Common Variable Immunodeficiency Clinical Trial
Official title:
A Multicenter Study on the Efficacy and Safety of Vivaglobin® in Previously Untreated Patients (PUPs) With Primary Immunodeficiency (PID)
The objective of this study is to assess the efficacy and safety of Vivaglobin in previously untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation period. The purpose is to investigate whether PUPs will respond to subcutaneous immunoglobulin (SCIG) treatment with adequate trough levels without first receiving immunoglobulins by the intravenous route by demonstrating that 100 mg immunoglobulin G/kg body weight (IgG/kg bw) administered on 5 consecutive days (i.e. resulting in a total dose of 500 mg IgG/kg bw) results in an IgG increase to ≥ 5 g/L on Day 12 after initiation of SCIG therapy.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03663933 -
Allogeneic Hematopoietic Cell Transplantation for Disorders of T-cell Proliferation and/or Dysregulation
|
Phase 2 | |
| Recruiting |
NCT01652092 -
Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies
|
N/A | |
| Recruiting |
NCT05321407 -
COVID-19 Vaccine Responses in PIDD Subjects
|
||
| Recruiting |
NCT04339777 -
Allogeneic Hematopoietic Stem Cell Transplant for Patients With Inborn Errors of Immunity
|
Phase 2 | |
| Completed |
NCT00542997 -
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy
|
Phase 3 | |
| Completed |
NCT00168012 -
Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)
|
Phase 3 | |
| Completed |
NCT00168025 -
Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
|
Phase 3 | |
| Completed |
NCT00004695 -
Randomized Study of Polyethylene-Glycol-Conjugated Interleukin 2 in Patients With Common Variable Immunodeficiency
|
N/A | |
| Completed |
NCT01196702 -
Lymphocyte Immunophenotyping in Common Variable Immunodeficiency
|
||
| Recruiting |
NCT06355323 -
Bronchiectasis Prevalence in Patients With Primary Humoral Immunodefiency in Champagne-Ardenne Region, France
|
N/A | |
| Completed |
NCT00322556 -
Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
|
Phase 3 | |
| Recruiting |
NCT02579967 -
Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies
|
Phase 2 | |
| Recruiting |
NCT06145100 -
Prediction of Portal Hypertension in Patients With CVID (CVID-pHT)
|
||
| Completed |
NCT01289847 -
A Study to Find Out How Safe and Effective Gammaplex® is in Young People With Primary Immunodeficiency
|
Phase 4 | |
| Terminated |
NCT00006054 -
Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies
|
N/A | |
| Completed |
NCT03211689 -
The Impact of Exercise on Stress, Fatigue, and Quality of Life in Individuals With Primary Immunodeficiency Disease
|
N/A | |
| Terminated |
NCT01489618 -
"Prime Boost" Vaccination Strategy Combining Conjugated Anti- Pneumococcal Vaccine (s0) and Polysaccharide Anti- Pneumococcal Vaccine (s4) Compared to Polysaccharide Anti- Pneumococcal Vaccine Alone (s4) In Patients With Common Variable Immunodeficiency
|
Phase 2 | |
| Completed |
NCT03513328 -
Conditioning Regimen for Allogeneic Hematopoietic Stem-Cell Transplantation
|
Phase 1/Phase 2 | |
| Completed |
NCT03188419 -
Breadth of Donor Options for People With Inherited Diseases Requiring Allogeneic Hematopoietic Stem Cell Transplant in the Era of Alternative Donor Transplants Using Post-Transplantation Cyclophosphamide
|
||
| Not yet recruiting |
NCT05481554 -
Composition and Function of Gut Microbiota in Porto-sinusoidal Vascular Disease Associated With Variable Common Immunodeficiency
|