Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-25

Study Completion Date

2003-12-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to assess the safety and efficacy of Immune Globulin Intravenous (Human), 10% (IGIV 10%) in subjects with primary immunodeficiency disorders.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID)

NCT04346108

Primary Immunodeficiency Diseases (PID)

COMPLETED PHASE3

An Open Phase 3 Study of IV-Globulin SN Inj.10% to Treat Immune Thrombocytopenia

NCT02063789

Immune Thrombocytopenia

COMPLETED PHASE3

Efficacy and Safety of IVIG-L in ITP Patients

NCT00151840

Purpura, Thrombocytopenic, Idiopathic

COMPLETED PHASE3

Rapid Infusion Of Immune Globulin Intravenous (IGIV) In Patients With ITP

NCT00220727

Purpura, Thrombocytopenic, Idiopathic

COMPLETED PHASE2

Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura

NCT00162006

Immune Thrombocytopenic Purpura (ITP)

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Immunodeficiency Diseases (PID) Immune Thrombocytopenic Purpura (ITP) Kawasaki Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Immune Globulin Intravenous (Human), 10%

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to any study-related procedures and study product administration
* Diagnosis of a PID disorder as defined by World Health Organization criteria for which the subject has been receiving a regimen of IGIV infusions every 21 to 28 days over a period of at least 4 months pre-study at a dose of 300-600 mg/kg body weight
* Subjects \> 24 months of age
* A negative serum pregnancy test for any female subject who is of childbearing potential.

Exclusion Criteria

* Subjects sero-positive at enrollment for one or more of the following: hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus (HCV), antibodies to human immunodeficiency virus (HIV) Types 1 or 2
* Subjects with levels of alanine amino transferase (ALT) and aspartate amino transferase (AST) \> 2.5 times the upper limit of normal for the testing laboratory. An AST \> 2.5 times the upper limit of normal is allowable, if the ALT does not exceed the upper limit of the reference range for the testing laboratory
* Subjects with neutropenia (defined as an ANC \>= 1,000/mm3)
* Subjects with serum creatinine levels greater than two times the upper limit of normal for age and gender
* Subjects with malignancy or a history of malignancy
* Subjects who received any blood or blood product exposure other than an IGIV and/or immune serum globulin (ISG) preparation within the 6 months prior to study entry
* Subjects with an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV and/or ISG infusions
* Subjects with selective complete IgA deficiency
* Subjects with moderate levels of anti-IgA antibodies (\>150), or subjects with lower anti-IgA antibodies who are naive to IGIV treatment. (Subjects with lower levels of IgA antibodies, whom the investigators know to have tolerated IgA containing IGIV preparations in the past, may be included if the investigator is comfortable with this)
* Subjects receiving antibiotic therapy for the treatment of infection within 30 days prior to enrollment
* Subjects who receive prophylactic antibiotics as part of their care regimen
* Subjects participating in another clinical study involving an investigational product or device within 30 days prior to study entry

Minimum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No