Hypogammaglobulinemia Clinical Trial
Official title:
A Pilot Study to Assess Tolerability of Subcutaneous Immunoglobulin Treatment (Hizentra) in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation
Tolerability of home subcutaneous immunoglobulin (ScIG) for replacement therapy for hypogammaglobulinemia in allogeneic HCT patients. A financial analysis comparing the cost of ScIG with intravenous immunoglobulin (IVIG) will also be performed.
The purpose of the study is to determine whether home subcutaneous immunoglobulin (ScIG) is tolerated as replacement therapy for hypogammaglobulinemia in patients that have undergone allogeneic hematopoietic cell transplantation (alloHCT). Secondary objective is to perform a financial analysis comparing the cost of ScIG with intravenous immunoglobulin (IVIG). The study hypothesis is that home based SCIG treatment is applicable and tolerated well for replacement treatment in alloHCT patients. This will be examined in two sets of patients recruited: A) Patients already on IVIG replacement therapy and B) Newly diagnosed patients with hypogammaglobulinemia. Economic analysis will be performed by comparing the cost with an equal number of patients retrospectively determined to have undergone treatment with IVIG. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04502030 -
Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients With Chronic Lymphocytic Leukemia ("PRO-SID" Study)
|
Phase 3 | |
| Completed |
NCT02231879 -
Plerixafor Versus G-CSF in the Treatment of People With WHIM Syndrome
|
Phase 2/Phase 3 | |
| Recruiting |
NCT05678621 -
Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Immunoglobulin Stopping or Extension
|
Phase 2/Phase 3 | |
| Completed |
NCT01581593 -
Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)
|
Phase 3 | |
| Completed |
NCT02043379 -
Intravenous Immunoglobulin for Early Prevention of Cardiopulmonary Bypass Induced Hypogammaglobulinemia in Infants and Neonates
|
N/A | |
| Completed |
NCT00138697 -
Kinetics, Efficacy and Safety of IVIG-L in Hypogammaglobulinemia Patients
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT04447937 -
Immunodeficiency in MS
|
||
| Completed |
NCT00115778 -
Intravenous Immunoglobulin (IVIG) in Lung Transplantation
|
Phase 2 | |
| Completed |
NCT00161993 -
Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)
|
Phase 2 | |
| Recruiting |
NCT05357781 -
Immunoglobulin Deficiency a Treatable Cause of Fatigue in Patients With Multiple Sclerosis (MS)?
|
||
| Completed |
NCT00278954 -
Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases.
|
Phase 3 | |
| Completed |
NCT00137748 -
Cytomegalovirus Hyperimmune Globulin (CMV-Ig) Replacement in Hypogammaglobulinemic Lung Transplant Recipients
|
Phase 2/Phase 3 | |
| Completed |
NCT01002755 -
Lenalidomide and Ofatumumab in Treating Participants With Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
|
Phase 2 | |
| Recruiting |
NCT04283747 -
Rituximab-Induced Hypogammaglobulinemia in Multiple Sclerosis
|
||
| Recruiting |
NCT05645107 -
A Study to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® Plus Standard Medical Treatment (SMT) Compared to Placebo Plus SMT to Prevent Infections in Participants With Hypogammaglobulinemia and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia
|
Phase 3 | |
| Active, not recruiting |
NCT01981785 -
Investigation of Immune Disorders and Deficiencies
|
N/A | |
| Completed |
NCT02508584 -
Personalized Immunotherapeutic for Antibiotic-resistant Infection
|
Early Phase 1 |