Clinical trials: Primary Antibody Deficiency, active
Primary Immune Deficiency
Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Immunoglobulin (Newnorm) in Patients With Primary Immunodeficiency Diseases
Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, efficacy, tolerability, and safety of subcutaneous human immunoglobulin (Newnorm) in patients with primary immunodeficiency diseases
- Trial name
- NCT04640142
- Testing
- Newnorm
- Where
- 23 sites in United States, Germany and 5 more
- Volunteers
- 50 people
- Sponsor
- Octapharma
Primary Antibody Deficiency Disorders
Exercise Intervention and Immunodeficiency
The purpose of this study is to assess if a 12-week exercise program is safe, practical, and acceptable for adults with primary antibody deficiencies.
- Trial name
- NCT07698197
- Testing
- App-based exercise intervention
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Yale University
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 Immunodeficiency Diseases (PID)
Efficacy, Safety and Pharmacokinetic of Virchow IVIG in PID Patients
The study duration for individual patients will be up to 55 weeks for the 4-weekly and 3- weekly schedule of the treatment which includes 3 weeks for screening, 48 weeks for Study Medication administration and 4 weeks for…
- Trial name
- VBPL-IVIGP3 (NCT07017036)
- Testing
- IVIG-VImmune, IVIG-Immuglo
- Where
- 2 sites in India
- Volunteers
- 44 people
- Sponsor
- Virchow Group
Primary Immune Deficiency
Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency
The purpose of this study is to evaluate the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects with Primary Humoral Immunodeficiency (PHID).
- Trial name
- NCT04565015
- Testing
- GC5107
- Where
- 8 sites in United States, Bosnia and Herzegovina and 1 more
- Volunteers
- 24 people
- Sponsor
- GC Biopharma Corp
Bronchiectasis, Cystic Fibrosis
Natural History of Bronchiectasis
Bronchiectasis is a chronic inflammatory and muco-obstructive condition that results in abnormal dilation of the airways, decline in lung function, frequent exacerbations, and chronic respiratory tract infections.
- Conditions
- Bronchiectasis, Cystic Fibrosis, Autoimmune Disease, Common Variable Immunodeficiency
- Trial name
- NCT00943514
- Where
- United States
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
HIV/AIDS and Infections
Phase II Trial of ART + Dual bNAbs vs. ART + Placebo During Primary HIV-1 Infection-impact on Post-ART Control
RHIVIERA-02 trial is a placebo-controlled double-blinded two arm prospective phase II trial. This study will test the use of broadly neutralising antibodies (bNAbs) in participants, at primary HIV infection (PHI) and ART…
- Trial name
- RHIVIERA-02 (NCT05300035)
- Testing
- Recombinant human monoclonal antibody (bNAbs)
- Where
- 17 sites in France
- Volunteers
- 69 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Common Variable Immunodeficiency (CVID), Primary Immune Regulatory Disorder
Hematopoietic Stem Cell Transplantation (HSCT) for Common Variable Immunodeficiency (CVID) and Other Autoimmune Manifestations of Primary Immune Regulatory Disorders (PIRD)
This is a research protocol that will examine Hematopoietic Stem Cell Transplantation (HSCT) using a reduced conditioning regimen (RIC) with total body Irradiation (TBI) in those diagnosed with Common Variable Immunodeficiency…
- Conditions
- Common Variable Immunodeficiency (CVID), Primary Immune Regulatory Disorder, Immune Dysregulation, DiGeorge Syndrome
- Trial name
- CVID/PIRD (NCT07284641)
- Testing
- Hematopoietic stem cell transplant (HSCT)
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Paul Szabolcs
Primary Immunodeficiency Disease
Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients (KIDCARES10)
The purpose of this study is to assess efficacy, safety and pharmacokinetics of Kedrion Immunoglobulin 10% (KIg10) in pediatric patients with Primary Immunodeficiency Disease (PID).
- Trial name
- KIDCARES10 (NCT04944979)
- Testing
- Kedrion IVIG 10%
- Where
- 21 sites in United States, Hungary and 4 more
- Volunteers
- 30 people
- Sponsor
- Kedrion S.p.A.
Lymphoproliferative Disorders, Autoimmune Lymphoproliferative
Allogeneic Hematopoietic Stem Cell Transplant for Patients With Inborn Errors of Immunity
Background: During a transplant, blood stem cells from one person are given to someone else. The cells grow into the different cells that make up the immune system. This can cure people with certain immunodeficiencies.
- Conditions
- Lymphoproliferative Disorders, Autoimmune Lymphoproliferative, Immune System Diseases, Common Variable Immunodeficiency
- Trial name
- NCT04339777
- Testing
- Busulfan test dose, Fludarabine, Busulfan
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- National Cancer Institute (NCI)
Immunodeficiency Common Variable
Phase 2 and 3 Placebo Controlled & Long-term Extension Study of Rilzabrutinib in Adults With iCVID to Evaluate Efficacy, Safety, and Tolerability
This is a 4-part study where both Part A and Part B, which starts after the completion of Part A, are randomized (2:1), double-blinded, placebo-controlled studies, followed by an open label (Part C) and long-term extension period…
- Trial name
- NCT07923305
- Testing
- rilzabrutinib
- Volunteers
- 96 people
- Sponsor
- Sanofi
SCID, Omenn's Syndrome
Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies
This is a standard of care treatment guideline for allogeneic hematopoetic stem cell transplant (HSCT) in patients with primary immune deficiencies.
- Conditions
- SCID, Omenn's Syndrome, Reticular Dysgenesis, Wiskott-Aldrich Syndrome
- Trial name
- NCT01652092
- Testing
- Alemtuzumab 0.3 mg, Cyclophosphamide, Busulfan
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
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
Primary T-cell Immunodeficiency Disorders, Common Variable Immunodeficiency
Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies
Background: Allogeneic blood or marrow transplant is when stem cells are taken from one person s blood or bone marrow and given to another person. Researchers think this may help people with immune system problems.
- Conditions
- Primary T-cell Immunodeficiency Disorders, Common Variable Immunodeficiency, Immune System Diseases, Autoimmune Lymphoproliferative
- Trial name
- NCT02579967
- Testing
- Immunosuppression Only Conditioning -Closed with amendment L, Reduced Intensity Conditioning, Myeloablative Conditioning-Closed with amendment L
- Where
- 2 sites in United States
- Volunteers
- 354 people, healthy volunteers welcome
- Sponsor
- National Cancer Institute (NCI)
Adenine Phosphoribosyltransferase Deficiency, AH Amyloidosis
National Registry of Rare Kidney Diseases
The goal of this National Registry is to is to collect information from patients with rare kidney diseases, so that it that can be used for research.
- Conditions
- Adenine Phosphoribosyltransferase Deficiency, AH Amyloidosis, AHL Amyloidosis, AL Amyloidosis
- Trial name
- RaDaR (NCT06065852)
- Where
- United Kingdom
- Volunteers
- 35,000 people
- Sponsor
- UK Kidney Association
Primary Immunodeficiency Diseases (PID)
A Study of TAK-664 in People With Primary Immunodeficiency Diseases Who Have Not Yet Been Treated With Immunoglobulins
Primary immunodeficiency disease (or PIDD) is a group of conditions in which the immune system does not work properly. Some people with PIDD do not make enough antibodies.
- Trial name
- NCT07794735
- Testing
- TAK-664
- Volunteers
- 9 people
- Sponsor
- Takeda
Primary Immunodeficiency Diseases
Study of BP-SCIG 20% in Patients With Primary Immunodeficiency (PID)
All patients will receive the investigational medicinal product BP-SCIG 20%, solution for subcutaneous administration, manufactured by BIOPHARMA PLASMA LLC.
- Trial name
- NCT07346859
- Testing
- BP-SCIG 20%
- Where
- 12 sites in Ukraine
- Volunteers
- 56 people
- Sponsor
- Biopharma Plasma LLC
Primary Immunodeficiency, DOCK8
Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders
Background: National Institutes of Health (NIH) researchers have been studying immune cells (white blood cells) to better understand how the human body s defense system works and adjusts or regulates itself, and how changes in…
- Conditions
- Primary Immunodeficiency, DOCK8, Virus Susceptibility
- Trial name
- NCT00895271
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Lymphoproliferative Disorders, Autoimmune Lymphoproliferative
Allogeneic Hematopoietic Cell Transplantation for Disorders of T-cell Proliferation and/or Dysregulation
Background: Blood stem cells in the bone marrow make all the cells to normally defend a body against disease. Allogeneic blood or marrow transplant is when these stem cells are transferred from one person to another.
- Conditions
- Lymphoproliferative Disorders, Autoimmune Lymphoproliferative, Primary T-cell Immunodeficiency Disorders, Immune System Diseases
- Trial name
- NCT03663933
- Testing
- e-ATG, Immunosuppression Only Conditioning, Reduced Intensity Conditioning
- Where
- 2 sites in United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- National Cancer Institute (NCI)
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