Hizentra: Clinical Trials

41 trials of Hizentra, newest first

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

24 completed, 7 recruiting, 5 terminated, 3 withdrawn. 19 Phase 3, 9 Phase 2, 7 Phase 4, 4 Phase 1, 2 Not applicable.

By phase and status

PhaseTrialsStatus
Phase 319Completed 13, Recruiting 3, Terminated 3
Phase 29Completed 7, Recruiting 1, Withdrawn 1
Phase 47Completed 4, Not yet recruiting 1, Recruiting 1, Withdrawn 1
Phase 14Completed 1, Recruiting 1, Terminated 1, Withdrawn 1
Not applicable2Completed 1, Unknown 1
Early Phase 11Terminated 1

Follow Hizentra: new trials by email Literature Review of Hizentra trials Research Report on Hizentra

Trials newest first · largest first

Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

TrialPhaseStatusSponsorEnrollmentStartUpdated
A Study of TAK-664 in People With Primary Immunodeficiency Diseases Who Have Not Yet Been Treated With Immunoglobulins
TAK-664 - Primary Immunodeficiency Diseases (PID)
Phase 4Not yet recruitingTakeda92026-11-012026-09-08
Single-arm Study of IgPro20 in Adults With Secondary Immune Deficiencies Due to Hematologic Malignancies Treated With B-cell Targeting Chimeric Antigen Receptor T-cell and T-cell Redirecting Therapies
IgPro20 - Secondary Immune Deficiency
Phase 3RecruitingCSL Behring632026-09-152026-10-14
A Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex in Participants With Secondary Antibody Deficiency Associated With Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma
Gamunex-C, 10% Injectable Solution - Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma
Phase 3RecruitingGrifols Biologicals, LLC492026-05-112026-10-01
A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Gamunex-C, Xembify - CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)
Phase 3RecruitingGrifols Therapeutics LLC402026-04-022026-10-09
Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia
IgPro20 - Multiple Myeloma, Hypogammaglobulinemia
Phase 2RecruitingMemorial Sloan Kettering Cancer Center1002025-05-082026-10-05
Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS
IgPro20, Placebo - Post-COVID Postural Orthostatic Tachycardia Syndrome
Phase 3TerminatedCSL Behring162024-08-282026-04-13
Usage of Spirometry in Managing IgG Therapy in CVID With Airway Disease
Hizentra - Common Variable Immunodeficiency
Phase 4RecruitingUniversity of Alabama at Birmingham222024-01-152026-05-04
IVIG vs SCIG in CIDP
Intravenous immune globulin G, Subcutaneous immune globulin G - CIDP, Immunoglobulin Deficiency
Phase 1RecruitingRutgers, The State University of New Jersey202022-09-112025-12-11
Immunoglobulin Replacement Therapy for Immunoglobulin G Subclass 2 Deficient Patients With Bronchiectasis
Cuvitru 20 % Injectable Solution - Bronchiectasis, Immunoglobulin Subclass Deficiency
Phase 4WithdrawnUniversity of Edinburgh2022-08-052021-09-29
Hizentra® in Inflammatory Neuropathies - pHeNIx Study
Hizentra - Chronic Inflammatory Demyelinating Polyneuropathy
RecruitingCSL Behring1002022-06-102025-01-07
Monotherapy IVIG Gamunex-C for HMG-CoA Reductase Auto-Antibody Positive Necrotizing Myopathy Treatment (The MIGHT Trial)
Gamunex-C, Albumin - Immune-Mediated Necrotizing Myopathy
Phase 2WithdrawnUniversity of Washington2022-05-012022-10-24
Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19)
GAMUNEX-C, Standard Medical Treatment - COVID-19
Phase 2CompletedGrifols Therapeutics LLC1002020-09-172022-10-07
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency
Gamunex-C, IVIG-PEG - Primary Immunodeficiency
Phase 3CompletedGrifols Therapeutics LLC332020-09-022023-06-05
Subcutaneous Immunoglobulin for Myasthenia Gravis
subcutaneous immunoglobulin (SCIG), intravenous immunoglobulin + subcutaneous immunoglobulin (SCIG) - Myasthenia Gravis
Phase 2CompletedUniversity Health Network, Toronto302020-08-282025-04-27
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)
human immunoglobulin G, Placebo - Dermatomyositis
Phase 3TerminatedCSL Behring1342019-10-212025-12-09
Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)
IgPro20, IgPro10 - Diffuse Cutaneous Systemic Sclerosis
Phase 2CompletedCSL Behring272019-09-192024-02-05
Humoral Immunodeficiency in CLL and Therapy With Subcutaneous Ig
Hizentra - Secondary Immune Deficiency Disorder
Phase 2 / Phase 3CompletedRochester General Hospital202018-11-052020-08-26
Real-world CANadian CUvitru Non-Interventional Study in Subjects Transitioning From Subcutaneous Immunoglobulin (CANCUN)
CUVITRU - Primary Immunodeficiency Diseases (PID)
CompletedBaxalta now part of Shire1262018-09-242021-03-05
Humoral Immunodeficiency With Rituximab and Therapy With Subcutaneous Ig
20% subcutaneous immunoglobulin - Secondary Immune Deficiency
Phase 2 / Phase 3CompletedRochester General Hospital162017-07-212021-04-19
Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects
HYQVIA, KIOVIG, Cuvitru - Primary Immunodeficiency Diseases (PID)
Phase 4CompletedBaxalta now part of Shire422017-05-302023-01-11

Showing 20 of 41. Sign in to see all of them.

Conditions studied

Primary Immunodeficiency Diseases (14)  ·  Polyradiculoneuropathy, Chronic Inflammatory Demyelinating (6)  ·  Myasthenia Gravis (4)  ·  Agammaglobulinemia (3)  ·  Common Variable Immunodeficiency (3)  ·  Leukemia, Lymphocytic, Chronic, B-Cell (3)  ·  Multiple Myeloma (3)  ·  Dermatomyositis (2)  ·  Lymphoma, Non-Hodgkin (2)  ·  Agammaglobulinemia, non-Bruton type (1)  ·  Biliary Atresia (1)  ·  Bronchiectasis (1)  ·  Bruton type agammaglobulinemia (1)  ·  Burkitt Lymphoma (1)  ·  COVID-19 (1)

Sponsors

CSL Behring (16)  ·  Grifols Therapeutics LLC (4)  ·  Baxalta now part of Shire (2)  ·  Rochester General Hospital (2)  ·  University of South Florida (2)  ·  Grifols Biologicals, LLC (1)  ·  Mayo Clinic (1)  ·  Mazen Dimachkie, MD (1)  ·  Memorial Sloan Kettering Cancer Center (1)  ·  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (1)  ·  Rutgers, The State University of New Jersey (1)  ·  St. Louis University (1)  ·  Takeda (1)  ·  Thomas Jefferson University (1)  ·  University Health Network, Toronto (1)

Countries

United States (27)  ·  Canada (11)  ·  France (8)  ·  United Kingdom (8)  ·  Germany (7)  ·  Poland (7)  ·  Italy (6)  ·  Japan (6)  ·  Spain (6)  ·  Czechia (5)  ·  Australia (3)  ·  Belgium (3)  ·  Romania (3)  ·  Sweden (3)  ·  Switzerland (3)

Top investigators

Adam T Hill, MBChB MD (1)  ·  Averell Sherker, MD (1)  ·  Balamurali K Ambati, M.D., Ph.D., M.B.A. (1)  ·  Ed Doo, MD (1)  ·  Elie Haddad, MD (1)  ·  Ghazala Hayat, M.D. (1)  ·  Hans Katzberg, MD (1)  ·  Harry Schroeder, MD/PhD (1)  ·  Jafar Kafaie, M.D. (1)  ·  James S Andrews, MD (1)  ·  John Sleasman, MD (1)  ·  Luigi Brunetti, PhD (1)  ·  Mazen M Dimachkie, MD (1)

Results publications

PMID 24412910, PMID 20454851, PMID 21553933, PMID 21674136, PMID 21705277, PMID 24504846, PMID 27342758, PMID 27455854, PMID 29122523, PMID 30664564, PMID 33025378, PMID 33409867, PMID 34653210, PMID 35934726, PMID 39289739, PMID 39909490, PMID 42578463

NIH funding

2016 (2), 2018 (2), 2023 (2), 2008 (1), 2015 (1), U01DK062456 (1)