Clinical trials: Primary Immune Deficiency Disorders
Primary Immune Deficiency Disorder
Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)
This is a Phase III, multicenter, open-label study of RI-002 administered as an intravenous infusion of RI-002 (IGIV) every 21 or 28 days in approximately 60 subjects with Primary Immunodeficiency Diseases (PIDD).
- Trial name
- NCT01814800
- Testing
- RI-002
- Where
- 9 sites in United States
- Volunteers
- 59 people
- Sponsor
- ADMA Biologics, Inc.
Primary Immune Deficiency
Antibody Production in Immune Disorders
This study will evaluate immune function in people with a known or suspected immune disorder. It will determine participants immune response to vaccines by measuring blood antibody levels after vaccination.
- Trial name
- NCT00023504
- Testing
- Pneumovax, Rabavert, Prevnar
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hereditary Angioedema
Study to Determine How BCX4161 is Metabolized and Eliminated by the Body
The purpose of the study is to assess the extent that radioactive dose of BCX4161 taken by mouth ends up in the urine, feces and expired air.
- Trial name
- NCT02218294
- Testing
- BCX4161
- Where
- United Kingdom
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- BioCryst Pharmaceuticals
Hereditary Angioedema
A Study of the Relative Bioavailability of a New Formulation of BCX4161 and the Effect of Food on BCX4161
The purpose of the study is to compare how the body takes up and then eliminates the study drug BCX4161 when it is taken orally as a hard gelatin capsule and as a soft gelatin capsule.
- Trial name
- NCT02125162
- Testing
- BCX4161
- Where
- United Kingdom
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- BioCryst Pharmaceuticals
Hereditary Angioedema (HAE)
A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema
This study is a survey in Japan of Icatibant subcutaneous injection 30 mg syringe used to treat children or teenagers with acute attacks of hereditary angioedema (HAE).
- Trial name
- NCT05509569
- Testing
- Icatibant
- Where
- Japan
- Volunteers
- 32 people
- Sponsor
- Takeda
Ataxia-Telangiectasia (A-T), Ataxia-Telangiectasia
Sirolimus Treatment in Pediatric Patients With Ataxia-Telangiectasia
Ataxia-telangiectasia (A-T) is a progressive disease which is, to date, incurable, affecting motor skills, and a high cancer and recurrent infections risk.
- Trial name
- NCT07820579
- Testing
- Rapamune (sirolimus/rapamycin)
- Where
- Mexico
- Volunteers
- 6 people
- Sponsor
- Sara Elva Espinosa Padilla, MD
Hiv, Chlamydia
Online HIV Prevention for Young Male Couples
Young gay, bisexual, and other men who have sex with men (YMSM) are the only risk group in which rates of new HIV infections are on the rise.
- Conditions
- Hiv, Chlamydia, Gonorrhea
- Trial name
- 2GETHER (NCT03284541)
- Testing
- 2GETHER, Existing Public Health Practice
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Hereditary Angioedema
EAP for Deucrictibant Immediate-release
This is an expanded access program (EAP) designed to allow access to deucrictibant immediate-release (IR) capsule for eligible participants with hereditary angioedema (HAE) in the United States (US) and US territories who lack…
- Trial name
- NCT07759141
- Testing
- Deucrictibant IR
- Sponsor
- Pharvaris Netherlands B.V.
Growth Failure, X-linked Severe Combined Immunodeficiency (XSCID)
Treatment for Growth Failure in Patients With X-Linked Severe Combined Immunodeficiency: Phase 2 Study of Insulin-Like Growth Factor-1
This study will evaluate the safety and effectiveness of insulin-like growth factor-1 (IGF-1) to treat patients with X-linked severe combined immunodeficiency (XSCID).
- Conditions
- Growth Failure, X-linked Severe Combined Immunodeficiency (XSCID), Growth Hormone Resistence
- Trial name
- NCT00490100
- Testing
- Increlex
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Common Variable Immunodeficiency
Usage of Spirometry in Managing IgG Therapy in CVID With Airway Disease
Although there is evidence in the literature that gammaglobulin replacement therapy can lead to a reduction in the prevalence of pulmonary infection and improved lung function, there is no published study to guide immunologists…
- Trial name
- NCT05193552
- Testing
- Hizentra
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Severe Combined Immunodeficiency
Gene Transfer for Severe Combined Immunodeficiency, X-linked (SCID-X1) Using a Self-inactivating (SIN) Gammaretroviral Vector
Researchers are working on ways to treat SCID patients who don't have a matched brother or sister. One of the goals is to avoid the problems that happen with stem cell transplant from parents and unrelated people, such as repeat…
- Trial name
- NCT01129544
- Testing
- Gene transfer
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- David Williams
Primary Immunodeficiency
Minipooled-IVIG in Primary Immunodeficiency Disease
1. study the pharmacokinetics of mini-pooled intravenous immunoglobulin( MP-IVIG) 2. Study the safety and efficacy of a newly developed preparation of MP-IVIG in children with primary immunodeficiency (PID) : Adverse reaction of…
- Trial name
- NCT03896932
- Testing
- minipooled- Intravenous immunoglobulin(MP-IVIG)
- Where
- Egypt
- Volunteers
- 15 people
- Sponsor
- Assiut University
Primary or Secondary Immune Deficiency Including Immunosuppressive Therapy, Chemotherapy, HIV Infection
Performance of Clinical Metagenomics in Stool and Urine Samples for Unexplained Diseases Diagnostic and Emerging Diseases Surveillance in Immunocompromised Patients
The study is based on the hypothesis that the concomitant use of mNGS in non-invasive samples (stool, urine) could improve the rate of detected pathogens in immunodeficient patients compared with mNGS performed in an invasive…
- Trial name
- SENTINEL (NCT07603453)
- Testing
- Metagenomics
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Primary Immunodeficiency
IgG Level in Primary Immunodeficiency Switching From Standard SCIG to Every Other Week HyQvia
Most immunodeficiencies are related to severe immunoglobulin deficiencies which require lifelong replacement therapy with immunoglobulin G (IgG) to reduce the incidence and severity of infections.
- Trial name
- NCT02881437
- Testing
- IgHy10
- Where
- 7 sites in France
- Volunteers
- 22 people
- Sponsor
- University Hospital, Lille
Ataxia Telangiectasia
International Ataxia Rating Scale in Younger Patients
The project will collect information on the mapping of clinical ratings on a number of scales that are used in the assessment of patients with ataxias.
- Trial name
- NCT01942850
- Where
- 5 sites in United States, India and 2 more
- Volunteers
- 63 people
- Sponsor
- Quince Therapeutics S.p.A.
HIV Infections, Hypertension
ENHANCE-EvideNce Led Co-created HeAlth Systems interventioNs for MLTCs CarE
The goal of this study is to determine the effect of the ENHANCE intervention in improving clinical outcomes and evaluating the effects of the intervention on implementation processes and outcomes.
- Conditions
- HIV Infections, Hypertension, Diabetes Mellitus, Asthma
- Trial name
- ENHANCE (NCT06248190)
- Testing
- ENHANCE intervention (health systems)
- Where
- 32 sites in South Africa
- Volunteers
- 1,837 people
- Sponsor
- University of KwaZulu
HIV, HIV-Infections
The Visceral Adiposity Measurement and Observation Study
The Visceral Adiposity Measurement and Observation Study
- Conditions
- HIV, HIV-Infections, HIV-1-infection, HIV I Infection
- Trial name
- VAMOS (NCT05383456)
- Testing
- Diagnostic Test, HIV Anti-retroviral Background Therapy
- Where
- 8 sites in United States
- Volunteers
- 196 people
- Sponsor
- Theratechnologies
Leukemia, High Risk Acute Lymphoblastic Leukemia
Phase 1/2: CD45RA Depleted Stem Cell Addback to Prevent Viral or Fungal Infections Post TCRab/CD19 Depleted HSCT
The major morbidities of allogeneic hematopoietic stem cell transplant (HSCT) using donors that are not human leukocyte antigen (HLA) matched siblings are graft vs host disease (GVHD) and life- threatening infections.
- Conditions
- Leukemia, High Risk Acute Lymphoblastic Leukemia, High Risk Acute Myeloid Leukemia, Relapse Leukemia
- Trial name
- NCT06839456
- Testing
- Phase 1 Dose Level 1, Phase 1 Dose Level 2, Phase 1 Dose Level 3
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Children's Hospital of Philadelphia
HIV Infections, Men
Improving HIV Testing, Linkage, and Retention in Care for Men Through U=U Messaging
This study will evaluate the impact of U=U messaging and counseling on gaps in the HIV care cascade for men, including testing uptake and ART initiation (Aim 1), achieving viral suppression and retention in care (Aim 2) in two…
- Conditions
- HIV Infections, Men, Treatment Adherence
- Trial name
- NCT05602376
- Testing
- U=U testing messaging scripts, U=U adherence messaging scripts
- Where
- 2 sites in South Africa
- Volunteers
- 3,642 people, healthy volunteers welcome
- Sponsor
- Desmond Tutu HIV Foundation
Meningococcal Vaccine
Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When Administered to Immunocompromised Participants ≥10 Years of Age
The aim of this study is to evaluate the safety, tolerability, and immunogenicity of 2 doses of Trumenba® (on a 0- and 6-month schedule) in immunocompromised participants by functionally assessing antibody production in asplenic…
- Trial name
- NCT04893811
- Testing
- Trumenba
- Where
- 14 sites in Czechia, Poland and 1 more
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Pfizer