Clinical trials: Primary Immunodeficiency Diseases (PID)
Primary Immunodeficiency (PID)
Gammanorm Quality of Life Study in Immunodeficient Patients Using Rapid Push or Pumps
The purpose of this study is to compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL according to the delivery device.
- Trial name
- NCT02180763
- Testing
- Gammanorm
- Where
- 8 sites in France
- Volunteers
- 31 people
- Sponsor
- Octapharma
Primary Immune Deficiency
Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy
The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).
- Trial name
- NCT00419341
- Testing
- Human Normal Immunoglobulin for Subcutaneous Administration
- Where
- 13 sites in United States
- Volunteers
- 49 people
- Sponsor
- CSL Behring
Agammaglobulinemia, IgG Deficiency
Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates.
- Conditions
- Agammaglobulinemia, IgG Deficiency, Common Variable Immunodeficiency
- Trial name
- NCT00322556
- Testing
- Immunoglobulins Intravenous (Human)
- Where
- 10 sites in United States
- Volunteers
- 55 people
- Sponsor
- CSL Behring
Primary Immunodeficiency, PID
Bilateral Orthotopic Lung Transplant - Bone Marrow Transplant
The purpose of this study is to determine whether bilateral orthotopic lung transplantation (BOLT) followed by cadaveric partially-matched CD3+/CD19+ depleted bone marrow transplant (BMT) is safe and effective for individuals…
- Trial name
- BOLT-BMT (NCT03330795)
- Testing
- CD3/CD19 neg allogeneic BMT
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Primary Immunodeficiency Diseases (PID), Immune Thrombocytopenic Purpura (ITP)
Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders
The purpose of this study is to assess the safety and efficacy of Immune Globulin Intravenous (Human), 10% (IGIV 10%) in subjects with primary immunodeficiency disorders.
- Conditions
- Primary Immunodeficiency Diseases (PID), Immune Thrombocytopenic Purpura (ITP), Kawasaki Syndrome
- Trial name
- NCT00157079
- Testing
- Immune Globulin Intravenous (Human), 10%
- Where
- 11 sites in United States
- Volunteers
- 61 people
- Sponsor
- Baxalta now part of Shire
Primary Immunodeficiency Diseases (PID)
A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases
The main aim of this study is to learn if TAK-881 is safe and well tolerated during long-term use in adults and children with PIDD who are eligible and completed study TAK-881-3001 (NCT05755035).
- Trial name
- NCT06076642
- Testing
- TAK-881, Koru 24 G HIgH Flo Subcutaneous Safety Needle Set (investigational in the US)
- Where
- 25 sites in United States, Czechia and 5 more
- Volunteers
- 53 people
- Sponsor
- Takeda
Primary Immune Deficiency Disorder
Study of Octanorm Subcutaneous IG in Patients With PID
This is an open-label phase III study with a 12-week wash-in/wash-out period followed by a 12-month efficacy period. The main goals of the study are to assess the efficacy of octanorm in preventing serious bacterial infections…
- Trial name
- NCT01888484
- Testing
- octanorm 16.5%
- Where
- 24 sites in United States, Canada and 5 more
- Volunteers
- 75 people
- Sponsor
- Octapharma
Fungal Infections, Primary Immune Deficiencies
Studies of Disorders With Increased Susceptibility to Fungal Infections
Background: Researchers are interested in studying disorders that make individuals more susceptible to fungal infections, specifically infections with the Candida yeast.
- Trial name
- NCT01222741
- Where
- United States
- Volunteers
- 850 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Primary Immune Deficiency
A Prospective Monocentric Study to Assess the Concordance of Lung MRI Compared to Chest CT Scan to Assess the Extent and Severity of Bronchial and Parenchymal Pulmonary Lesions in Adult Patients With Primary Immune Deficiency (PID) .
Currently, there is no official recommendations for the respiratory surveillance of patients with PID.However, it is recommended to perform a chest CT scan each 5 years or before any significant therapeutic change.
- Trial name
- IRMvsSCANNER (NCT05476653)
- Testing
- MRI procedure
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Hopital Foch
Primary Immunodeficiency
Diagnostic Immunization With Rabies Vaccine in Patients With PID
The purpose of this study is to evaluate diagnostic immunization protocol of rabies vaccine for diagnosis the patients with primary immunodeficiency disorders and study humoral and cellular immune response to rabies vaccine in…
- Trial name
- NCT02490956
- Testing
- Verorab® (PVRV; Purified Vero Cell Vaccine)
- Where
- Thailand
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Chulalongkorn University
Epstein-Barr Virus (EBV) Infections, Lymphoproliferative Disorders
Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies
The primary objective of this protocol is to provide expanded access to tabelecleucel to participants with Epstein-Barr virus-associated diseases and malignancies for whom there are no other appropriate therapeutic options, and…
- Conditions
- Epstein-Barr Virus (EBV) Infections, Lymphoproliferative Disorders, EBV+ Associated Lymphoma, EBV+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)
- Trial name
- NCT02822495
- Testing
- tabelecleucel
- Sponsor
- Atara Biotherapeutics
Primary Immunodeficiency (PID), Congenital Bone Marrow Failure Syndromes
Data Collection Study of Patients With Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT With RIC
This is a data collection study that will examine the general diagnostic and treatment data associated with the reduced-intensity chemotherapy-based regimen paired with simple alemtuzumab dosing strata designed to prevented graft…
- Conditions
- Primary Immunodeficiency (PID), Congenital Bone Marrow Failure Syndromes, Inherited Metabolic Disorders (IMD), Hereditary Anemias
- Trial name
- PRO-RIC (NCT04528355)
- Testing
- data collection
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Paul Szabolcs
Primary Immunodeficiency Diseases
A Study of NewGam, Human Immunoglobulin 10%, in Patients With Primary Immunodeficiency Diseases
The purpose of this study was to determine the efficacy of NewGam in preventing serious bacterial infections and to determine the pharmacokinetic profile of NewGam.
- Trial name
- NCT01012323
- Testing
- NewGam
- Where
- 7 sites in United States
- Volunteers
- 51 people
- Sponsor
- Octapharma
Primary Immunodeficiency Diseases (PID)
At-Home Subcutaneous Immunoglobulin Replacement Therapy Using Alexa Skill
The main aim of this study is to determine the impact of digital health technology, such as Alexa Skill, used to support the initiation of home-based subcutaneous immunoglobulin (SCIG) treatment, treatment management, and overall…
- Trial name
- NCT06150534
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Takeda
Primary Immunodeficiency Diseases
Developing a Screening Tool for Primary Immunodeficiency Disease (PID) in Pakistan
Case-control diagnostic accuracy study with 130 potential pediatric PID+ (primary immunodeficiency) patients, and 100 age-matched, healthy controls (PID-).
- Trial name
- NCT05758506
- Testing
- Primary Immunodeficiency (PID) Rapid Diagnostic Test (RDT)
- Where
- Pakistan
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- PATH
Primary Immunodeficiency Disease
Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID
This Phase III clinical study is to test efficacy, safety and pharmacokinetics of BT595 in treating patients with Primary Immunodeficiency (PID)
- Trial name
- NCT02810444
- Testing
- IgG Next Generation (BT595)
- Where
- 19 sites in United States, Germany and 3 more
- Volunteers
- 81 people
- Sponsor
- Biotest
Primary Immunodeficiency Diseases (PID)
Evaluation of Subcutaneous Immunoglobulin Product Cutaquig in Terms of Safety and Efficacy in the Treatment of Patients With Primary Immunodeficiencies
In the prospective part of the study, patients diagnosed with PID will receive replacement therapy with Cutaquig for at least 6 months and will be randomised with the help of physicians of the Russian PID Registry.
- Trial name
- NCT05986734
- Testing
- Cutaquig
- Where
- Russia
- Volunteers
- 100 people
- Sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Primary Immunodeficiency Disease
High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam)
This was a prospective, open-label, non-controlled, non-randomized multicenter Phase III study of 2 multiple-dose intravenous NewGam regimens (every 3 weeks or every 4 weeks, continuing the patient's infusion interval in the main…
- Trial name
- NGAM-05 (NCT01313507)
- Testing
- NewGam
- Where
- 6 sites in United States
- Volunteers
- 21 people
- Sponsor
- Octapharma
Agammaglobulinemia, IgG Deficiency
Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
The purpose of this study is to demonstrate the effect of IgPro10 on the prevention of serious bacterial infections in patients with primary immunodeficiency.
- Conditions
- Agammaglobulinemia, IgG Deficiency, Common Variable Immunodeficiency
- Trial name
- NCT00168025
- Testing
- Immunoglobulins Intravenous (Human)
- Volunteers
- 89 people
- Sponsor
- CSL Behring
Primary Immunodeficiency Diseases (PID)
Ex Vivo Evaluation of JAK-inhibitor and Gene Therapeutical Approach in JAK-STAT Related Disorders
The investigators want to study the JAK-inhibitors and their impact on the immune system and evaluate the potential of a gene-therapeutic strategy
- Trial name
- JAKarta (NCT07261891)
- Testing
- blood sampling
- Where
- Belgium
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- prof. dr. Rik Schrijvers