Clinical trials: Primary Immunodeficiency (PID)
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 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 (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
Epstein-Barr Virus (EBV)-Associated Diseases, EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (EBV+ PID LPD)
A Study to Evaluate Tabelecleucel in Participants With Epstein Barr Virus (EBV) Associated Diseases
The purpose of this study is to assess the efficacy and safety of tabelecleucel in participants with EBV-associated diseases.
- Conditions
- Epstein-Barr Virus (EBV)-Associated Diseases, EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (EBV+ PID LPD), EBV+ Lymphoproliferative Disease With Acquired (Non-congenital) Immunodeficiency (EBV+ AID LPD), EBV+ Posttransplant Lymphoproliferative Disease in Central Nervous System (EBV+ CNS PTLD)
- Trial name
- NCT04554914
- Testing
- Tabelecleucel
- Where
- 40 sites in United States, Austria and 5 more
- Volunteers
- 190 people
- Sponsor
- Pierre Fabre Medicament
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)
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 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.
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 (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 Immunodeficiency Diseases (PID)
A Study of TAK-771 in Japanese People With Primary Immunodeficiency Diseases (PID)
The main aim of the study is to check how much TAK-771 stays in their blood over time, side effect from the study treatment or TAK-771, how much TAK-771 participants can receive without getting side effects from it, and if…
- Trial name
- NCT05150340
- Testing
- TAK-771
- Where
- 12 sites in Japan
- Volunteers
- 16 people
- Sponsor
- Takeda
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)
Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric PIDD Subjects
The purpose of the study is to acquire additional data on efficacy, safety, tolerability, immunogenicity, pharmacokinetic (PK) and other parameters of HYQVIA in pediatric (age ≥ 2 to <16 years) participants with primary…
- Trial name
- NCT03277313
- Testing
- HYQVIA
- Where
- 19 sites in United States
- Volunteers
- 44 people
- Sponsor
- Baxalta now part of Shire
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 Diseases (PID)
Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects
The purpose of the study is to acquire additional data on safety, tolerability and immunogenicity of HyQvia in pediatric (age two to <18 years) patients with Primary Immunodeficiency Diseases (PIDD)
- Trial name
- NCT03116347
- Testing
- HYQVIA, KIOVIG, Cuvitru
- Where
- 20 sites in Czechia, Denmark and 6 more
- Volunteers
- 42 people
- Sponsor
- Baxalta now part of Shire
Primary Immunodeficiency Diseases (PID)
Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)
The purpose of the proposed study is to acquire additional data (including the assessment of anti-rHuPH20 antibodies) on the long-term safety of HYQVIA and to assess the prescribed treatment regimens and treatment administration…
- Trial name
- NCT02593188
- Testing
- HYQVIA
- Where
- 30 sites in United States
- Volunteers
- 264 people
- Sponsor
- Baxalta now part of Shire
Primary Immunodeficiencies (PID)
Retrospective, Observational Chart Review Study Conducted in Poland to Document the Management and Clinical Outcome of CUVITRU and HYQVIA in Pediatric Participants (< 18 Years) With Primary Immunodeficiency (PID)
The purpose of this observational, multi-center, retrospective cohort study is to assess treatment patterns of Cuvitru (SCIG) 20 percent (%) and HyQvia (fSCIG) in polish pediatric participants with PID.
- Trial name
- IG-TATRY (NCT04636502)
- Where
- 5 sites in Poland
- Volunteers
- 96 people
- Sponsor
- Shire
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), Agammaglobulinemia
Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)
The purpose of this study is to determine the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution in subjects with primary immunodeficiency (PID) manifesting as…
- Conditions
- Primary Immunodeficiency Diseases (PID), Agammaglobulinemia, Hypogammaglobulinemia
- Trial name
- NCT00161993
- Testing
- Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution, Gammagard S/D (Solvent/Detergent)
- Where
- 6 sites in Finland, Sweden
- Volunteers
- 24 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 Immunodeficiency Diseases (PID)
Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in Primary Immunodeficiency (PID) Subjects
The purpose of this study is to evaluate the tolerability of IGIV, 10% given subcutaneously and the pharmacokinetics of immunoglobulin G (IgG) following subcutaneous (SC) treatment with IGIV, 10% in subjects with primary…
- Trial name
- NCT00546871
- Testing
- Immune Globulin Intravenous (Human), 10%
- Where
- 9 sites in United States
- Volunteers
- 49 people
- Sponsor
- Baxalta now part of Shire