- |||||||||| Privigen (human immune globulin intravenous 10%) / CSL Behring, Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Enrollment closed, Trial completion date, Trial primary completion date: IVIG Vs SCIG in CIDP (clinicaltrials.gov) - Nov 14, 2024
P1, N=20, Active, not recruiting,
Recruiting --> Active, not recruiting | Trial completion date: Oct 2024 --> Dec 2025 | Trial primary completion date: Oct 2024 --> Dec 2025
- |||||||||| Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
AN UNUSUAL REACTION TO HIZENTRA (SUBCUTANEOUS IMMUNE GLOBULIN (HUMAN) 20% LIQUID) (Monitor 1; Hall A) - Sep 29, 2024 - Abstract #ACAAI2024ACAAI_1054;
Hizentra is a 20% solution that contains L-proline and polysorbate 80 whereas Privigen is a 10% solution with L-proline, and both have very low IgA content, <50 mcg/mL and <25 mcg/mL respectively. Urticarial Reaction to Subcutaneous Immune Globulin These recurring, pruritic, erythematous urticarial lesions were present on the arms and torso within hours of subcutaneous immune globulin infusion.
- |||||||||| Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Enrollment open, Trial primary completion date: Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS (clinicaltrials.gov) - Sep 19, 2024
P3, N=177, Recruiting,
Urticarial Reaction to Subcutaneous Immune Globulin These recurring, pruritic, erythematous urticarial lesions were present on the arms and torso within hours of subcutaneous immune globulin infusion. Not yet recruiting --> Recruiting | Trial primary completion date: Feb 2027 --> Sep 2027
- |||||||||| Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Trial completion date, Trial primary completion date: Hizentra (clinicaltrials.gov) - Apr 19, 2024
P=N/A, N=100, Recruiting,
Trial completion date: Nov 2027 --> May 2028 | Trial primary completion date: Jun 2024 --> May 2028 Trial completion date: Sep 2024 --> Dec 2027 | Trial primary completion date: Sep 2024 --> Dec 2027
- |||||||||| Hizentra (human immune globulin subcutaneous 20%) / CSL Behring, HyQvia (immune globulin infusion 10% (human) with recombinant human hyaluronidase) / Halozyme, Takeda
Infusion-related Costs for HyQvia Compared to Hizentra in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_3316;
Treatment with fSCIG-10% resulted in total annual savings of $1676 per person with CIDP. Savings are attributed to less-frequent administration, resulting in fewer per-person infusion costs and nursing hours.
- |||||||||| Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Enrollment open: Usage of Spirometry in Managing IgG Therapy in CVID With Airway Disease (clinicaltrials.gov) - Mar 4, 2024
P4, N=22, Recruiting,
Savings are attributed to less-frequent administration, resulting in fewer per-person infusion costs and nursing hours. Not yet recruiting --> Recruiting
- |||||||||| Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Journal: Safety and Efficacy of Hizentra (Pubmed Central) - Jun 2, 2023
Not yet recruiting --> Recruiting Hizentra
- |||||||||| Hizentra (human immune globulin subcutaneous 20%) / CSL Behring, NN1213 / Novo Nordisk
Trial completion, Trial completion date, Trial primary completion date: A Pilot Trial To Assess The Feasibility And Efficacy Of SCIG In Patients With MG Exacerbation (SCIG-MG) (clinicaltrials.gov) - Feb 21, 2023
P3, N=26, Completed,
Hepatitis B core antibody screening should be considered standard practice for each human normal immunoglobulin administration, effectively improving therapeutic decisions by preventing wrong diagnosis of hepatitis B exposure and therefore preventing unnecessary anti-viral use. Recruiting --> Completed | Trial completion date: Apr 2024 --> Oct 2022 | Trial primary completion date: Apr 2024 --> Oct 2022
- |||||||||| Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
An Unusually Delayed Presentation of X-Linked Agammaglobulinemia (XLA) () - Feb 4, 2023 - Abstract #AAAAI2023AAAAI_1421;
Ultimately, BTK protein expression gene testing confirmed the diagnosis of X-linked agammaglobulinemia. Patient has had no further admissions or serious infections.
- |||||||||| Privigen (human immune globulin intravenous 10%) / CSL Behring, Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
New P1 trial: IVIG Vs SCIG in CIDP (clinicaltrials.gov) - Oct 18, 2022
P1, N=20, Recruiting,
- |||||||||| Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Journal, Real-world evidence: Real-world results with IgPro20 for hypo- or agammaglobulinemia in Japan. (Pubmed Central) - Sep 25, 2022
Trial completion date: Feb 2024 --> Nov 2027 | Trial primary completion date: Sep 2022 --> Jun 2024 IgPro20 was considered safe and effective among patients with agammaglobulinemia or hypogammaglobulinemia due to PID or SID in Japan.
- |||||||||| Privigen (human immune globulin intravenous 10%) / CSL Behring, Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Trial completion: Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc) (clinicaltrials.gov) - Aug 3, 2022
P2, N=27, Completed,
Furthermore, it has also led to an improvement in quality of life and increased comfort, as the patients themselves have stated. Active, not recruiting --> Completed
- |||||||||| Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Enrollment open: Hizentra (clinicaltrials.gov) - May 11, 2022
P=N/A, N=100, Recruiting,
Trial completion date: Dec 2018 --> Apr 2024 | Trial primary completion date: Oct 2018 --> Apr 2024 Suspended --> Recruiting
- |||||||||| Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Trial completion date, Trial primary completion date: Usage of Spirometry in Managing IgG Therapy in CVID With Airway Disease (clinicaltrials.gov) - Mar 28, 2022
P4, N=22, Not yet recruiting,
These criteria help define SID patients who may benefit from IgRT. Trial completion date: Feb 2023 --> Dec 2026 | Trial primary completion date: Feb 2022 --> Dec 2025
- |||||||||| Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Biomarker, Retrospective data, Journal: Replacement and Immunomodulatory Activities of 20% Subcutaneous Immunoglobulin Treatment: A Single-Center Retrospective Study in Autoimmune Myositis and CVID Patients. (Pubmed Central) - Feb 26, 2022
To this aim, a long-term evaluation of the effectiveness of 20% human SCIg treatment (20% SCIg, Hizentra, CSL Behring) was carried out in patients with PM/DM in care at our Center...The frequency of the adverse events reported by PM/DM patients was not different from what reported in CVID patients, where the use of SCIg therapy is more consolidated. This study suggests that 20% SCIg treatment represents a viable and safe treatment for PM/DM patients and a valid therapeutic alternative to IVIg, with important advantages for patients' quality of life.
- |||||||||| Hizentra (human immune globulin subcutaneous 20%) / CSL Behring, HyQvia (immune globulin infusion 10% (human) with recombinant human hyaluronidase) / Halozyme, Takeda, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Treatment of myelin oligodendrocyte glycoprotein antibody associated disease with subcutaneous immune globulin (Virtual Poster Hall) - Feb 20, 2022 - Abstract #ACTRIMSForum2022ACTRIMS_Forum_384;
Notably, these findings are in line with reports in other autoimmune neurological diseases, including autoimmune peripheral neuropathies and myasthenia gravis, in which SCIG appears to exhibit similar efficacy to IVIG, with potential reductions in systemic adverse effects. Our findings support the rationale for prospective randomized studies investigating the efficacy of SCIG for relapse prevention in MOGAD.
- |||||||||| Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Clinical, Journal: Pharmacometric Analysis Linking Immunoglobulin Exposure to Clinical Efficacy Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy. (Pubmed Central) - Feb 1, 2022
The two main objectives of this analysis were to (i) characterize the relationship between immunoglobulin (Ig) exposure and chronic inflammatory demyelinating polyneuropathy (CIDP) disease severity using data from 171 patients with CIDP who received either subcutaneous Ig (IgPro20; Hizentra ) or placebo (PATH study), and to (ii) simulate and compare exposure coverage with various dosing approaches considering weekly dosing to be the reference dose...Treatment-related changes in inflammatory neuropathy cause and treatment (INCAT) scores were best described by an E model as a function of ΔIgG (total serum IgG at INCAT score assessment minus baseline IgG levels before intravenous Ig restabilisation). Simulations indicate that flexible dosing from daily to biweekly (every other week) provide an exposure coverage equivalent to that of a weekly Ig dose.
- |||||||||| Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Clinical, Review, Journal: Placebo Effect in Chronic Inflammatory Demyelinating Polyneuropathy: The PATH study and a systematic review. (Pubmed Central) - Sep 29, 2021
The Polyneuropathy And Treatment with Hizentra (PATH) study required subjects with chronic inflammatory demyelinating polyneuropathy (CIDP) to show dependency on immunoglobulin G (IgG) and then be restabilized on IgG before being randomized to placebo or one of two doses of subcutaneous immunoglobulin (SCIG)...Interpretation Placebo is an important variable in the design of CIDP trials. Trials designed to show clinical improvement will have a significantly lower effect of this phenomenon than those designed to show stability or deterioration.
- |||||||||| Privigen (human immune globulin intravenous 10%) / CSL Behring, Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Enrollment closed, Trial completion date, Trial primary completion date: Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc) (clinicaltrials.gov) - Sep 28, 2021
P2, N=27, Active, not recruiting,
Trials designed to show clinical improvement will have a significantly lower effect of this phenomenon than those designed to show stability or deterioration. Recruiting --> Active, not recruiting | Trial completion date: Aug 2021 --> May 2022 | Trial primary completion date: Aug 2021 --> May 2022
- |||||||||| Hizentra (human immune globulin subcutaneous 20%) / CSL Behring, NN1213 / Novo Nordisk
Trial completion, Trial completion date: SCIG: Subcutaneous Immunoglobulin for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (clinicaltrials.gov) - Sep 16, 2021
P=N/A, N=20, Completed,
Recruiting --> Active, not recruiting | Trial completion date: Aug 2021 --> May 2022 | Trial primary completion date: Aug 2021 --> May 2022 Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> May 2021
- |||||||||| Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Clinical, PK/PD data, Journal: Pharmacokinetic Analysis of Weekly Versus Biweekly IgPro20 Dosing in Patients With Primary Immunodeficiency. (Pubmed Central) - Aug 14, 2021
Flexible dosing of IgPro20 (Hizentra®, CSL Behring, King of Prussia, Pennsylvania) maintains normal serum immunoglobulin G (IgG) levels in patients with primary immunodeficiencies (PID)...The GMR of dAUC was 1.07 (1.03-1.10). This PK analysis demonstrated similar systemic IgG exposure after weekly and biweekly IgPro20 dosing with an equivalent monthly dose in patients with PID.
- |||||||||| Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Trial suspension: Hizentra (clinicaltrials.gov) - Jul 6, 2021
P=N/A, N=100, Suspended,
Electrophysiology testing can support assessment of clinical status in CIDP to determine treatment efficacy. Not yet recruiting --> Suspended
- |||||||||| Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Trial completion date, Trial initiation date, Trial primary completion date: Hizentra (clinicaltrials.gov) - Apr 22, 2021
P=N/A, N=100, Not yet recruiting,
The identified drugs are feasible candidates for clinical trials among patients with persistent coxsackievirus B infections or chronic enterovirus-associated diseases. Trial completion date: Sep 2023 --> Sep 2024 | Initiation date: Mar 2021 --> Mar 2022 | Trial primary completion date: Sep 2023 --> Sep 2024
- |||||||||| Hizentra (human immune globulin subcutaneous 20%) / CSL Behring
Trial initiation date: Hizentra (clinicaltrials.gov) - Jan 14, 2021
P=N/A, N=100, Not yet recruiting,
Trial completion date: Sep 2023 --> Sep 2024 | Initiation date: Mar 2021 --> Mar 2022 | Trial primary completion date: Sep 2023 --> Sep 2024 Initiation date: Dec 2020 --> Mar 2021
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