CLINICAL TRIALS PROFILE FOR HIZENTRA

All Clinical Trials for HIZENTRA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01354587 ↗	Evaluation of Efficacy and Tolerability of Hizentra®	Unknown status	University of South Florida	N/A	2010-10-01	The purpose of this study is to measure the changes in the Treatment Satisfaction Questionnaire for Medication in the areas of effectiveness, side effects, and convenience of administration of each medication in Primary Immunodeficiency Disorder (PIDD) subjects transitioning from subcutaneous Vivaglobin® to Hizentra®.
NCT01828294 ↗	Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis	Terminated	CSL Behring	Phase 1	2011-10-01	The study is being done with patients with Myasthenia Gravis (MG), age 18-80 years, positive acetylcholine receptor antibody, receiving greater than 30mg of prednisone daily. Patients may or may not be receiving anticholinesterase agents. A common treatment for patients with this disease includes the administration of intravenous immunoglobulin (IVIG), which is a plasma protein that is given to help maintain adequate antibody levels to prevent infections and decrease the symptoms of the disease of Myasthenia Gravis. This study is being done to test if giving this medication in a subcutaneous form (into the fat of the abdomen, legs and thighs) will be better tolerated for patients with Myasthenia Gravis.
NCT01828294 ↗	Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis	Terminated	St. Louis University	Phase 1	2011-10-01	The study is being done with patients with Myasthenia Gravis (MG), age 18-80 years, positive acetylcholine receptor antibody, receiving greater than 30mg of prednisone daily. Patients may or may not be receiving anticholinesterase agents. A common treatment for patients with this disease includes the administration of intravenous immunoglobulin (IVIG), which is a plasma protein that is given to help maintain adequate antibody levels to prevent infections and decrease the symptoms of the disease of Myasthenia Gravis. This study is being done to test if giving this medication in a subcutaneous form (into the fat of the abdomen, legs and thighs) will be better tolerated for patients with Myasthenia Gravis.
NCT02100969 ↗	Open Label Study of Subcutaneous Immunoglobulin (SCIg) in Myasthenia Gravis	Completed	CSL Behring	Phase 2	2015-05-01	The purpose of this study is to determine whether Hizentra is a safe and effective treatment for people with myasthenia gravis (MG).
NCT02100969 ↗	Open Label Study of Subcutaneous Immunoglobulin (SCIg) in Myasthenia Gravis	Completed	Mazen Dimachkie, MD	Phase 2	2015-05-01	The purpose of this study is to determine whether Hizentra is a safe and effective treatment for people with myasthenia gravis (MG).
NCT02111590 ↗	Immunoglobulin Dosage and Administration Form in CIDP and MMN	Completed	Aarhus University Hospital		2014-01-01	The aim of this study is to evaluate development of hemolysis and the variation in isokinetic muscle strength in two groups of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) or multifocal motor neuropathy (MMN) 1. Patients shifted from 3- or 6-weekly treatment with intravenous immunoglobulin (IVIG) to weekly treatment with subcutanoeus immunoglobulin (SCIG) 2. Patients shifted from SCIG treatment with Subcuvia® or Hizentra® to Gammanorm®. Hypotheses - During treatment with IVIG blood hemoglobin will fluctuate with a decline due to infusion, whereas it will remain stable during SCIG treatment without fluctuation - Isokinetic muscle strength in affected muscle groups is more stable during treatment with SCIG than with IVIG - Blood hemoglobin and changes in muscle strength is comparable during Subcuvia® or Hizentra® and Gammanorm® treatment

Clinical Trial Conditions for HIZENTRA

Condition Name

Condition Name for HIZENTRA
Intervention	Trials
Myasthenia Gravis	3
Chronic Inflammatory Demyelinating Polyneuropathy	2
Dermatomyositis	2
Primary Immunodeficiency Disorders	1

Condition MeSH

Condition MeSH for HIZENTRA
Intervention	Trials
Immunologic Deficiency Syndromes	3
Myasthenia Gravis	3
Primary Immunodeficiency Diseases	2
Polyneuropathies	2

Clinical Trial Locations for HIZENTRA

Trials by Country

Trials by Country for HIZENTRA
Location	Trials
United States	29
Japan	7
Canada	6
Mexico	3
Poland	1

Trials by US State

Trials by US State for HIZENTRA
Location	Trials
New York	4
Florida	4
Arizona	3
Pennsylvania	2
Texas	2

Clinical Trial Progress for HIZENTRA

Clinical Trial Phase

Clinical Trial Phase for HIZENTRA
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for HIZENTRA
Clinical Trial Phase	Trials
Completed	6
Terminated	2
Unknown status	2

Clinical Trial Sponsors for HIZENTRA

Sponsor Name

Sponsor Name for HIZENTRA
Sponsor	Trials
CSL Behring	7
University of South Florida	2
University Health Network, Toronto	1

Sponsor Type

Sponsor Type for HIZENTRA
Sponsor	Trials
Other	12
Industry	7