Clinical trials: Hypogammaglobulinemia
Primary Immunodeficiency Disease
Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients
The purpose of this study was to assess efficacy and safety of Kedrion Immunoglobulin 10% (KIg10) in participants with Primary Immunodeficiency (PID).
- Trial name
- CARES10 (NCT03961009)
- Testing
- Kedrion IVIG 10%
- Where
- 11 sites in United States
- Volunteers
- 47 people
- Sponsor
- Kedrion S.p.A.
Primary Immune Deficiencies, Autoimmune Diseases
Investigation of Immune Disorders and Deficiencies
The immune system is an intricate system comprised of specialized cells, proteins, tissues and organs. Proper functioning is critical to the body's ability to defend itself against harmful pathogens.
- Conditions
- Primary Immune Deficiencies, Autoimmune Diseases, Inflammatory Diseases, Common Variable Immune Deficiencies
- Trial name
- NCT01981785
- Where
- United States
- Volunteers
- 343 people, healthy volunteers welcome
- Sponsor
- O & O Alpan LLC
Hypogammaglobulinemia, Acquired
Immunoglobulin for Hypogammaglobulinemia Due to Chimeric Antigen Receptor T Cell Therapy
Chimeric antigen receptor (CAR) T cells are special immune cells taken from a patient and changed in a lab to help them find and attack cancer cells.
- Trial name
- ICART (NCT06989541)
- Testing
- Immune Globulin Intravenous (Human), 10%, Immune Globulin Subcutaneous (Human), 20% Solution
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- University of Alberta
X-linked Agammaglobulinemia, XLA
COVID-19 Vaccine Responses in PIDD Subjects
The goal of our study is to assess the cellular immune responses of participants with antibody deficiency disease before and after immunization with SARS-CoV-2 mRNA vaccines.
- Conditions
- X-linked Agammaglobulinemia, XLA, Primary Immune Deficiency, CVID
- Trial name
- NCT05321407
- Where
- 3 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Duke University
Primary Immune Deficiency Disorders, Common Variable Immunodeficiency
Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases
The main objective of the study is to determine the pharmacokinetics profile of Subgam-VF. The secondary objectives are to assess the safety of Subgam-VF and refine the dose adjustment coefficient for Subgam-VF needed for…
- Conditions
- Primary Immune Deficiency Disorders, Common Variable Immunodeficiency, X-linked Agammaglobulinaemia, Hyperimmunoglobulin M Syndrome
- Trial name
- SCIG03 (NCT01884311)
- Testing
- Subgam
- Where
- 16 sites in United States
- Volunteers
- 38 people
- Sponsor
- Bio Products Laboratory
Agammaglobulinemia, BTK
Mutation of the BTK Gene and Genotype-phenotype Correlation of Chinese Patients With X-Linked Agammaglobulinemia
X-linked agammaglobulinemia (XLA) is a humoral primary immunodeficiency in which affected patients have very low levels of peripheral B cells and a profound deficiency of all immunoglobulin isotypes.
- Trial name
- NCT02234791
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Shanghai Children's Medical Center
Hypogammaglobulinemia, Lung Transplantation
Intravenous Immunoglobulin (IVIG) in Lung Transplantation
The purpose of this study is to determine if intravenous immunoglobulin (IVIG) can prevent bacterial infections in lung transplant patients with low serum levels of immunoglobulin.
- Trial name
- NCT00115778
- Testing
- IVIG
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Columbia University
Hypogammaglobulinemia, Autoimmune Conditions
Supporting Weak Immune System During Autoimmune Therapy: Testing Panzyga to Prevent Infections
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infection in Patients with Hypogammaglobulinemia and Autoimmune or Rheumatic…
- Conditions
- Hypogammaglobulinemia, Autoimmune Conditions, Rheumatic Conditions, Infections
- Trial name
- NCT07220915
- Testing
- Panzyga, 10% Intravenous Solution
- Where
- 25 sites in United States, Bulgaria and 5 more
- Volunteers
- 360 people
- Sponsor
- Octapharma
Chronic Lymphocytic Leukemia, Fatigue
Lenalidomide and Ofatumumab in Treating Participants With Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
This phase II trial studies how well lenalidomide and ofatumumab work in treating participants with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma.
- Conditions
- Chronic Lymphocytic Leukemia, Fatigue, Fever, Hypogammaglobulinemia
- Trial name
- NCT01002755
- Testing
- Lenalidomide, Ofatumumab
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- M.D. Anderson Cancer Center
Immunologic Deficiency Syndrome, Agammaglobulinemia
Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients
The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% caprylate/chromatography (IGIV-C)purified is similar when infused at two different infusion rates.
- Conditions
- Immunologic Deficiency Syndrome, Agammaglobulinemia, Severe Combined Immunodeficiency, Wiskott-Aldrich Syndrome
- Trial name
- NCT00220766
- Testing
- Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified, Dextrose, 5% in Water
- Where
- 13 sites in United States, Canada
- Volunteers
- 100 people
- Sponsor
- Grifols Therapeutics LLC
Primary Immune Deficiency Disorders, Common Variable Immunodeficiency
Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases
The primary objective is to demonstrate the bioequivalence of Gammaplex® 10 intravenous immunoglobulin (IGIV) and Gammaplex® 5% IGIV with respect to area under the curve within a 28-day dosing interval (AUC0-28) in a cohort of…
- Conditions
- Primary Immune Deficiency Disorders, Common Variable Immunodeficiency, X-linked Agammaglobulinaemia, Hyper-IgM Syndrome
- Trial name
- GMX07 (NCT01963143)
- Testing
- Gammaplex (5%), Gammaplex 10
- Where
- 17 sites in United States, Hungary and 1 more
- Volunteers
- 48 people
- Sponsor
- Bio Products Laboratory
Multiple Myeloma, Hypogammaglobulinemia
Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia
The main purpose of this study is to see if IgPro20 can prevent infection in people with multiple myeloma (MM) who have hypogammaglobulinemia from receiving bispecific monoclonal antibodies (BsAbs).
- Conditions
- Multiple Myeloma, Hypogammaglobulinemia, Hypogammaglobulinemia, Acquired
- Trial name
- NCT06976476
- Testing
- IgPro20
- Where
- 9 sites in United States
- Volunteers
- 100 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Leukopenia, Neutropenia
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
Background: WHIMS (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis Syndrome) is caused by various genetic changes that increase the activity of the chemokine receptor, CXCR4.
- Conditions
- Leukopenia, Neutropenia, Infections, Warts
- Trial name
- NCT00967785
- Testing
- Mozobil (TM)
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Immunologic Deficiency Syndromes
A Clinical Study of Intravenous Immunoglobulin
The purpose of this study is to measure the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human) [IGIV], 5% Solution Omr-IgG-am™ in patients with primary immunodeficiency diseases.
- Trial name
- IGIV (NCT00468273)
- Testing
- Immune Globulin Intravenous (Human) Omr-IgG-am IGIV
- Where
- 10 sites in United States, Canada
- Volunteers
- 57 people
- Sponsor
- FFF Enterprises
Immune Deficiency Disorders, Severe Combined Immunodeficiency
Immune Disorder HSCT Protocol
This study hypothesizes that a reduced intensity immunosuppressive preparative regimen will establish engraftment of donor hematopoietic cells with acceptable early and delayed toxicity in patients with immune function disorders.
- Conditions
- Immune Deficiency Disorders, Severe Combined Immunodeficiency, Chronic Granulomatous Disease, X-linked Agammaglobulinemia
- Trial name
- NCT01821781
- Testing
- Transplant preparative regimen of alemtuzumab, fludarabine, thiotepa, and melphalan
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Washington University School of Medicine
Hypogammaglobulinemia
Kinetics, Efficacy and Safety of IVIG-L in Hypogammaglobulinemia Patients
The kinetics, efficacy and safety of a liquid intravenous immunoglobulin product, IVIG-L, were studied in patients with hypogammaglobulinemia, who are regularly treated with intravenous immunoglobulin substitution therapy.
- Trial name
- NCT00138697
- Testing
- IVIG-L
- Where
- 6 sites in Netherlands
- Volunteers
- 15 people
- Sponsor
- Prothya Biosolutions
CIDP, Immunoglobulin Deficiency
IVIG vs SCIG in CIDP
Current dosing practices for immunoglobulin G (IgG) may be inadequate in extreme body weight. The current study will evaluate the influence of body composition on intravenous and subcutaneous administration of immunoglobulin G in…
- Conditions
- CIDP, Immunoglobulin Deficiency, Chronic Inflammatory Demyelinating Polyneuropathy
- Trial name
- NCT05584631
- Testing
- Intravenous immune globulin G, Subcutaneous immune globulin G
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Rutgers, The State University of New Jersey