Clinical trials: Primary Immune Deficiency Disorders
Hereditary Angioedema
First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers
This is a 3-part Phase 1 dose-ranging study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single (Part 1) and multiple (Part 2) ascending doses of BCX7353 in healthy subjects, and single and…
- Trial name
- NCT02448264
- Testing
- BCX7353
- Where
- United Kingdom
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- BioCryst Pharmaceuticals
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
Hereditary Angioedema
A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)
The purpose of this study is to evaluate the long-term safety and efficacy of donidalorsen in people with HAE and the effects of donidalorsen on the number of HAE attacks and their impact on quality of life (QoL).
- Trial name
- NCT05392114
- Testing
- Donidalorsen
- Where
- 50 sites in United States, Belgium and 12 more
- Volunteers
- 154 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Primary Immune Deficiency (PID)
Ig NextGen 10% in Patients With Primary Immune Deficiency (PID)
This study aims to assess the safety, tolerability and pharmacokinetics of Ig NextGen 10% in patients with primary immune deficiency currently being treated with Intragam P.
- Trial name
- NCT00405184
- Testing
- IntragamP, Ig NextGen 10%
- Where
- 4 sites in Australia
- Volunteers
- 19 people
- Sponsor
- CSL Limited
Advanced Solid Tumors
Study to Test How Well Patients With Advanced Solid Tumors Respond to Treatment With the Elimusertib in Combination With Pembrolizumab, to Find the Optimal Dose for Patients, How the Drug is Tolerated and the Way the Body Absorbs, Distributes and Discharges the Drug
The purpose of the study is to test how well patients with advanced solid tumors respond to treatment with elimusertib (BAY1895344) in combination with pembrolizumab.
- Trial name
- NCT04095273
- Testing
- Elimusertib (BAY1895344), Pembrolizumab (Keytruda®)
- Where
- 16 sites in United States, Germany and 3 more
- Volunteers
- 56 people
- Sponsor
- Bayer
Hereditary Angioedema, Hereditary Angioedema Type I
Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema
This study evaluates the safety and efficacy of long-term on-demand treatment with orally administered deucrictibant for acute hereditary angioedema (HAE) attacks, including laryngeal attacks.
- Conditions
- Hereditary Angioedema, Hereditary Angioedema Type I, Hereditary Angioedema Type II, Hereditary Angioedema Types I and II
- Trial name
- RAPIDe-2 (NCT05396105)
- Testing
- deucrictibant
- Where
- 60 sites in United States, Argentina and 22 more
- Volunteers
- 150 people
- Sponsor
- Pharvaris Netherlands B.V.
Mental Health Issue, Hiv
Walk-in Therapy in Low Barrier Primary Care
The goals of the current research are to adapt an effective walk-in psychotherapy clinic intervention for the context of low-barrier primary care; and conduct a pilot implementation study in a low-barrier primary care clinic…
- Conditions
- Mental Health Issue, Hiv, Substance Use
- Trial name
- NCT06552325
- Testing
- Single Session Narrative Therapy
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- University of Washington
Primary Immune Deficiency
Screening Protocol for Genetic Diseases of Lymphocyte Homeostasis and Programmed Cell Death
This study will determine the biochemical and genetic causes of inherited immune diseases affecting lymphocyte homeostasis. Lymphocytes are a type of white blood cell that fights infections.
- Trial name
- NCT00246857
- Where
- 8 sites in United States, Turkey (Türkiye)
- Volunteers
- 5,000 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hiv
Innovative Strategies to Increase ART Initiation and Viral Suppression Among HIV-positive Men in Malawi
Men in Sub-Saharan Africa are less likely to test for HIV, initiate ART, and more likely to initiate ART at later stages of disease.
- Trial name
- NCT04878601
- Testing
- Home-Based ART, Facility-Based ART
- Where
- Malawi
- Volunteers
- 470 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
Hereditary Angioedema
A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3)
This study is being conducted to evaluate the efficacy and safety of icatibant compared to placebo in patients experiencing acute attacks of hereditary angioedema (HAE).
- Trial name
- NCT00912093
- Testing
- Icatibant
- Where
- 64 sites in United States, Australia and 7 more
- Volunteers
- 98 people
- Sponsor
- Shire
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
Hereditary Angioedema
An Extension Study of Donidalorsen (IONIS-PKK-LRx) in Participants With Hereditary Angioedema
The purpose of this study was to evaluate the safety and efficacy of extended dosing of donidalorsen administered subcutaneously (SC), with alternative dosing and/or dose frequency with donidalorsen in participants with…
- Trial name
- NCT04307381
- Testing
- Donidalorsen
- Where
- 7 sites in United States, Netherlands
- Volunteers
- 20 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Primary Immunodeficiency Diseases (PID)
Real-world CANadian CUvitru Non-Interventional Study in Subjects Transitioning From Subcutaneous Immunoglobulin (CANCUN)
This study will provide insights on the infusion parameters, dosing, and experience of participants transitioning to CUVITRU in a real-world setting.
- Trial name
- NCT03716700
- Testing
- CUVITRU
- Where
- 3 sites in Canada
- Volunteers
- 126 people
- Sponsor
- Baxalta now part of Shire
HIV Infections
A Study of Patients Who Recently Have Been Infected With HIV
The purpose of this study is to find out if anti-HIV drugs, taken by patients who are newly infected with HIV, can make the level of HIV in the body too low to detect.
- Trial name
- NCT00006415
- Where
- United States
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Trauma, Inflammation
Effect of C1-esterase Inhibitor on Systemic Inflammation in Trauma Patients With a Femur or Pelvic Fracture
Trauma and major operation are associated with an excessive inflammation reaction due to tissue injury. This overwhelming immune response is considered to be a major risk factor in the pathogenesis of late inflammatory…
- Conditions
- Trauma, Inflammation, Sepsis, Multiple Organ Dysfunction Syndrome
- Trial name
- CAESAR (NCT01275976)
- Testing
- C1-esterase inhibitor, Saline 0.9%
- Where
- Netherlands
- Volunteers
- 11 people
- Sponsor
- UMC Utrecht
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
AIDS-Related-Primary Central Nervous System Lymphoma
Chemotherapy and HAART to Treat AIDS-related Primary Brain Lymphoma
This study will investigate the use of chemotherapy plus highly active antiretroviral therapy (HAART) in patients with Acquired Immunodeficiency Syndrome (AIDS)-related primary brain lymphoma.
- Trial name
- NCT00267865
- Testing
- Methotrexate, Rituximab, Leucovorin
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- National Cancer Institute (NCI)
Ataxia Telangiectasia, Leukemia
Treatment of Leukemia and Lymphoma in Children With Ataxia Telangiectasia
Ataxia telangiectasia (A-T) is a multisystem disease with diverse manifestations, including progressive neurodegeneration, immunodeficiency, respiratory disease, and genomic instability.
- Conditions
- Ataxia Telangiectasia, Leukemia, Lymphoma
- Trial name
- NCT04037189
- Where
- Israel
- Volunteers
- 250 people
- Sponsor
- Rabin Medical Center
Chronic Myeloproliferative Disorders, Diamond-blackfan Anemia
Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer
RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's…
- Conditions
- Chronic Myeloproliferative Disorders, Diamond-blackfan Anemia, Fanconi Anemia, Graft Versus Host Disease
- Trial name
- NCT00290628
- Testing
- anti-thymocyte globulin, busulfan, cyclophosphamide
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Campylobacter Infections
Recurrent Campylobacter Bacteraemia in Immunocompromised Patients
Some rare cases of recurrent Campylobacter bacteraemia (RCB) exist with relapses months to years after an effective treatment and a negativation of all bacterial samples.
- Trial name
- CABARET (NCT06432777)
- Testing
- Characteristics of patients and Campylobacter bacteraemia episodes
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Hospices Civils de Lyon