extreme response to infection.
  • Postural Orthostatic Tachycardia Syndrome (POTS): A condition where the heart rate rises too much when a person stands up.
  • Coagulation: The process of blood clotting.
  • Life-supportive therapies: Treatments that help keep a person alive, such as breathing support, medicines for blood pressure, or kidney replacement therapy.
  • Feasibility: How practical and possible it is to carry out a study as planned.

Riferimenti

  1. https://studi-clinici.it/studio/studio-sullefficacia-di-igpro20-per-la-sindrome-da-tachicardia-posturale-ortostatica-post-covid-19-negli-adulti/
  2. https://clinicaltrials.gov/study/2025-521371-31-00
  3. https://clinicaltrials.gov/study/2024-514857-31-00
  4. https://studi-clinici.it/studio/studio-sulluso-di-proteine-plasmatiche-umane-e-soluzione-salina-in-pazienti-con-alzheimer-precoce/
  5. https://clinicaltrials.gov/study/2024-514073-22-01
  6. https://clinicaltrials.gov/study/2025-521835-35-00
  7. https://clinicaltrials.gov/study/2023-508884-59-00