Pentaglobin (human immune globulin IV 10%) / Grifols - LARVOL DELTA

PEPPER: Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis (clinicaltrials.gov) - P2 | N=200 | Suspended | Sponsor: RWTH Aachen University | Trial completion date: Dec 2021 ➔ Jan 2027 | Trial primary completion date: Aug 2021 ➔ Sep 2026

Trial completion date • Trial primary completion date • Infectious Disease • Septic Shock • IL6

PEPPER: Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: RWTH Aachen University | Suspended ➔ Recruiting | Trial completion date: Jan 2027 ➔ Mar 2028 | Trial primary completion date: Sep 2026 ➔ Sep 2027

Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease • Septic Shock • IL6

PEPPER: Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis (clinicaltrials.gov) - P2 | N=200 | Suspended | Sponsor: RWTH Aachen University | Recruiting ➔ Suspended

Trial suspension • Infectious Disease • Septic Shock • IL6

PEPPER: Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: RWTH Aachen University | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Septic Shock • IL6

PEPPER: Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: RWTH Aachen University | Trial completion date: Apr 2021 ➔ Dec 2021 | Trial primary completion date: Nov 2020 ➔ Aug 2021

Trial completion date • Trial primary completion date • Infectious Disease • Septic Shock • IL6

PEPPER: Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: RWTH Aachen University

New P2 trial • Infectious Disease • Septic Shock • IL6

Hemodynamic Effect of IgM-Enriched Immunoglobulin in the Early Stage of E. coli-Induced Experimental Sepsis. (PubMed, J Clin Med) - "Subjects and Sepsis was induced in the E. coli bacteriemia (n = 8), E. coli-parallel Pentaglobin treatment (PR-PG; n = 8), and E. coli-delayed Pentaglobin treatment (D-PG; n = 8)...Treated animals showed an initial transient SVRI rise followed by a decline; yet, SVRI remained higher than in untreated sepsis. IgM-enriched immunoglobulin led to a slight stabilization of some hemodynamic parameters, probably due to the reduced extpnfiravasation of fluids into the interstitium and, hence, had an effect on preload."

Journal • Infectious Disease • Septic Shock

The Efficacy of IgM-Enriched Immunoglobulin (eIg) Administration for Treatment of Sepsis and Septic Shock in Adult Surgical Patients: A Single-Center, Retrospective, Observational Study. (PubMed, J Clin Med) - "No other statistically significant differences were observed. Despite the significant limitations of its observational nature, our study suggests that administering eIg may reduce ICU and in-hospital mortality in surgical patients with sepsis and septic shock."

Journal • Observational data • Retrospective data • Critical care • Infectious Disease • Inflammation • Septic Shock

IgA and IgM-enriched Immunoglobulins in Primary Immunodeficiencies: a Pilot Study. (PubMed, J Clin Immunol) - "In patients with severe PID and undetectable IgA/IgM, IgGAM was associated with reduced infections and hospitalizations. Controlled studies are needed to confirm the benefit of IgA/M enriched immunoglobulin preparations in PID patients with persistent and/or recurrent respiratory or digestive infections."

Journal • Immunology • Infectious Disease • Primary Immunodeficiency

AIMing for survival: The impact of the free and total AIM concentration in septic patients. (PubMed, Front Immunol) - "Western blot analysis was performed to detect AIM in human serum IgM and in the IgM-enriched intravenous immunoglobulin IVIG preparation Pentaglobin®...Total AIM concentration is a significant predictor of a 30-day survival in sepsis, supporting its potential use as a prognostic biomarker. Our findings also suggest that AIM may serve as a valuable prognostic biomarker and a potential target for immune-modulating therapies, including IgM-enriched intravenous immunoglobulins (IVIGs)."

Biomarker • Journal • Infectious Disease • Septic Shock

From Crisis to Recovery: Life-Saving IgM-Enriched Immunoglobulin Rescue Therapy in Severe CAP and Refractory Post-Partum Septic Shock - A Dramatic 24-Hour Turnaround. (PubMed, Eur J Case Rep Intern Med) - "IgM-enriched immunoglobulin therapy represents a viable adjunctive option for refractory sepsis, particularly in hyperinflammatory presentations. Early therapeutic intervention within 24 hours of refractory status may optimise clinical outcomes.Phenotype-based therapy selection can identify patients most likely to benefit from immunomodulatory interventions. Postpartum patients may experience worse outcome due to pregnancy-related immune modifications.Biomarker monitoring including procalcitonin and C-reactive protein can guide therapeutic decisions and evaluate treatment response."

Journal • Infectious Disease • Inflammation • Influenza • Nephrology • Obstetrics • Pneumonia • Respiratory Diseases • Septic Shock • CRP

Management of Multi-Drug-Resistant Acinetobacter baumannii Infection in Heart Transplant Patients (ISHLT 2025) - "6 patients with septic shock were treated with iv Pentaglobin 0,25 g/Kg at 12 mL/h for 3 days, a solution containing human plasma proteins, 95 % immunoglobulins (IgG, IgM and IgA). 5 patients developed septic pancytopenia, severe drop of leuocytes, we administered Filgrastim 48 MU for 3 days, an originator recombinant human granulocyte colony-stimulating factor...All other patients are reported fine, leading an autonomous life at home.Conclusion Management of MDR pathogens such as AB is particularly challenging in heart transplants because of concomitant factors of fragility, such as recovering hemodynamics of the early stages and intense immunosuppression. Combining antibiogram-guided therapy, blood purification methods, modulation of immunosuppressants was successful in managing these clinical scenarios."

Clinical • Cerebral Hemorrhage • Hematological Disorders • Infectious Disease • Inflammation • Pneumonia • Respiratory Diseases • Septic Shock • Transplantation

PENTAGLOBIN® AS EARLY ADJUVANT TREATMENT FOR FEBRILE NEUTROPENIA IN HEMATOLOGICAL PATIENTS COLONIZED BY CARBAPENEM-RESISTANT ENTEROBACTERIACEAE OR PSEUDOMONAS AERUGINOSA: PRELIMINARY ANALYSIS OF GITMO STUDY "PENTALLO" (EBMT 2025) - P2 | "Our preliminary data confirm the relevance of colonization or previous infection by CRE and PA in predicting infection by the same pathogen during neutropenia. Pentaglobin® in association to targeted antimicrobial therapy was able to reduce infection-related mortality in neutropenic hematological patients with a colonization or previous infection by CRE or PA. Clinical Trial Registry: EudraCT 2018-001344-57"

Clinical • Bone Marrow Transplantation • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • Pneumonia

PENTALLO: Pentaglobin in CRE and PA Neutropenic Infections (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: Gruppo Italiano Trapianto di Midollo Osseo | Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • Septic Shock • Transplantation

Role of Immunoglobulin in Male Infertility (clinicaltrials.gov) - P=N/A | N=50 | Recruiting | Sponsor: Dr Salma kafeel Qureshi

New trial • Infertility • Sexual Disorders

PENTAGLOBIN® AS EARLY ADJUVANT TREATMENT FOR FEBRILE NEUTROPENIA IN HEMATOLOGICAL PATIENTS COLONIZED BY CARBAPENEM-RESISTANT ENTEROBACTERIACEAE OR PSEUDOMONAS AERUGINOSA: INTERIM ANALYSIS OF GITMO STUDY “PENTALLO" (EBMT 2024) - P2 | "Preliminary data on 84/120 patients show promising results in term of favorable outcome of neutropenic high risk febrile hematologic patients colonized by CRE or PA treated with Pentaglobin® as adjuvant of the best early antibiotic empiric therapy"

Clinical • Bone Marrow Transplantation • Critical care • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • Pneumonia • Septic Shock

PENTAGLOBIN® AS EARLY ADJUVANT TREATMENT FOR FEBRILE NEUTROPENIA IN HEMATOLOGICAL PATIENTS COLONIZED BY CARBAPENEM-RESISTANT ENTEROBACTERIACEAE OR PSEUDOMONAS AERUGINOSA: INTERIM ANALYSIS OF GITMO STUDY “PENTALLO" (EBMT 2024) - P2 | "Preliminary data on 84/120 patients show promising results in term of favorable outcome of neutropenic high risk febrile hematologic patients colonized by CRE or PA treated with Pentaglobin® as adjuvant of the best early antibiotic empiric therapy"

Clinical • Bone Marrow Transplantation • Critical care • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • Pneumonia • Septic Shock

Sepsis Outcome after Major Abdominal Surgery Does Not Seem to Be Improved by the Use of Pentameric Immunoglobulin IgM: A Single-Center Retrospective Analysis. (PubMed, J Clin Med) - "Based on our results, the use of pentameric IgM does not seem to give any clinical advantages in preventing sepsis after major abdominal surgery."

Journal • Retrospective data • Surgery • Infectious Disease • Septic Shock

Potential role of IgM-enriched immunoglobulin as adjuvant treatment in severe SARS-CoV-2 infection. (PubMed, Minerva Anestesiol) - "The present study offers a significant insight concerning the use of IgM-enriched immunoglobulin preparations in patients with SARS-CoV-2 severe infection and also could identifying the specific immunological and biochemical profile of the patient who can more benefit from this therapeutic option."

Journal • Retrospective data • Critical care • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CRP

Biochemical Characterization of a New 10% IVIG Preparation [IgG Next Generation (BT595)/Yimmugo] Obtained from a Manufacturing Process Preserving IgA/IgM Potential of Human Plasma. (PubMed, Drugs R D) - "Yimmugo constitutes a new high quality IVIG preparation derived from a novel manufacturing process that takes advantage of the full therapeutic immunoglobulin potential of human plasma."

Journal • Infectious Disease

PENTALLO: Pentaglobin in CRE and PA Neutropenic Infections (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Gruppo Italiano Trapianto di Midollo Osseo | Trial completion date: Dec 2023 ➔ Jun 2025 | Trial primary completion date: Apr 2023 ➔ Jun 2024

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • Septic Shock • Transplantation

Septic shock due to c. canimorsus treated with igm-enriched immunoglobulin as adjuvant therapy in an immunocompetent woman (ISICEM 2023) - "Adjuvant therapy with IgM-enriched immunoglobulin (Pentaglobin®) was initiated to restore normal values... Data on immunoglobulin therapy in sepsis is conflicting and there is a lack of evidence in patients with invasive C. canimorsus infection. However, following the administration of immunoglobulins the patient showed sustained clinical improvement. Patients with both a high inflammatory load and IgM deficiency might benefit from therapeutic IgM-administration."

Clinical • Critical care • Infectious Disease • Metabolic Disorders • Respiratory Diseases • Septic Shock • IL6

Efficacy and safety of BT595 (10% human intravenous immunoglobulin) in adult patients with chronic immune thrombocytopenia. (PubMed, Transfus Med) - P3 | "The benefit-risk profile of BT595 is favourable."

Journal • Hematological Disorders • Otorhinolaryngology • Pain • Thrombocytopenia • Thrombocytopenic Purpura

BT595, a 10% Human Normal Immunoglobulin, for Replacement Therapy of Primary Immunodeficiency Disease: Results of a Subcohort Analysis in Children. (PubMed, J Clin Immunol) - P3 | "BT595 is effective, convenient, well tolerated, and safe for the treatment of children with PID."

Journal • Immunology • Infectious Disease • Pediatrics • Primary Immunodeficiency

Efficacy, safety and pharmacokinetics of a new 10% normal human immunoglobulin for intravenous infusion, BT595, in children and adults with primary immunodeficiency disease. (PubMed, Vox Sang) - "BT595 is effective, safe and well tolerated for treating patients with PID."

Journal • PK/PD data • Fatigue • Immunology • Infectious Disease • Pain • Primary Immunodeficiency