In short
Clinical trials of Immunoglobulin G are studying its use in serious infections and blood cancer-related infection risk. These studies look at whether treatment can improve survival and reduce organ failure in adults with peritonitis, septic shock, or acute myeloid leukemia. The trials mainly test safety and effectiveness in hospital patients.
Key points
- Clinical trials of Immunoglobulin G are focused on serious hospital conditions, including peritonitis, septic shock, and acute myeloid leukemia. The studies are testing whether treatment can improve survival and reduce organ failure. Two trials are in Phase 2 and one is in Phase 3. The target groups are adults with severe infection or patients at high risk of infection during leukemia treatment or stem cell transplantation. The main endpoints include mortality, overall survival, and multiple organ failure score. All three trials are authorised.
Clinical trials overview
These studies are testing Immunoglobulin G-related treatment in people with very serious infection-related conditions and in patients with acute myeloid leukemia who are at high risk of infection. All three trials are interventional studies, which means the researchers give a treatment and then measure the results.
The listed trials are all authorised and are in Phase 2 or Phase 3. Phase 2 trials usually look for early signs that a treatment may help, while Phase 3 trials test the treatment in a larger group to see if it works better than standard care.
Peritonitis and sepsis study
NCT03334006 is a Phase 2 study in 200 patients with secondary or quaternary peritonitis and sepsis. The trial is called a prospective, randomized study of personalized medicine after infectious source control in peritonitis patients.
Source control means the medical or surgical step used to remove the cause of infection, such as cleaning an infected area. This trial measures the change in multiple organ failure (MOF) score from the start of treatment to day 7 after source control. The MOF score looks at the lungs, heart, kidneys, liver, and blood, so it shows whether organ function is improving or getting worse.
Acute myeloid leukemia study
Trial 2024-518940-19-02 is a Phase 2 study in 120 patients with Acute Myeloid Leukemia (AML). The brief summary says the study is looking at whether early addition of Pentaglobin to the best available antimicrobial therapy can reduce mortality and improve survival in neutropenic febrile patients with acute leukemia or after allogeneic hematopoietic stem cell transplantation (HSCT) who are colonized by carbapenem-resistant Enterobacteriaceae (CRE) or Pseudomonas aeruginosa (PA).
Neutropenic means the patient has a low number of neutrophils, which are white blood cells that help fight infection. The study plans two co-primary endpoints: a 50% reduction in 30-day mortality for patients who develop a pre-engraftment bloodstream infection caused by CRE or PA, and a 20% increase in overall survival at 4 months from the start of intensive treatment compared with historical controls.
Septic shock study
Trial 2024-518096-57-00 is a Phase 3, multicenter, randomized, single-blinded, two-arm, adaptive study in 356 patients with septic shock. The study tests adjunctive IgM-enriched immunoglobulin therapy with a personalized dose based on serum IgM-titers versus a standard dose.
The primary objective is to see whether the personalized dose is better than the flat dose at reducing all-cause mortality at day 28. All-cause mortality means death from any cause during the study period. This trial is focused on whether a tailored dosing approach can improve short-term survival in very sick patients with septic shock.
Main endpoints and what they mean
The trials measure outcomes that show whether patients live longer or recover better after treatment. In the peritonitis study, the main endpoint is the change in MOF score by day 7 after source control. In the leukemia study, the endpoints are 30-day mortality and overall survival at 4 months. In the septic shock study, the endpoint is all-cause mortality at day 28.
These endpoints are important because they show both early and later treatment benefit. They also help researchers compare the study treatment with usual care or historical controls.
Who the studies are for
These trials are not for healthy volunteers; they focus on patients with serious illness. The target groups include adults with peritonitis and sepsis, patients with septic shock, and patients with acute myeloid leukemia or after allogeneic stem cell transplantation who are at risk of difficult-to-treat infections.
Because the studies are hospital-based and involve severe disease, the main focus is on safety signals, survival, and recovery from organ stress.