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Primary Immune Deficiency clinical trials

View clinical trials related to Primary Immune Deficiency.

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NCT ID: NCT06014463 Completed - Quality of Life Clinical Trials

Evaluation of Adult Patients With Immunodeficiency Within the Scope of the ICF

Start date: March 15, 2023
Phase:
Study type: Observational

Primary immunodeficiency is a clinically, immunologically, and genetically heterogeneous group of diseases that occur as a result of quantitative and/or qualitative deficiency of one or more cellular and molecular components belonging to the immune system. This classification, called the International Classification of Functioning, Disability and Health ( ICF), constitutes a common language and perspective for the definition of health and health-related conditions. This study aimed to evaluate the body structure function, activity and participation limitations of adult immunodeficiency patients within the scope of ICF and to compare body structure function, activity and participation limitations and compare with healthy people.

NCT ID: NCT04581460 Completed - Clinical trials for Primary Immune Deficiency

Primitive Immunodeficiency and Pregnancy

PREPI
Start date: November 30, 2020
Phase:
Study type: Observational

The management of patients with primary immune deficiency is increasingly codified, however contraception and pregnancy have not yet extensively studied or codified, and the medical monitoring and the prevention of infectious complications thus remains at the discretion of the practitioner. The aim the research is to study the obstetric features and outcome of patients with primary immune defects.

NCT ID: NCT02711228 Completed - Clinical trials for Primary Immune Deficiency

Study of Immune Deficiency Patients Treated With Subcutaneous Immunoglobulin (IgPro20, Hizentra®) on Weekly and Biweekly Schedules

Start date: March 15, 2016
Phase: Phase 4
Study type: Interventional

The purpose of the study is to assess the impact of immunoglobulin treatment by subcutaneous injections every 2 weeks (biweekly) on a cohort of patients with primary and secondary immune deficiencies. The full study will consist of safety, efficacy and Quality of Life (QoL) evaluations and a pharmacokinetic (PK) sub-study. The primary objectives of the study are to determine tolerability and safety of biweekly IgPro20 injection regimen and to compare PK outcomes on weekly and biweekly IgPro20 therapy. Patients who have received and/or are currently receiving immunoglobulin G (IgG) in intravenous (IVIg), or subcutaneous (SCIg) infusions are eligible for inclusion if they meet inclusion/exclusion criteria. The study consists of two parts. In Part 1 of the study enrolled subjects will receive IgPro20 weekly for either 12 weeks (for patients on SCIg infusion prior to the study) or 24 weeks (for patients on IVIg infusion prior to the study). Part 2 will consist of a biweekly treatment with IgPro20 for 52 weeks, for both groups. Additionally, study subjects meeting inclusion criteria for the PK sub-study will undergo a PK sample collection for 1 week and 2 weeks in study Parts 1 and 2, respectively.

NCT ID: NCT01461018 Completed - Clinical trials for Primary Immune Deficiency

Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study)

Start date: October 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the long-term efficacy, tolerability, and safety of IgPro20 in subjects with primary immunodeficiency (PID) as an extension to the preceding follow-up study ZLB07_001CR (NCT01458171).

NCT ID: NCT01199705 Completed - Clinical trials for Primary Immune Deficiency

Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)

Start date: September 2010
Phase: Phase 3
Study type: Interventional

The objective of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics of a subcutaneous immune globulin (SCIG; IgPro20) in subjects with primary immunodeficiency (PID). In addition, the study will assess the health-related quality of life and pharmacoeconomic aspects related to treatment with IgPro20.

NCT ID: NCT01166074 Completed - Clinical trials for Primary Immune Deficiency

Retrospective Chart Review of Subcutaneous IgG Use in Infants

Start date: May 2010
Phase: N/A
Study type: Observational

This study is a retrospective chart review of the use of subcutaneous IgG (SCIG) in infants less than two years old.

NCT ID: NCT00719680 Completed - Clinical trials for Primary Immune Deficiency

Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID)

Start date: June 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether a long-term use of a new human immunoglobulin G with proline (IgPro) is safe and effective in the treatment of primary immunodeficiency.

NCT ID: NCT00680446 Completed - Clinical trials for Primary Immune Deficiency

Safety Study of Subcutaneous Ig NextGen 16% in Patients With Primary Immunodeficiency

Start date: April 2008
Phase: Phase 3
Study type: Interventional

The study aims to assess the safety and tolerability of subcutaneous Ig NextGen 16% in patients with Primary Immune Deficiency who require Immunoglobulin (Ig) G replacement therapy. Ig NextGen 16% is a liquid immunoglobulin (antibody) preparation.

NCT ID: NCT00419341 Completed - Clinical trials for Primary Immune Deficiency

Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy

Start date: November 2006
Phase: Phase 3
Study type: Interventional

The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).