Clinical trials: Intravenous Immunoglobulin
Primary Immunodeficiency Disease
Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID
This Phase III clinical study is to test efficacy, safety and pharmacokinetics of BT595 in treating patients with Primary Immunodeficiency (PID)
- Trial name
- NCT02810444
- Testing
- IgG Next Generation (BT595)
- Where
- 19 sites in United States, Germany and 3 more
- Volunteers
- 81 people
- Sponsor
- Biotest
End Stage Renal Disease
Use of Immune Globulin Plus Rituximab for Desensitization in Highly HLA Sensitized Patients Awaiting Deceased Donor Kidney Transplantation
This single center, Phase I/II, exploratory study has been modified to a safety/efficacy study providing all patients with IVIG and Rituximab.
- Trial name
- NCT01178216
- Testing
- Rituxan
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Stanley Jordan, MD
Osteoarthritis, Knee
A Phase 1/2A, Single Dose Study Of PF-04383119 In Japanese Patients With Moderate To Severe Pain From Osteoarthritis Of The Knee
To evaluate the safety and tolerability of single IV doses of PF-04383119 in Japanese patients with moderate to severe pain from OA of the knee (Part I).
- Trial name
- NCT00669409
- Testing
- PF-04383119 (tanezumab)
- Where
- 12 sites in Japan
- Volunteers
- 83 people
- Sponsor
- Pfizer
Idiopathic Pulmonary Fibrosis
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibody (mAb) in Patients With IPF (SAD).
Assess the safety of CHF10067 (study drug) and any side effects that might be associated with it. The study also evaluated how much of the study drug gets into the bloodstream and how long the body takes to remove it.
- Trial name
- NCT05513950
- Testing
- CHF10067 starting dose -- 1000mg (Cohort A), CHF10067 intermediate dose -- 2000mg (Cohort B), CHF10067 high dose -- 3000mg (Cohort C)
- Where
- 9 sites in North Macedonia, Ukraine and 1 more
- Volunteers
- 52 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Smallpox Vaccine Adverse Reaction
VA-008 ACAM2000® Vaccination of Plasma Donors for the Production of VIGIV
Objectives: To vaccinate plasma donors with the ACAM2000 smallpox vaccine thereby inducing an immune response resulting in high anti-vaccinia antibody titers.
- Trial name
- NCT02443623
- Testing
- Vaccination with ACAM2000
- Where
- Canada
- Volunteers
- 3,032 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Asthma
A Study to Evaluate the Effect of a Single-Dose Intravenous Administration of MEDI-528
To evaluate the effect of MEDI-528 in adults with atopic asthma.
- Trial name
- NCT00483041
- Testing
- MEDI528 9 mg/kg
- Where
- 4 sites in United States
- Volunteers
- 11 people
- Sponsor
- MedImmune LLC
Diffuse Cutaneous Systemic Sclerosis
Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)
This is a prospective, multicenter, randomized, open-label, crossover study to investigate the safety, tolerability, and pharmacokinetics of IgPro20 in participants with diffuse cutaneous systemic sclerosis (dcSSc).
- Trial name
- NCT04137224
- Testing
- IgPro20, IgPro10
- Where
- 9 sites in Australia, Germany and 3 more
- Volunteers
- 27 people
- Sponsor
- CSL Behring
Postural Tachycardia Syndrome
IVIG (Gamunex-C) Treatment Study for POTS Subjects
The purpose of this trial is to evaluate the symptomatic benefits of immunomodulatory treatment with IVIG for POTS (postural tachycardia syndrome) patients with evidence of autoimmunity.
- Trial name
- iSTAND (NCT03919773)
- Testing
- IVIG, Albumin
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Texas Southwestern Medical Center
HIV
A Phase 1 Trial to Evaluate CAP256V2LS in Healthy Adults
Background: HIV is a serious disease with no cure or vaccine to prevent it. Using antibodies could be a way to prevent HIV infection. Antibodies are made by the human body to fight germs.
- Trial name
- VRC 611 (NCT04408963)
- Testing
- VRC-HIVMAB0102-00-AB
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
T-cell Type Acute Leukemia-Precursor, T-lymphoblastic Lymphoma/Leukaemia
Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia
Primary Objective: To evaluate the efficacy of isatuximab. Secondary Objectives: To evaluate the safety profile of isatuximab. To evaluate the duration of response (DOR).
- Trial name
- ISLAY (NCT02999633)
- Testing
- Isatuximab SAR650984, dexamethasone, acetaminophen
- Where
- 17 sites in United States, Finland and 5 more
- Volunteers
- 14 people
- Sponsor
- Sanofi
Rheumatoid Arthritis
Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis
This study was intended to evaluate the safety and efficacy of intravenous (IV) ACZ885 and oral methotrexate (MTX) therapy in patients with early rheumatoid arthritis (RA)
- Trial name
- NCT00487825
- Testing
- Canakinumab (investigational), Methotrexate (MTX)
- Where
- 22 sites in United States, Belgium and 4 more
- Volunteers
- 78 people
- Sponsor
- Novartis
Primary Immunodeficiency (PID)
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (EU Extension Study)
This study is a continuation of the study ZLB06_001CR with the objective of assessing efficacy, tolerability, safety of IgPro, as well as long-term health-related quality of life in patients with PID.
- Trial name
- NCT00751621
- Testing
- IgPro20
- Where
- 13 sites in France, Germany and 6 more
- Volunteers
- 40 people
- Sponsor
- CSL Behring
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment
This study was a multi-center, randomized, open-label, active comparator-controlled, parallel group study. The purpose of this Phase 3 study in PNH patients presenting with residual anemia despite treatment with anti-C5 antibody…
- Trial name
- APPLY-PNH (NCT04558918)
- Testing
- LNP023, Eculizumab, Ravulizumab
- Where
- 39 sites in United States, Brazil and 10 more
- Volunteers
- 97 people
- Sponsor
- Novartis Pharmaceuticals
Alzheimer´s Disease
Phase 3 IGIV, 10% in Alzheimer´s Disease
The purpose of this study is to provide evidence of efficacy and safety to support the development of IGIV, 10% as a treatment option for patients with mild to moderate Alzheimer´s Disease.
- Trial name
- NCT01524887
- Testing
- Immune Globulin Intravenous (Human), 10% Solution, Human albumin 0.25%
- Where
- 69 sites in United States, Australia and 6 more
- Volunteers
- 508 people
- Sponsor
- Baxalta now part of Shire
End Stage Renal Disease (ESRD)
A Safety Study of Tocilizumab to Improve Transplant Rates in Highly Sensitized Patients Awaiting Kidney Transplantation
In this Phase I/II trial, 10 highly sensitized patients will be entered after informed consent and will receive Intravenous Immunoglobulin (IVIG) at 2 gm/kg + Tocilizumab 8 mg/kg x 5 doses on days 15, 45, 75, 105, 119, 135, and…
- Trial name
- NCT01594424
- Testing
- Tocilizumab, Intravenous Immunoglobulin
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Cedars-Sinai Medical Center
Idiopathic Pulmonary Fibrosis, Acute Fatal Form
Autoantibody Reduction for Acute Exacerbations of Idiopathic Pulmonary Fibrosis
Acute exacerbations (AE) are a dreaded manifestation of idiopathic pulmonary fibrosis (IPF) that presents with rapidly worsening respiratory function over days to weeks.
- Trial name
- STRIVE-IPF (NCT03286556)
- Testing
- Autoantibody Reductive Therapy, Treatment as Usual (TAU)
- Where
- 7 sites in United States
- Volunteers
- 82 people
- Sponsor
- University of Alabama at Birmingham
Arthritis, Juvenile
A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy
The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) of golimumab administered intravenously (IV) to pediatric participants with…
- Trial name
- GO-VIVA (NCT02277444)
- Testing
- Golimumab, Methotrexate
- Where
- 38 sites in United States, Argentina and 7 more
- Volunteers
- 130 people
- Sponsor
- Janssen Research & Development, LLC
Autoimmune Epilepsy
IVIG in Patients With VGKC Ab Associated Autoimmune Epilepsy
The purpose of this study is to determine whether intravenous immunoglobulin (IVIG) treatment reduces significantly the number of epileptic seizures in cases of autoimmune epileptic seizures.
- Trial name
- NCT02697292
- Testing
- Intravenous Immunoglobulin, Normal Saline
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Mayo Clinic
Multiple Myeloma, Plasma Cell Neoplasm
Human Immune Globulin in Treating Patients With Primary Amyloidosis That is Causing Heart Dysfunction
RATIONALE: Antibodies, such as human immune globulin, can block the growth of abnormal cells in different ways. Some block the ability of abnormal cells to grow and spread.
- Trial name
- NCT00547365
- Testing
- Human immune globulin intravenous (IGIV)
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- University of Tennessee
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