Clinical trials: Immunoglobulin Deficiency
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
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
Ornithine Transcarbamylase Deficiency, Wilson Disease
Adeno-Associated Virus (AAV) Antibody Study in Subjects OTC Deficiency, GSDIa, and Wilson Disease
The objective of this observational study is to evaluate the seroprevalence of anti-AAV antibodies in subjects with Ornithine Transcarbamylase (OTC) deficiency, Glycogen Storage Disease Type Ia (GSDIa), and Wilson Disease
- Conditions
- Ornithine Transcarbamylase Deficiency, Wilson Disease, Glycogen Storage Disease Type IA
- Trial name
- NCT04909346
- Where
- 5 sites in United States, Brazil and 3 more
- Volunteers
- 51 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Advanced Solid Tumor, Homologous Recombination Deficiency
EIS-12656 as Single Agent and in Combination in Patients With Specified Solid Tumors
This trial investigates a new drug, EIS-12656, in participants with specified advanced solid tumors carrying pre-specified mutations. The trial consists of a dose escalation part (Phase 1) and a dose expansion part (Phase 2).
- Conditions
- Advanced Solid Tumor, Homologous Recombination Deficiency, HRR Deficiency
- Trial name
- NCT06525298
- Testing
- EIS-12656, Olaparib, Trastuzumab deruxtecan
- Where
- United States
- Volunteers
- 144 people
- Sponsor
- Eisbach Bio GmbH
Primary Immunodeficiency
Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10%
Phase 3 multicenter, open-label study of safety, tolerability, efficacy, and pharmacokinetics (PK) of ProMetic's Immune Globulin Intravenous (Human) 10%, the investigational medicinal product [IMP]), in Adults and Children with…
- Trial name
- NCT02269163
- Testing
- Immune Globulin Intravenous, Prometic's Immune Globulin Intravenous 10%
- Where
- 13 sites in United States
- Volunteers
- 82 people
- Sponsor
- Prometic Biotherapeutics, Inc.
Generalized Lipodystrophy
A Study of the Safety of Mibavademab in Pediatric and Adult Participants Switching From Metreleptin to Mibavademab for the Treatment of Generalized Lipodystrophy (GLD)
This study is researching an experimental drug called mibavademab. The study is focused on participants with GLD who have been on metreleptin treatment for at least 6 months with no change in dose for the last 3 months.
- Trial name
- NCT06548100
- Testing
- mibavademab
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Regeneron Pharmaceuticals
Secondary Immune Deficiency
The Effect of Subcutaneous Immunoglobulin Gammanorm on the Distribution of IgG Subclasses and on Immunity of Patients With Secondary Immunodeficiency
Patients with Myeloma or CLL with severe secondary hypogammaglobinemia and recurrent infections will be included in this study; for whom an IgSC treatment was prescribed.
- Trial name
- NCT03369301
- Testing
- Gammanorm, Other Subcutaneous Immunoglobulins
- Where
- 6 sites in France
- Volunteers
- 102 people
- Sponsor
- Octapharma
Primary Immunodeficiency Disease (PIDD)
Monitoring of 5% Treatment Naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) Patients Using the CareExchange® System: A Pilot Study Using 5% Gammaplex® IVIg in the Home Setting
The purpose of this study is to demonstrate the utility of measuring outcomes in 5% treatment naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) patients using infusion nurse and patient measured…
- Trial name
- NCT02176239
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- BriovaRx Infusion Services
Cryptosporidiosis, HIV Infections
The Effectiveness of Cow's Milk Immune Globulin in the Treatment of AIDS-Related Diarrhea
To examine the efficacy of cow's milk immune globulin in the treatment of diarrhea due to chronic intestinal cryptosporidiosis in patients with AIDS.
- Trial name
- NCT00002264
- Testing
- Cryptosporidium Immune Whey Protein Concentrate (Bovine)
- Where
- United States
- Sponsor
- Stolle Milk Biologic International
Agammaglobulinemia, IgG Deficiency
Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)
The purpose of this study is to demonstrate the effect of IVIG-F10 on the prevention of serious bacterial infections in patients with primary immunodeficiency.
- Conditions
- Agammaglobulinemia, IgG Deficiency, Common Variable Immunodeficiency
- Trial name
- NCT00168012
- Testing
- Immunoglobulins Intravenous (Human)
- Volunteers
- 42 people
- Sponsor
- CSL Behring
HIV Infections
A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants
An open-label, two part study to assess the safety, tolerability, and PK of VH3810109 in healthy adult participants. Participants will receive a single SC or IV dose of VH3810109 co-administered with rHuPH20 and will be followed…
- Trial name
- SPAN (NCT05291520)
- Testing
- VH3810109, rHuPH20
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
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 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.
Melanoma, Non-small Cell Lung Cancer
A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies
This is a study to determine the maximum tolerated dose (MTD) for CDX-1140 (CD40 antibody), either alone or in combination with CDX-301 (FLT3L), pembrolizumab, or chemotherapy and to further evaluate its tolerability and efficacy…
- Conditions
- Melanoma, Non-small Cell Lung Cancer, Breast Cancer, Gastric Cancer
- Trial name
- NCT03329950
- Testing
- CDX-1140, CDX-301, pembrolizumab
- Where
- 11 sites in United States
- Volunteers
- 132 people
- Sponsor
- Celldex Therapeutics
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
IgA Nephropathy, Lupus Nephritis (LN)
A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G
A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 16 Years or Older with Immunoglobulin A Nephropathy…
- Conditions
- IgA Nephropathy, Lupus Nephritis (LN), C3 (Complement Component 3) Glomerulopathy
- Trial name
- NCT06419205
- Testing
- ADX-097
- Where
- 4 sites in United States, Brazil
- Volunteers
- 30 people
- Sponsor
- Akebia Therapeutics
Primary Immune Deficiency
Safety Study of Subcutaneous Ig NextGen 16% in Patients With Primary Immunodeficiency
The study aims to assess the safety and tolerability of subcutaneous Ig NextGen 16% in patients with Primary Immune Deficiency who require Immunoglobulin (Ig) G replacement therapy.
- Trial name
- NCT00680446
- Testing
- Immunoglobulin G (Ig NextGen 16%)
- Where
- 9 sites in Australia, New Zealand
- Volunteers
- 41 people
- Sponsor
- CSL Limited
Primary Immunodeficiency
A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency
The purpose of the study is to determine whether biweekly (every 2 weeks) administration of Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) produces a steady-state area under the…
- Trial name
- NCT04566692
- Testing
- IGSC 20%
- Where
- 12 sites in United States
- Volunteers
- 33 people
- Sponsor
- Grifols Therapeutics LLC
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
Primary Immunodeficiency Diseases (PID)
Immune Globulin Subcutaenous (Human), 20%
The purpose of the study is to develop a 20% subcutaneous immunoglobulin treatment option for patients with primary immunodeficiency (PID) diseases.
- Trial name
- NCT01412385
- Testing
- Immune Globulin Subcutaneous (Human), 20%, Immune Globulin Intravenous (Human), 10%, Human Normal Immunoglobulin (Subcutaneous - Intramuscular Immunoglobulin)
- Where
- 12 sites in Austria, Germany and 3 more
- Volunteers
- 55 people
- Sponsor
- Baxalta now part of Shire