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29 Diseases |  |
6 Trials |
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6 Trials |  |
217 News |  |
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- || Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Clinical, PK/PD data, Journal: Population pharmacokinetic analysis of weekly and biweekly IgPro20 (Hizentra®) dosing in patients with primary immunodeficiency. (Pubmed Central) - Jan 8, 2021
The present analysis validated the ability of the previously published popPK model to predict serum IgG concentration time profiles after biweekly subcutaneous IgPro20 administration.
- || Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Clinical, Journal: Patient-reported outcomes with subcutaneous immunoglobulin in chronic inflammatory demyelinating polyneuropathy: the PATH Study. (Pubmed Central) - Dec 30, 2020
The present analysis validated the ability of the previously published popPK model to predict serum IgG concentration time profiles after biweekly subcutaneous IgPro20 administration. IgPro20 maintained, or improved, QOL in most subjects with CIDP, consistent with the PATH study findings that both IgPro20 doses were efficacious in maintaining CIDP.
- |||||| Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
New trial: Hizentra (clinicaltrials.gov) - Dec 16, 2020
P, N=100, Not yet recruiting, Sponsor: CSL Behring
- Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
[VIRTUAL] Self-assessment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) in the course of switching from IVIg therapy to subcutaneous immunoglobulins () - Dec 6, 2020 - Abstract #DGN2020DGN_1227;
Background: Hizentra®, the first subcutaneous immunoglobulin preparation, has been used in maintenance therapy since 2018 Patients with chronic inflammatory demyelinating polyneuropathy (CIDP) are admitted after stabilization with intravenous immunoglobulins (IVIg)... The results of our study show that the switch from intravenous to subcutaneous immunoglobulins in patients with CIDP from a neuropsychiatric point of view, as well as aspects of everyday life Enable a stable course of life and is preferred by patients.
- Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
[VIRTUAL] Clinical stability in patients with CIDP after switching from IVIg to subcutaneous immunoglobulins () - Nov 28, 2020 - Abstract #DGN2020DGN_277;
The results show that the switch to subcutaneous immunoglobulins is successful. Just Few patients required a small increase in the dose of subcutaneous immunoglobulins in order to maintain stability to keep.
- || Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Clinical, PK/PD data, Journal: Pharmacodynamic Properties of Subcutaneous Immunoglobulin in Myasthenia Gravis: Sub-analyses From an Open-Label Trial. (Pubmed Central) - Sep 30, 2020
The change in clinical scores was not significantly associated with IgG levels suggesting a complex relationship. SCIg may be effective for both ocular and generalized presentations of MG.
- || Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Clinical, Journal: Long-term safety and efficacy of subcutaneous immunoglobulin IgPro20 in CIDP: PATH extension study. (Pubmed Central) - Sep 26, 2020
To investigate the long-term safety and efficacy of weekly subcutaneous IgPro20 (Hizentra, CSL Behring) in chronic inflammatory demyelinating polyneuropathy (CIDP)...Long-term dosing should be individualized to find the most appropriate dose in a given patient. This study provides Class IV evidence that for patients with CIDP, long-term treatment with SCIG beyond 24 weeks is safe and efficacious.
- || Ilaxten (bilastine) / Otsuka
Clinical, Retrospective data, Journal: Pediatric subset of primary immunodeficiency patients treated with SCIG: post hoc analysis of SHIFT and IBIS pooled data. (Pubmed Central) - Sep 20, 2020
After adjusting for potential confounders, the annualized rate of infections was similar between SHIFT and IBIS patients (incidence rate ratio = 1.09, 90% CI 0.72-1.67); only 1 serious bacterial infection was experienced by a patient in the IBIS group. In pediatric PID patients, weekly and biweekly Hizentra administrations appeared equally effective treatment options.
- | Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Review, Journal: Immune Globulin Subcutaneous (Human) 20% (Hizentra): A Review in Chronic Inflammatory Demyelinating Polyneuropathy. (Pubmed Central) - Sep 13, 2020
In PATH, more than one-half of IgPro20 recipients preferred this therapy to their previous IVIg therapy. IgPro20 offers a convenient alternative to IVIg with a better systemic AEs profile and thus extends the options for maintenance therapy in CIDP.
- Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
[VIRTUAL] New Data on High Infusion Volumes and Flow Rates of Pump-Administered Hizentra® (Hall B) - Sep 2, 2020 - Abstract #ESID2020ESID_92;
- Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Feasibility of subcutaneous IgPro20 administration via manual push at high flow rates in patients with primary immunodeficiency: Findings of the HILO Study (Ponce Exhibit Hall 1, 2, & 3,) - Aug 28, 2020 - Abstract #EAC2020EAC_54;
P4
Higher manual push flow rates may allow patients to individualize their SCIg therapy by reducing infusion time. Funding: CSL Behring
- Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
The HILO Study: High volumes and flow rates of subcutaneous IgPro20 pump-assisted infusions in patients with primary immunodeficiency (Ponce Exhibit Hall 1, 2, & 3,) - Aug 28, 2020 - Abstract #EAC2020EAC_53;
P4
Increasing infusion parameters had no negative impact on the tolerability of IgPro20. Funding: CSL Behring
- Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Safety profile of high IgPro20 infusion parameters in patients with primary immunodeficiency (PID): Results from The Forced Upward Titration HILO Study (Ponce Exhibit Hall 1, 2, & 3,) - Aug 28, 2020 - Abstract #EAC2020EAC_51;
P4
No new safety signals were reported, and no trends indicated an increase in TEAE intensity or frequency with increasing flow rate or volume. Funding: CSL Behring
- Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Feasibility of subcutaneous IgPro20 administration via manual push at high flow rates in patients with primary immunodeficiency: Findings of the HILO Study (Ponce Exhibit Hall 1, 2, & 3,) - Aug 28, 2020 - Abstract #EAC2020EAC_13;
P4
Higher manual push flow rates may allow patients to individualize their SCIg therapy by reducing infusion time. Funding: CSL Behring
- Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
The HILO Study: High volumes and flow rates of subcutaneous IgPro20 pump-assisted infusions in patients with primary immunodeficiency (Ponce Exhibit Hall 1, 2, & 3,) - Aug 28, 2020 - Abstract #EAC2020EAC_12;
P4
Increasing infusion parameters had no negative impact on the tolerability of IgPro20. Funding: CSL Behring
- Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Safety profile of high IgPro20 infusion parameters in patients with primary immunodeficiency (PID): Results from The Forced Upward Titration HILO Study (Ponce Exhibit Hall 1, 2, & 3,) - Aug 28, 2020 - Abstract #EAC2020EAC_10;
P4
No new safety signals were reported, and no trends indicated an increase in TEAE intensity or frequency with increasing flow rate or volume. Funding: CSL Behring
- | Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Trial completion, Trial completion date, Trial primary completion date: Humoral Immunodeficiency in CLL and Therapy With Subcutaneous Ig (clinicaltrials.gov) - Aug 25, 2020
P2/3, N=20, Completed, Sponsor: Rochester General Hospital
Funding: CSL Behring Recruiting --> Completed | Trial completion date: Nov 2020 --> Jul 2020 | Trial primary completion date: Nov 2020 --> Jul 2020
- || Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Trial completion date: RECLAIIM: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) (clinicaltrials.gov) - Aug 7, 2020
P3, N=126, Recruiting, Sponsor: CSL Behring
Recruiting --> Completed | Trial completion date: Nov 2020 --> Jul 2020 | Trial primary completion date: Nov 2020 --> Jul 2020 Trial completion date: Jan 2023 --> Feb 2024
- | Ilaxten (bilastine) / Otsuka
Retrospective data, Journal: Correlations Among Subcutaneous Immunoglobulin Dosage, Immunoglobulin G Serum Pre-infusional Levels and Body Mass Index in Primary Antibody Deficiency Patients: A Pooled Analysis from the SHIFT/IBIS Studies. (Pubmed Central) - Jul 29, 2020
Trial completion date: Jan 2023 --> Feb 2024 These findings support the concept that the cumulative monthly dose of SCIG and the dose of SCIG per kilogram of body weight affect IgG trough levels in PAD patients, irrespective of BMI.
- |||| Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Enrollment open: RECLAIIM: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) (clinicaltrials.gov) - Jul 7, 2020
P3, N=126, Recruiting, Sponsor: CSL Behring
These findings support the concept that the cumulative monthly dose of SCIG and the dose of SCIG per kilogram of body weight affect IgG trough levels in PAD patients, irrespective of BMI. Active, not recruiting --> Recruiting
- || Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Clinical, Observational data, Journal: Czech Hizentra Noninterventional Study With Rapid Push: Efficacy, Safety, Tolerability, and Convenience of Therapy With 20% Subcutaneous Immunoglobulin. (Pubmed Central) - Jul 7, 2020
(Clin Ther. 2019;XX:XXX-XXX)
- Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
[VIRTUAL] SUBCUTANEOUS IMMUNOGLOBULIN REPLACEMENT THERAPY IN PATIENTS WHO UNDERWENT ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION (HCT): A PROSPECTIVE STUDY TO MEASURE FEASIBILITY, SAFETY AND HEALTH CARE RESOURCE USE (ePoster Area) - Jul 3, 2020 - Abstract #EBMT2020EBMT_3847;
P=N/A
Cutaneous GVHD did not impair ScIG administration. Patients were able to incorporate ScIG therapy into their weekly routine, with administrations being successfully performed at home.
- Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
[VIRTUAL] SUBCUTANEOUS IMMUNOGLOBULIN REPLACEMENT THERAPY IN PATIENTS WHO UNDERWENT ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION (HCT): A PROSPECTIVE STUDY TO MEASURE FEASIBILITY, SAFETY AND HEALTH CARE RESOURCE USE (ePoster Area) - Jul 3, 2020 - Abstract #EBMT2020EBMT_3846;
P=N/A
Cutaneous GVHD did not impair ScIG administration. Patients were able to incorporate ScIG therapy into their weekly routine, with administrations being successfully performed at home.
- Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
[VIRTUAL] SUBCUTANEOUS IMMUNOGLOBULIN REPLACEMENT THERAPY IN PATIENTS WHO UNDERWENT ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION (HCT): A PROSPECTIVE STUDY TO MEASURE FEASIBILITY, SAFETY AND HEALTH CARE RESOURCE USE (ePoster Area) - Jul 3, 2020 - Abstract #EBMT2020EBMT_3845;
P=N/A
Cutaneous GVHD did not impair ScIG administration. Patients were able to incorporate ScIG therapy into their weekly routine, with administrations being successfully performed at home.
- || Privigen (human immune globulin intravenous 10%) / CSL Behring, Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Enrollment open: Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc) (clinicaltrials.gov) - Jun 25, 2020
P2, N=26, Recruiting, Sponsor: CSL Behring
Patients were able to incorporate ScIG therapy into their weekly routine, with administrations being successfully performed at home. Active, not recruiting --> Recruiting
- Hizentra (human immune globulin subcutaneous 20%) / CSL Behring, Tirosint (levothyroxine) / IBSA Institute Biochemical SA
[VIRTUAL] Detection of Thyroid Cancer Recurrence in Patients with Positive Thyroglobulin Antibody Receiving Immunoglobulin Therapy () - Jun 20, 2020 - Abstract #ENDOI2020ENDO-I_2187;
In patients with negative Tg levels, but elevated thyroglobulin antibody while receiving immune globulin therapy, thyroglobulin antibody levels may not be a reliable indicator of thyroid cancer recurrence. Measurement of Tg levels using a LC-MS may provide some clarity.
- | Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Journal: Restabilization treatment after IVIG withdrawal in chronic inflammatory demyelinating polyneuropathy. Results from the pre-randomization phase of the Polyneuropathy and Treatment with Hizentra® (PATH) study. (Pubmed Central) - Jun 8, 2020
Nine subjects were reported to have improved, leaving a maximum of 27 subjects (13%) who either showed no signs of clinical improvement during the restabilization phase and 4 weeks post-study or withdrew for other reasons. Sudden IVIG withdrawal was effective in detecting ongoing immunoglobulin G (IgG) dependency with a small risk for subjects not returning to their baseline 17 weeks after withdrawal.
- || Privigen (human immune globulin intravenous 10%) / CSL Behring, Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Clinical, Journal: Efficacy and safety of IVIG in CIDP: combined data of the PRIMA and PATH studies. (Pubmed Central) - Jun 8, 2020
P3
Sudden IVIG withdrawal was effective in detecting ongoing immunoglobulin G (IgG) dependency with a small risk for subjects not returning to their baseline 17 weeks after withdrawal. This analysis confirms the efficacy and safety of IgPro10, a recently FDA-approved IVIG for CIDP, in a population of mainly pre-treated subjects with CIDP.
- | Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Buongiorno professore, mia figlia con trisomia 13 e (fra le altre cose.. ) ICV assume regolarmente immunoglobuline tramite Hizentra. Potrebbe questo fornirle una protezione più specifica?Grazie (Twitter) - May 18, 2020
- |||| Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Enrollment closed: RECLAIIM: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) (clinicaltrials.gov) - Apr 3, 2020
P3, N=126, Active, not recruiting, Sponsor: CSL Behring
This analysis confirms the efficacy and safety of IgPro10, a recently FDA-approved IVIG for CIDP, in a population of mainly pre-treated subjects with CIDP. Recruiting --> Active, not recruiting
- Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Feasibility of Subcutaneous IgPro20 Administration via Manual Push at High Flow Rates in Patients with Primary Immunodeficiency: Findings of the HILO Study (Convention Center, 200 Level, Hall D) - Mar 1, 2020 - Abstract #AAAAI2020AAAAI_1858;
P4
RATIONALE: Safety of high infusion parameters of subcutaneous IgPro20 (Hizentra®, CSL Behring, United States) administration has not been studied previously... Manual IgPro20 push infusions at high flow rate of up to 2 mL/min are feasible in most PID patients.
- Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
The HILO Study: High Volumes and Flow Rates of Subcutaneous IgPro20 Pump-assisted Infusions in Patients with Primary Immunodeficiency (Convention Center, 200 Level, Hall D) - Mar 1, 2020 - Abstract #AAAAI2020AAAAI_1856;
P4
RATIONALE: The Hizentra Label Optimization (HILO) study evaluated the safety and tolerability of high infusion parameters of subcutaneous IgPro20 (Hizentra®, CSL Behring) administration in patients with primary immunodeficiency (PID)... Despite decreasing responder rates, pump-assisted IgPro20 infusions are feasible at high infusion parameters in most patients, allowing shorter infusion times and thereby improved administration convenience.
- Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Safety Profile of High IgPro20 Infusion Parameters in Patients with Primary Immunodeficiency (PID): Results from The Forced Upward Titration HILO Study (Convention Center, 200 Level, Hall D) - Mar 1, 2020 - Abstract #AAAAI2020AAAAI_1113;
P4
RATIONALE: The Hizentra Label Optimization (HILO) study (NCT03033745) assessed safety and tolerability of increasing infusion rates/volumes of subcutaneous IgPro20 (Hizentra®) in PID patients... High infusion parameters for pump-assisted and manual push subcutaneous IgPro20 infusions were tolerated well.
- Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
[VIRTUAL] SUBCUTANEOUS IMMUNOGLOBULIN REPLACEMENT THERAPY IN PATIENTS WHO UNDERWENT ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION (HCT): A PROSPECTIVE STUDY TO MEASURE FEASIBILITY, SAFETY AND HEALTH CARE RESOURCE USE (ePoster Area) - Feb 8, 2020 - Abstract #EBMT2020EBMT_1452;
P=N/A
Cutaneous GVHD did not impair ScIG administration. Patients were able to incorporate ScIG therapy into their weekly routine, with administrations being successfully performed at home.
- Hizentra (human immune globulin subcutaneous 20%) / CSL Behring, Tirosint (levothyroxine) / IBSA Institute Biochemical SA
Detection of Thyroid Cancer Recurrence in Patients with Positive Thyroglobulin Antibody Receiving Immunoglobulin Therapy. (ENDOExpo) - Feb 7, 2020 - Abstract #ENDO2020ENDO_3377;
In patients with negative Tg levels, but elevated thyroglobulin antibody while receiving immune globulin therapy, thyroglobulin antibody levels may not be a reliable indicator of thyroid cancer recurrence. Measurement of Tg levels using a LC-MS may provide some clarity.
- || Hizentra (human immune globulin subcutaneous 20%) / CSL Behring, NN1213 / Novo Nordisk
Trial completion: Open Label Study of Subcutaneous Immunoglobulin (SCIg) in Myasthenia Gravis (clinicaltrials.gov) - Dec 13, 2019
P2, N=23, Completed, Sponsor: Mazen Dimachkie, MD
Measurement of Tg levels using a LC-MS may provide some clarity. Active, not recruiting --> Completed
- | Privigen (human immune globulin intravenous 10%) / CSL Behring, Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Enrollment closed: Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc) (clinicaltrials.gov) - Nov 6, 2019
P2, N=26, Active, not recruiting, Sponsor: CSL Behring
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- | Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Enrollment open: RECLAIIM: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) (clinicaltrials.gov) - Oct 24, 2019
P3, N=126, Recruiting, Sponsor: CSL Behring
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- | Privigen (human immune globulin intravenous 10%) / CSL Behring, Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
New P2 trial: Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc) (clinicaltrials.gov) - Oct 22, 2019
P2, N=26, Recruiting, Sponsor: CSL Behring
- | Ilaxten (bilastine) / Otsuka, Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Clinical, Observational data, Journal: Biweekly Hizentra® in Primary Immunodeficiency: a Multicenter, Observational Cohort Study (IBIS). (Pubmed Central) - Oct 18, 2019
All patients were either very (76.5%) or quite (23.5%) satisfied with biweekly Hizentra® at the end of the study. In conclusion, the IBIS study provided real-world evidence on the efficacy of biweekly Hizentra® in patients with PIDs, thus verifying the data generated by the pharmacometric modeling and simulation study in a normal clinical setting.
- | Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Clinical, P3 data, Journal: Long-Term Efficacy and Safety of Hizentra® in Patients with Primary Immunodeficiency in Japan, Europe, and the United States: a Review of 7 Phase 3 Trials. (Pubmed Central) - Oct 2, 2019
The results from these seven studies indicate that Hizentra® therapy was both efficacious and well tolerated during long-term treatment. This is particularly important in patients with PID, who may require lifelong IgG replacement therapy.
- | Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Retrospective data, Journal: Treatment Satisfaction with Subcutaneous Immunoglobulin Replacement Therapy in Patients with Primary Immunodeficiency: a Pooled Analysis of Six Hizentra® Studies. (Pubmed Central) - Oct 2, 2019
These results showed that switching patients from IVIG to SCIG improves patient self-reported health status and IgG-specific HRQOL perception. The maintenance studies generally showed no deterioration of this improved health status over a long follow-up period.
- | Ilaxten (bilastine) / Otsuka
Clinical, Journal: Subcutaneous Immunoglobulin Twenty Percent Every Two Weeks in Pediatric Patients with Primary Immunodeficiencies: Subcohort Analysis of the IBIS Study. (Pubmed Central) - Sep 13, 2019
The maintenance studies generally showed no deterioration of this improved health status over a long follow-up period. Background:Biweekly Hizentra is a noninferior option with respect to previous IVIG/SCIG-based treatment.
- | Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Clinical, Journal: Long-term safety and efficacy of subcutaneous immunoglobulin IgPro20 in CIDP: PATH extension study. (Pubmed Central) - Aug 29, 2019
Subcutaneous treatment with IgPro20 provided long-term benefit at both 0.4 and 0.2 g/kg weekly doses with lower relapse rates on the higher dose. Long-term dosing should be individualized to find the most appropriate dose in a given patient.
- | Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Journal: IgPro20, the Polyneuropathy and Treatment with Hizentra study (PATH), and the treatment of chronic inflammatory demyelinating polyradiculoneuropathy with subcutaneous IgG. (Pubmed Central) - Aug 7, 2019
Local adverse events were mostly mild or moderate, and systemic adverse events were infrequent. Some patients may prefer maintenance therapy with SCIG over IVIG.
- | Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
New P3 trial: RECLAIIM: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) (clinicaltrials.gov) - Aug 4, 2019
P3, N=126, Not yet recruiting, Sponsor: CSL Behring
- ||| Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Trial completion, Trial completion date, Trial primary completion date: ScIGalloHCT: Subcutaneous Ig in Allogeneic Stem Cell Transplant Recipients (clinicaltrials.gov) - May 9, 2019
P=N/A, N=20, Completed, Sponsor: University Health Network, Toronto
Some patients may prefer maintenance therapy with SCIG over IVIG. Recruiting --> Completed | Trial completion date: Jan 2020 --> May 2019 | Trial primary completion date: Dec 2018 --> May 2019
- | Privigen (human immune globulin intravenous 10%) / CSL Behring, Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Clinical, Journal: Therapeutic Human IgG Preparations Contain Mixture of HLA Antibodies to Native HLA Antigens and Cryptic Epitopes with Little Clinical Significance. (Pubmed Central) - May 7, 2019
Recruiting --> Completed | Trial completion date: Jan 2020 --> May 2019 | Trial primary completion date: Dec 2018 --> May 2019 The H-Ig products tested consisted of low titer, noncomplement binding HLA Class I and Class II antibodies; most of the observed Class I HLA reactivity was towards denatured HLA antigens.
- | Hizentra (human immune globulin subcutaneous 20%) / CSL Behring, NN1213 / Novo Nordisk
Trial completion date: SCIG: Subcutaneous Immunoglobulin for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (clinicaltrials.gov) - Apr 22, 2019
P=N/A, N=20, Active, not recruiting, Sponsor: University of South Florida
The H-Ig products tested consisted of low titer, noncomplement binding HLA Class I and Class II antibodies; most of the observed Class I HLA reactivity was towards denatured HLA antigens. Trial completion date: Dec 2018 --> Dec 2019
- Hizentra (human immune globulin subcutaneous 20%) / CSL Behring, NN1213 / Novo Nordisk
Phase classification: SIMM: Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis (clinicaltrials.gov) - Apr 20, 2019
P1, N=4, Terminated, Sponsor: St. Louis University
Trial completion date: Dec 2018 --> Dec 2019 Phase classification: P=N/A --> P1