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

August 22, 2021 updated by: Baxalta now part of Shire

A Clinical Investigation to Assess the Safety and Efficacy of Immune Globulin Intravenous (Human), 10% in Subjects With Primary Immunodeficiency Disorders

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Children´s Hospital Los Angeles
      • Stanford, California, United States, 94304-8786
        • Stanford University Medical Center
    • Colorado
      • Englewood, Colorado, United States, 80112
        • 1st Allergy and Clinical Research Center
    • Florida
      • North Palm Beach, Florida, United States, 33408
        • Allergy Associates of the Palm Beaches
      • Tampa, Florida, United States, 33613
        • University of South Florida; Asthma, Allergy & Immunology CRU
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - St. Lukes Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children´s Hospital Boston
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Allergy, Asthma & Immunology Assoc.
      • Papillion, Nebraska, United States, 68046
        • Asthma and Allergy Center
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center, Albert Einstein College of Medicine
    • Texas
      • Dallas, Texas, United States, 75230
        • Pediatric Allergy/Immunology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean number of acute serious bacterial infections per participant per year
Time Frame: Throughout the study period of 18 months
Throughout the study period of 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxalta now part of Shire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2002

Primary Completion (Actual)

December 16, 2003

Study Completion (Actual)

December 16, 2003

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 10, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

August 24, 2021

Last Update Submitted That Met QC Criteria

August 22, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 160101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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