Clinical trials: Immunoglobulin Deficiency
Primary Immune Deficiency
Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency
The purpose of this study is to evaluate the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects with Primary Humoral Immunodeficiency (PHID).
- Trial name
- NCT04565015
- Testing
- GC5107
- Where
- 8 sites in United States, Bosnia and Herzegovina and 1 more
- Volunteers
- 24 people
- Sponsor
- GC Biopharma Corp
Hypogammaglobulinemia
Subcutaneous Ig in Allogeneic Stem Cell Transplant Recipients
Tolerability of home subcutaneous immunoglobulin (ScIG) for replacement therapy for hypogammaglobulinemia in allogeneic HCT patients.
- Trial name
- ScIGalloHCT (NCT03401268)
- Testing
- subcutaneous immunoglobulin
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- University Health Network, Toronto
Cryptosporidiosis, HIV Infections
A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the Efficacy and Safety of Bovine Anti-Cryptosporidium Immunoglobulin (BACI) in the Treatment of Cryptosporidium Enteritis in AIDS Patients
PRIMARY: To assess the effect of bovine anti-Cryptosporidium immunoglobulin (BACI) on the volume of diarrhea due to Cryptosporidium parvum in AIDS patients who have protracted Cryptosporidium enteritis.
- Trial name
- NCT00002248
- Testing
- Cryptosporidium Immune Whey Protein Concentrate (Bovine)
- Where
- 6 sites in United States
- Volunteers
- 40 people
- Sponsor
- Univax 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
Pneumococcal Vaccines, HIV
Conjugate And Polysaccharide Vaccines Compared With Polysaccharide Vaccine In Hiv-Infected Adults
Randomised study comparing two pneumococcal vaccination strategies in HIV-infected adults with moderate immunossupression (CD4 between 200 and 500 cells/uL and viral load under 5logs), one with conjugated heptavalent…
- Conditions
- Pneumococcal Vaccines, HIV, HIV Infections
- Trial name
- NCT00999739
- Testing
- Prevenar and Pneumo23
- Where
- 2 sites in Spain
- Volunteers
- 220 people
- Sponsor
- Hospital Universitari Son Dureta
SCID
JSP191 Antibody Targeting Conditioning in SCID Patients
A Phase 1/2 study to evaluate the safety, tolerability, and efficacy of an antibody conditioning regimen, known as JSP191, in patients with Severe Combined Immune Deficiency undergoing blood stem cell transplantation
- Trial name
- NCT02963064
- Testing
- Humanized anti-CD117 Monoclonal Antibody (JSP191)
- Where
- 9 sites in United States
- Volunteers
- 23 people
- Sponsor
- Jasper Therapeutics, Inc.
HIV Infections
The Effectiveness of Human Antibodies in Influencing an AIDS-Like Disease in Monkeys
The purpose of this study is to see if an investigational vaccine can make antibodies (proteins found in blood) in humans that will influence the course of an AIDS-like disease in monkeys.
- Trial name
- NCT00031109
- Testing
- gp160 MN/LAI-2, Aluminum hydroxide
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
X-linked Hypophosphatemia (XLH)
Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Pediatric Chinese Patients With XLH
The purpose of this study is to assess the safety, pharmacokinetics and efficacy of KRN23 in pediatric Chinese patients with XLH
- Trial name
- NCT04842032
- Testing
- KRN23
- Where
- 5 sites in China
- Volunteers
- 28 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Human Immunodeficiency Virus
3BNC117 and 10-1074 in HIV Uninfected Adults
This is a phase 1 clinical trial to evaluate the safety and pharmacokinetics of the highly neutralizing anti-human immunodeficiency virus-1 monoclonal antibodies 3BNC117 and 10-1074, when given in combination, in human…
- Trial name
- NCT02824536
- Testing
- 3BNC117, 10-1074
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Rockefeller University
HIV Infections
Effects on the Immune System of Anti-HIV Drugs in Patients Recently Infected With HIV
The purpose of this study is to find out whether these powerful combinations of anti-HIV drugs are safe and effective for use in patients in the early stages of HIV infection and to find out how patients' immune systems react to…
- Trial name
- NCT00001119
- Testing
- Tetanus Toxoid Vaccine, Indinavir sulfate, Lamivudine/Zidovudine
- Where
- 12 sites in United States, Australia
- Volunteers
- 288 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Primary Immunodeficiency Disease, Secondary Immunodeficiency
Safety, Tolerability, Patient Satisfaction and Cost of 16.5% Subcutaneous Immunoglobulin (Cutaquig®) Treatment
Patients with primary or secondary immunodeficiency disease who have developed adverse reactions to products available on the market such as Cuvitru® (Shire), Hizentra® (CSL Behring) or 10% Gammunex® (Grifols), may benefit from…
- Trial name
- NCT03677557
- Testing
- 16,5% Cutaquig
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- Ottawa Hospital Research Institute
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
HIV Infections
Safety and Therapeutic Efficacy of the VRC01 Antibody in Patients Who Initiated Antiretroviral Therapy During Early Acute HIV Infection
The study will evaluate the safety and therapeutic efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01), when administered during analytic treatment interruption (ATI), in adults who began antiretroviral…
- Trial name
- NCT02664415
- Testing
- VRC01
- Where
- Thailand
- Volunteers
- 23 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Primary Immune Deficiency Disorder
Study of Immune Globulin Intravenous (Human) GC5101F in Subjects With Primary Humoral Immunodeficiency
To assess the safety, efficacy, and pharmacokinetics of IGIV-SN in pediatric subjects with primary immunodeficiency humoral diseases (PHID)
- Trial name
- NCT03492710
- Testing
- Immunoglobulin
- Sponsor
- Green Cross Corporation
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
Hereditary Angioedema Types I and II
Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert
This is a prospective, international, multi-center, non-randomized, single arm, open-label, postmarketing study to investigate the formation of inhibitory anti-C1-INH antibodies in HAE subjects treated intravenously with…
- Trial name
- NCT01467947
- Testing
- Berinert, lyophilizate for IV application containing 500 IU C1-INH to be reconstituted with 10 mL water for injection
- Where
- 4 sites in Bulgaria, Hungary and 2 more
- Volunteers
- 46 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
HIV Infection, Syphilis Infection
Multiplo Tp/HIV Self-Test
To help reach the undiagnosed living with HIV and/or syphilis in Canada, self-tests for HIV and Syphilis may have substantial utility for increased identification of infected individuals through their relative ease of use and…
- Trial name
- NCT06716450
- Testing
- Multiplo TP/HIV Antibody Test
- Where
- 3 sites in Canada
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- Unity Health Toronto
HIV Infections
A Study of Anti-HIV Monoclonal Antibody KD-247
The purpose of this study is to evaluate the safety and tolerability of 3 infusions of KD-247 over 2 weeks in HIV-1 seropositive individuals; to determine the pharmacokinetic parameters of KD-247 when administered as above; and…
- Trial name
- NCT00917813
- Testing
- KD-247, Physiological saline
- Where
- 15 sites in United States
- Volunteers
- 27 people
- Sponsor
- The Chemo-Sero-Therapeutic Research Institute
Human Immunodeficiency Virus (HIV)
3BNC117 and 10-1074 in HIV-infected Individuals
This is a phase 1b clinical trial to evaluate the safety, pharmacokinetics and the antiretroviral effects of the combination of two anti-human immunodeficiency virus (HIV) broadly neutralizing antibodies, 3BNC117 and 10-1074…
- Trial name
- NCT02825797
- Testing
- 3BNC117, 10-1074, Analytical treatment interruption
- Where
- 2 sites in United States, Germany
- Volunteers
- 34 people
- Sponsor
- Rockefeller University