Clinical trials: Primary Immunodeficiency Diseases (PID)
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 (PID), Congenital Bone Marrow Failure Syndromes
Reduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT
The objective of this study is to evaluate the efficacy of using a reduced-intensity condition (RIC) regimen with umbilical cord blood transplant (UCBT), double cord UCBT, matched unrelated donor (MUD) bone marrow transplant…
- Conditions
- Primary Immunodeficiency (PID), Congenital Bone Marrow Failure Syndromes, Inherited Metabolic Disorders (IMD), Hereditary Anemias
- Trial name
- HSCT+RIC (NCT01962415)
- Testing
- Hydroxyurea, Alemtuzumab, Fludarabine
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Paul Szabolcs
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 Immune Deficiency Disorder
Octagam 5% Versus Comparator Post Marketing Trial
Study Design: This is a 2 arm non-interventional trial that will compare the occurrence of adverse drug reactions between Octagam 5% and other marketed IVIG infusion treatments.
- Trial name
- NCT01859754
- Testing
- Octagam 5%, Other marketed IVIG product
- Where
- 27 sites in United States
- Volunteers
- 623 people
- Sponsor
- Octapharma
Severe Combined Immunodeficiency, T Cell Lymphocytopenia
Newborn Screening for Severe Combined Immunodeficiency (SCID) in a High-Risk Population
The goal of the proposed research is to establish the validity of a newborn screening method for severe combined immunodeficiency (SCID).
- Trial name
- NCT00845416
- Where
- 2 sites in United States
- Volunteers
- 1,800 people
- Sponsor
- University of California, San Francisco
Primary Immunodeficiency
The Benefit of 5% IVIG for Patients With Primary Immunodeficiency Disorders Who Experience Adverse Events on 10% IVIG Preparations
Patients with primary immunodeficiency disorders (PID) on intravenous immunoglobulin (IVIG) treatment may experience adverse events (AEs).
- Trial name
- NCT03339778
- Volunteers
- 15 people
- Sponsor
- IMMUNOe Research Centers
Primary Immunodeficiency
An Open-label, Multicenter Study to Assess the Pharmacokinetics (PK), Safety, and Tolerability of Subcutaneous IgPro20 in Immunoglobulin (IG) Treatment-naïve Participants With Primary Immunodeficiency (PID)
This is an open-label, multicenter, phase 4 study in IG treatment-naïve participants with PID, conducted in the United States (US), to assess the PK, safety, and tolerability of IgPro20.
- Trial name
- NCT07076446
- Testing
- IgPro
- Where
- 8 sites in United States
- Volunteers
- 8 people
- Sponsor
- CSL Behring
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)
Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID
The original purpose of the study is to assess the long-term safety, tolerability, and practicability of the subcutaneous (SC) treatment with Immune Globulin Subcutaneous Solution (IGSC), 10% facilitated with recombinant human…
- Trial name
- NCT01175213
- Testing
- SC treatment with IGSC, 10% with rHuPH20 followed by SC/IGSC, 10% only (safety), SC treatment with IGSC, 10% with rHuPH20 followed by IV/IGSC, 10% only (safety), IV treatment with IGSC, 10%
- Where
- 11 sites in United States
- Volunteers
- 66 people
- Sponsor
- Baxalta now part of Shire
Secondary or Primary Immunodeficiency
Tolerance and Patients' Satisfaction With IGHy
Primary immunodeficiencies (PID) represent more than 150 diseases affecting the immune system. More than 50% of PIDs are due to a lack or an insufficiency in antibody production.
- Trial name
- NCT03668288
- Testing
- Data record and questionnaires passation
- Where
- France
- Volunteers
- 20 people
- Sponsor
- CHU de Reims
Primary Immunodeficiency (PID), Secondary Immunodeficiency (SID)
Assessment of Immunoglobulins (IgG) in a Long-term Non-interventional Study
This non-interventional, epidemiological study assesses long-term outcomes in subjects receiving immunoglobulins (IgG) for any treatment purpose, irrespective of the regimen prescribed by the treating physician, under routine…
- Conditions
- Primary Immunodeficiency (PID), Secondary Immunodeficiency (SID), Neurological Autoimmune Disease
- Trial name
- SIGNS (NCT01287689)
- Testing
- Immunoglobulin G (IgG)
- Where
- 7 sites in Germany
- Volunteers
- 685 people
- Sponsor
- Technische Universität Dresden
Primary Immunodeficiency Diseases (PID)
A Database Survey to Evaluate the Safety of Immune Globulin Subcutaneous (Human), 20% Solution in Participants With Primary Immunodeficiency
This study is a retrospective database study in Japan to evaluate the safety of Immune Globulin Subcutaneous (Human), 20% Solution in participants with primary immunodeficiency disease (PID).
- Trial name
- NCT06565078
- Testing
- Immune Globulin Subcutaneous (Human), 20% Solution
- Where
- Japan
- Volunteers
- 100 people
- Sponsor
- Takeda
Primary Immunodeficiencies (PID), Secondary Immunodeficiencies (SID)
Assessing Patient Preference for Infusion Systems
This crossover study evaluates patient experiences and preferences between mechanical and electrical infusion pumps for subcutaneous immunoglobulin (SCIg) therapy.
- Trial name
- NCT07189013
- Testing
- Mechanical infusion pump
- Where
- United Kingdom
- Volunteers
- 52 people
- Sponsor
- KORU Medical Systems, Inc.
Immunodeficiencies, Primary Immunodeficiencies (PID)
V-IMMUNE: A Novel Immunoglobulin Therapy for Immunodeficiency
This is a phase III, non-randomized clinical trial (VIP Study) designed to assess the safety and efficacy of V-IMMUNE®, a 5% human normal immunoglobulin preparation, in approximately 50 patients with primary immunodeficiency…
- Conditions
- Immunodeficiencies, Primary Immunodeficiencies (PID), Agammaglobulinemia
- Trial name
- VIP (NCT06954441)
- Testing
- Intravenous immunoglobulin (IVIG)
- Where
- Brazil
- Volunteers
- 50 people
- Sponsor
- On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA.
Primary Immune Deficiency Disorder
A Study About Low Blood Pressure in Patients With Primary Immunodeficiency Disease Treated With Immune Globulin Products
This is a safety study to evaluate the risk of low blood pressure in subjects with Primary Immune Deficiency disorder (PID) treated with Bivigam™ or another commercial product under real world conditions.
- Trial name
- NCT03037359
- Testing
- Bivigam, Other
- Where
- 17 sites in United States
- Volunteers
- 200 people
- Sponsor
- ADMA Biologics, Inc.
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 Immune Deficiency
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
The objective of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics of a subcutaneous immune globulin (SCIG; IgPro20) in subjects with primary immunodeficiency (PID).
- Trial name
- NCT01199705
- Testing
- Immune Globulin Subcutaneous (Human) (SCIG)
- Where
- 10 sites in Japan
- Volunteers
- 25 people
- Sponsor
- CSL Behring
Primary Immunodeficiency Disease
Pediatric Primary Immunodeficiency Disease (PID) in China
This study is a prospective cohort study of children diagnosed with primary immunodeficiency disease (PID). The aim is to investigate the clinical characteristics and prognosis of PID in Chinese children.
- Trial name
- NCT03252548
- Volunteers
- 400 people
- Sponsor
- Beijing Children's Hospital
Primary Immunodeficiency Disease
Efficacy, Safety, and Pharmacokinetics of Shu Yang IVIG
To evaluate the safety, efficacy, and pharmacokinetic properties of Shu Yang intravenous immune globulin in patients with primary immune deficiency aged less than 60 years.
- Trial name
- Imunoforte (NCT06089122)
- Testing
- IVIG
- Volunteers
- 50 people
- Sponsor
- Azidus Brasil