Clinical trials: Antibody Deficiency
Primary Immunodeficiency Disease
Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients (KIDCARES10)
The purpose of this study is to assess efficacy, safety and pharmacokinetics of Kedrion Immunoglobulin 10% (KIg10) in pediatric patients with Primary Immunodeficiency Disease (PID).
- Trial name
- KIDCARES10 (NCT04944979)
- Testing
- Kedrion IVIG 10%
- Where
- 21 sites in United States, Hungary and 4 more
- Volunteers
- 30 people
- Sponsor
- Kedrion S.p.A.
HIV Infections
Prevalence of Substance Abuse Among Anti-retroviral Treatment Naive Patients Positive for HIV Antibodies
Individuals utilise substances to elevate their mood. Alcohol, cannabis, nicotine, cocaine, and methamphetamine are examples of substances.
- Trial name
- NCT04847388
- Testing
- Substance like alcohol, marijuana, etc.
- Where
- India
- Volunteers
- 210 people
- Sponsor
- Singh, Ranjan Kumar, M.D.
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
HIV Infections, Hepatitis B
Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs
The purpose of this study is to determine if 2 doses of Pneumococcal Conjugate Vaccine (PCV) followed by 1 dose of Pneumococcal Polysaccharide Vaccine (PPV) in HIV-infected children on anti-HIV therapy is helpful and safe in…
- Conditions
- HIV Infections, Hepatitis B, Measles, Pneumococcal Infections
- Trial name
- NCT00013871
- Testing
- Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed, Measles-Mumps-Rubella Vaccine (Live), Pneumococcal Vaccine, Polyvalent (23-valent)
- Where
- 40 sites in United States, Puerto Rico
- Volunteers
- 300 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Immunologic Deficiency Syndromes
A Clinical Study of Intravenous Immunoglobulin
The purpose of this study is to measure the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human) [IGIV], 5% Solution Omr-IgG-am™ in patients with primary immunodeficiency diseases.
- Trial name
- IGIV (NCT00468273)
- Testing
- Immune Globulin Intravenous (Human) Omr-IgG-am IGIV
- Where
- 10 sites in United States, Canada
- Volunteers
- 57 people
- Sponsor
- FFF Enterprises
Primary Antibody Deficiency
A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam®
The primary objective was to determine the efficacy of Human Normal Immunoglobulin (Subgam®) given subcutaneously by weekly infusion to patients with primary antibody deficiency.
- Trial name
- NCT02247141
- Testing
- Subgam® (Human Normal Immunoglobulin Solution)
- Where
- 14 sites in United Kingdom
- Sponsor
- Bio Products Laboratory
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.
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.
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.
Immunologic Deficiency Syndromes
Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency
The purpose of this study is to evaluate the safety, efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) GC5107 in subjects with Primary Humoral Immunodeficiency (PHID).
- Trial name
- NCT02783482
- Testing
- GC5107
- Where
- 20 sites in United States, Canada
- Volunteers
- 49 people
- Sponsor
- Green Cross Corporation
HIV Infections
Evaluating the Safety and Antiviral Activity of Monoclonal Antibody VRC01 in Infants With HIV Receiving Combination Antiretroviral Therapy
The purpose of this study was to evaluate the safety and antiviral activity to promote clearance of HIV-1 infected cells of VRC01 in infants with HIV beginning combination antiretroviral therapy (cART).
- Trial name
- NCT03208231
- Testing
- VRC01, Combination Antiretroviral Therapy (cART)
- Where
- 7 sites in Botswana, Brazil and 2 more
- Volunteers
- 61 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cytomegalovirus Retinitis, HIV Infections
Comparison of Two Methods in the Treatment of Cytomegalovirus of the Eyes in Patients With AIDS
To evaluate the effect of MSL 109, human monoclonal anti-cytomegalovirus (CMV) antibody, on time to progression of CMV retinitis. To determine the safety and pharmacokinetic profile of MS 109.
- Trial name
- NCT00001061
- Testing
- Sevirumab, Foscarnet sodium, Ganciclovir
- Where
- 20 sites in United States
- Volunteers
- 167 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Idiopathic Growth Hormone Deficiency
A Follow-up Study to Examine the Presence of Anti-human Growth Hormone Antibodies Following a Study (FE 999905 CS07) of Zomacton in Children With Growth Hormone Deficiency
This is a follow-up study of patients, treated with one daily dose of Zomacton or one daily dose of Genotropin in the previously completed FE 999905 CS07 trial, who had presence of anti-hGH antibodies at any post-dosing visit…
- Trial name
- NCT02173821
- Testing
- Blood sampling
- Where
- 7 sites in Hungary, India and 5 more
- Volunteers
- 23 people
- Sponsor
- Ferring Pharmaceuticals
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
Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases
The main objective of the study is to determine the pharmacokinetics profile of Subgam-VF. The secondary objectives are to assess the safety of Subgam-VF and refine the dose adjustment coefficient for Subgam-VF needed for…
- Conditions
- Primary Immune Deficiency Disorders, Common Variable Immunodeficiency, X-linked Agammaglobulinaemia, Hyperimmunoglobulin M Syndrome
- Trial name
- SCIG03 (NCT01884311)
- Testing
- Subgam
- Where
- 16 sites in United States
- Volunteers
- 38 people
- Sponsor
- Bio Products Laboratory
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
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
Hereditary Angioedema
Safety and Pharmacokinetics of GNR-038 in Healthy Volunteers
It is an open-label dose-escalating study in sequential cohorts to assess safety and pharmacokinetics of GNR-038.
- Trial name
- NCT04557319
- Testing
- GNR-038, 25 МЕ/kg, GNR-038, 50 МЕ/kg, GNR-038, 100 МЕ/kg
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- AO GENERIUM
HIV Infection
Analytical Treatment Interruption (ATI) to Assess the Immune System's Ability to Control HIV in Participants Who Became HIV-infected During the HVTN 704/HPTN 085 AMP Study
The purpose of this study is to learn whether having the AMP Study antibody (called VRC01) in a person's body might help their immune system control HIV better, even without HIV medication called antiretroviral therapy or ART, if…
- Trial name
- NCT04801758
- Testing
- Analytical Treatment Interruption
- Where
- 6 sites in Brazil, Peru
- Volunteers
- 18 people
- Sponsor
- HIV Vaccine Trials Network
HIV Infections
The Effects of Anti-HIV Therapy on the Immune Systems of Children and Young Adults Infected With HIV
The purpose of this study is to determine the number of newly formed CD4 cells in children who have taken anti-HIV drugs. The study will also evaluate the effectiveness of the new CD4 cells in producing an immune response to…
- Trial name
- NCT00004735
- Testing
- Tetanus toxoid, Hepatitis A Vaccine (Inactivated)
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 81 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)