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Trials |  |
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- trimodulin (BT588) / Grifols
Modulation of NET release by plasma derived immunoglobulins: Trimodulin (polyvalent IgM, IgA, IgG solution) vs. standard IVIg () - Mar 18, 2024 - Abstract #ISICEM2024ISICEM_1179;
The superior immunomodulatory effects of trimodulin on neutrophils could be mediated by the additional IgM and IgA antibodies within trimodulin. Further studies are needed to unravel the mechanism and clinical relevance of these findings.
- ||| trimodulin (BT588) / Grifols
Trial completion date: ESsCAPE: Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP) (clinicaltrials.gov) - Mar 5, 2024
P3, N=590, Recruiting, Sponsor: Biotest
Further studies are needed to unravel the mechanism and clinical relevance of these findings. Trial completion date: Dec 2024 --> Apr 2025
- |||| trimodulin (BT588) / Grifols
Trial completion date, Trial primary completion date: TRICOVID: Efficacy and Safety of Trimodulin (BT588) in Subjects With CAP Including COVID-19 Pneumonia (clinicaltrials.gov) - Nov 18, 2023
P3, N=390, Recruiting, Sponsor: Biotest
Trial completion date: Dec 2024 --> Apr 2025 Trial completion date: Mar 2024 --> Aug 2025 | Trial primary completion date: Mar 2024 --> Aug 2025
- || trimodulin (BT588) / Grifols
P2 data, Retrospective data, Clinical Trial,Phase II, Journal, Immunomodulating: The immunomodulating activity of trimodulin (polyvalent IgM, IgA, IgG solution): a post hoc analysis of the phase II CIGMA trial. (Pubmed Central) - Nov 14, 2023
This effect was particularly marked in patients who also had low baseline IgM values. These findings require confirmation in prospective trials.
- | Pentaglobin (human immune globulin IV 10%) / Grifols
Journal: 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 Central) - Aug 21, 2023
These findings require confirmation in prospective trials. 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.
- |||||| trimodulin (BT588) / Grifols
Enrollment open, Trial initiation date: ESsCAPE: Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP) (clinicaltrials.gov) - Jun 13, 2023
P3, N=590, Recruiting, Sponsor: Biotest
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. Not yet recruiting --> Recruiting | Initiation date: Mar 2023 --> Jun 2023
- |||||||||| trimodulin (BT588) / Grifols
New P3 trial: ESsCAPE: Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP) (clinicaltrials.gov) - Feb 10, 2023
P3, N=590, Not yet recruiting, Sponsor: Biotest
- ||| trimodulin (BT588) / Grifols
Trial completion: ESsCOVID: Efficacy and Safety of Trimodulin in Subjects With Severe COVID-19 (clinicaltrials.gov) - Jan 10, 2023
P2, N=166, Completed, Sponsor: Biotest
Not yet recruiting --> Recruiting | Initiation date: Mar 2023 --> Jun 2023 Active, not recruiting --> Completed
- |||||| trimodulin (BT588) / Grifols
Enrollment open, Trial initiation date: TRICOVID: Efficacy and Safety of Trimodulin (BT588) in Subjects With CAP Including COVID-19 Pneumonia (clinicaltrials.gov) - Dec 22, 2022
P3, N=334, Recruiting, Sponsor: Biotest
Active, not recruiting --> Completed Not yet recruiting --> Recruiting | Initiation date: Sep 2022 --> Jan 2023
- |||||||||| trimodulin (BT588) / Grifols
New P3 trial: TRICOVID: Efficacy and Safety of Trimodulin (BT588) in Subjects With CAP Including COVID-19 Pneumonia (clinicaltrials.gov) - Sep 7, 2022
P3, N=334, Not yet recruiting, Sponsor: Biotest
- | Privigen (human immune globulin intravenous 10%) / CSL Behring, trimodulin (BT588) / Grifols
Journal: Polyvalent immunoglobulin preparations inhibit pneumolysin-induced platelet destruction. (Pubmed Central) - Aug 24, 2022
The capacity to antagonize pneumolysin mainly depended on the final IgG content. As both polyvalent immunoglobulin preparations efficiently prevent pneumolysin-induced platelet destruction and maintain platelet function in vitro, they represent promising candidates for clinical studies on supportive treatment of pneumococcal pneumonia to reduce progression of respiratory distress.
- trimodulin (BT086) / ADMA Biologics
Is trimodulin better? (Copper Hall) - Mar 18, 2022 - Abstract #ISICEM2022ISICEM_481;
- | trimodulin (BT086) / ADMA Biologics
Journal: The Functional Role of IgA in the IgM/IgA-Enriched Immunoglobulin Preparation Trimodulin. (Pubmed Central) - Dec 27, 2021
The fine-tuned balance between immunomodulatory and anti-pathogenic effects of trimodulin were shown to be dose-dependent. Summarized, our data demonstrate the functional role of IgA in trimodulin, highlighting the importance of this immunoglobulin class in immunoglobulin therapy.
- | trimodulin (BT086) / ADMA Biologics
Journal: The Dual Role of a Polyvalent IgM/IgA-Enriched Immunoglobulin Preparation in Activating and Inhibiting the Complement System. (Pubmed Central) - Aug 7, 2021
IgM/IgA provide a balancing effect on the complement system. Trimodulin may enhance phagocytosis and opsonophagocytosis in patients with severe infections and prevent excessive pathogen lysis and release of harmful anaphylatoxins.
- | trimodulin (BT086) / ADMA Biologics
Journal: Immunomodulation: Immunoglobulin Preparations Suppress Hyperinflammation in a COVID-19 Model via FcγRIIA and FcαRI. (Pubmed Central) - Jul 7, 2021
We show that COVID-19 associated inflammation could be reduced by addition of human immunoglobulin preparations (IVIG and trimodulin), while trimodulin elicits stronger immune modulation by more powerful ITAMi signaling. Besides IgG, the IgA component of trimodulin in particular, is of functional relevance for immune modulation in this assay setup, highlighting the need to study IgA mediated immune response.
- || trimodulin (BT588) / Grifols
Enrollment closed: ESsCOVID: Efficacy and Safety of Trimodulin in Subjects With Severe COVID-19 (clinicaltrials.gov) - Jun 8, 2021
P2, N=164, Active, not recruiting, Sponsor: Biotest
Besides IgG, the IgA component of trimodulin in particular, is of functional relevance for immune modulation in this assay setup, highlighting the need to study IgA mediated immune response. Recruiting --> Active, not recruiting
- ||| trimodulin (BT588) / Grifols
Enrollment open: ESsCOVID: Efficacy and Safety of Trimodulin in Subjects With Severe COVID-19 (clinicaltrials.gov) - Oct 7, 2020
P2, N=164, Recruiting, Sponsor: Biotest
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- |||| trimodulin (BT588) / Grifols
New P2 trial: ESsCOVID: Efficacy and Safety of Trimodulin in Subjects With Severe COVID-19 (clinicaltrials.gov) - Oct 5, 2020
P2, N=164, Not yet recruiting, Sponsor: Biotest
- |||| trimodulin (BT588) / Grifols
Trial completion: CIGMA: Safety and Efficacy Study of BT086 to Evaluate Adjunctive Therapy in sCAP (clinicaltrials.gov) - Aug 12, 2015
P2, N=160, Completed, Sponsor: Biotest
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- ||| trimodulin (BT588) / Grifols
Enrollment closed: CIGMA: Safety and Efficacy Study of BT086 to Evaluate Adjunctive Therapy in sCAP (clinicaltrials.gov) - Feb 3, 2015
P2, N=160, Active, not recruiting, Sponsor: Biotest
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- ||| trimodulin (BT588) / Grifols
Enrollment change: CIGMA: Safety and Efficacy Study of BT086 to Evaluate Adjunctive Therapy in sCAP (clinicaltrials.gov) - Mar 6, 2014
P2, N=160, Recruiting, Sponsor: Biotest
Recruiting --> Active, not recruiting N=82 --> 160
- ||||| trimodulin (BT588) / Grifols
New P2 trial: CIGMA: Safety and Efficacy Study of BT086 to Evaluate Adjunctive Therapy in sCAP (clinicaltrials.gov) - Aug 18, 2011
P2, N=160, Recruiting, Sponsor: Biotest