Clinical trials: Primary Immunodeficiencies (PID)
Primary Immunodeficiency Diseases (PID)
Gammagard Liquid and rHuPH20 in PID
The purpose of the study is to develop a subcutaneous treatment option for participants with Primary Immunodeficiency Diseases (PID) that allows an administration of Immune Globulin Intravenous (Human), 10% at the same frequency…
- Trial name
- NCT00814320
- Testing
- Recombinant human hyaluronidase (rHuPH20)+ immune globulin intravenous (IGIV)
- Where
- 14 sites in United States, Canada
- Volunteers
- 89 people
- Sponsor
- Baxalta now part of Shire
Primary Immunodeficiency Diseases (PID)
A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID)
In this study, Japanese participants with primary immunodeficiency diseases were treated with Immune Globulin Subcutaneous (Human), 20% solution, (IGSC, 20%).
- Trial name
- NCT04346108
- Testing
- Immune Globulin Intravenous (IGIV), Immune Globulin Subcutaneous, 20% Solution (IGSC, 20%)
- Where
- 8 sites in Japan
- Volunteers
- 17 people
- Sponsor
- Baxalta now part of Shire
Primary Immunodeficiency Diseases (PID)
Phase 2/3 Study of IGSC, 20% in PIDD
The purpose of this study is to develop a 20% subcutaneous (SC) immunoglobulin preparation for the treatment of patients with primary immunodeficiency diseases (PIDD).
- Trial name
- NCT01218438
- Testing
- Immune Globulin Intravenous (Human), 10% Solution, Immune Globulin Subcutaneous (Human), 20% Solution
- Where
- 18 sites in United States, Canada
- Volunteers
- 86 people
- Sponsor
- Baxalta now part of Shire
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
Primary Immune Deficiency Disorders, Common Variable Immunodeficiency
A Study to Find Out How Safe and Effective Gammaplex® is in Young People With Primary Immunodeficiency
The main objective is to determine the efficacy of Gammaplex by measuring the number of serious acute bacterial infections during treatment with Gammaplex over a 12 month period.
- Conditions
- Primary Immune Deficiency Disorders, Common Variable Immunodeficiency, X-linked Agammaglobulinemia, Hyper-IgM Syndrome
- Trial name
- NCT01289847
- Testing
- Gammaplex
- Where
- 10 sites in United States, Chile and 1 more
- Volunteers
- 25 people
- Sponsor
- Bio Products Laboratory
Primary Immunodeficiency Diseases (PID)
Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD
The purpose of the study is to acquire additional data on safety and tolerability of recombinant human hyaluronidase (rHuPH20) facilitated subcutaneous treatment of Immune Globulin Infusion (Human), 10% (IGI, 10%) and to assess…
- Trial name
- NCT01485796
- Testing
- Immune Globulin Infusion (Human), 10%, Recombinant human hyaluronidase
- Where
- 10 sites in United States
- Volunteers
- 54 people
- Sponsor
- Baxalta now part of Shire
Primary Immunodeficiency
Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary Immunodeficiency (PID)
This multicenter, open-label, parallel-arm, non-randomized study is designed to evaluate safety and tolerability of higher infusion parameters of IgPro20 in subjects with primary immunodeficiency (PID).
- Trial name
- NCT03033745
- Testing
- IgPro20
- Where
- 12 sites in United States, Canada
- Volunteers
- 49 people
- Sponsor
- CSL Behring
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 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 Diseases (PID)
A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PID) Participants
The main aim of the study is to check side effect from the study treatment with TAK-771 in long term. Participants can have taken part in the previous study TAK-771-3004 (NCT05150340).
- Trial name
- NCT05513586
- Testing
- TAK-771
- Where
- 9 sites in Japan
- Volunteers
- 15 people
- Sponsor
- Takeda
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
Primary Immune Deficiency Disorder, Hematopoietic Stem Cell Transplantation
TCR Alpha/Beta Depletion for HSCT From Haploidentical and Unrelated Donors in the Treatment of PID
Treatment Study to assess of safety and efficiency of T cells receptor (TCR) alfa beta depleted graft for hematopoietic stem cell transplantation (HSCT) from haploidentical and unrelated donors in patients with primary…
- Trial name
- NCT02327351
- Testing
- Biological: TCR alfa beta T cell depletion
- Where
- Russia
- Volunteers
- 98 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
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, Agammaglobulinemia
Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)
The purpose of this study is to determine whether Kedrion IVIG 10% (an immunoglobulin solution) is effective in treating Primary Immunodeficiency (PID).
- Conditions
- Primary Immunodeficiency, Agammaglobulinemia, Hypogammaglobulinemia, Antibody Deficiency
- Trial name
- NCT01581593
- Testing
- Kedrion IVIG 10%
- Where
- 15 sites in United States, Canada
- Volunteers
- 45 people
- Sponsor
- Kedrion S.p.A.
Common Variable Immunodeficiency, Agammaglobulinemia
Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary Immunodeficiency
The objective of this study is to assess the efficacy and safety of Vivaglobin in previously untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation period.
- Trial name
- NCT00520494
- Testing
- Vivaglobin
- Where
- 6 sites in Canada, Germany and 2 more
- Volunteers
- 18 people
- Sponsor
- CSL Behring
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 Immune Deficiency Disorders (PIDD)
Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)
The purpose of this study is to determine if NABI-IGIV (10%) [Immune Globulin Intravenous (Human), 10%] is safe and effective in preventing serious bacterial infections (SBIs) in the treatment of patients with primary immune…
- Trial name
- NCT00538915
- Testing
- Nabi-IGIV 10% [Immune Globulin Intravenous (Human). 10%]
- Where
- 17 sites in United States
- Volunteers
- 63 people
- Sponsor
- ADMA Biologics, Inc.
Primary Immunodeficiency Diseases (PID)
A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases
The main aim of this study is to evaluate the PK, safety, tolerability and immunogenicity of subcutaneous (SC) administration of TAK-881 in adult and pediatric participants with PIDD and compare them to HYQVIA in participants 16…
- Trial name
- NCT05755035
- Testing
- TAK-881, HYQVIA
- Where
- 32 sites in United States, Czechia and 6 more
- Volunteers
- 65 people
- Sponsor
- Takeda
Primary Immune Deficiency
Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID)
The purpose of this study is to determine whether a long-term use of a new human immunoglobulin G with proline (IgPro) is safe and effective in the treatment of primary immunodeficiency.
- Trial name
- NCT00719680
- Testing
- IgPro20
- Where
- 4 sites in United States
- Volunteers
- 21 people
- Sponsor
- CSL Behring