Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections

December 29, 2006 updated by: The Center for Rheumatic Disease, Allergy, & Immunology
  • This is the first study, that we are aware of, that will evaluate the efficacy of IgIV in patients with IgG subclass deficiency.
  • Will provide data for further collaboration in extending study to involve other immunological centers in the United States to study patients with similar disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

*10 consenting adults (18 or older) will receive IgIV (Gamunex 10%) monthly at a dose of 400mg/kg body weight IV at 3ml/minute. Comprehensive labs will be monitored at each visit, as well as clinical eval, plus patients will complete a questionnaire each time. There is also a 3 month follow-up visit after completion of therapy. Specific xrays will be done at the beginning and with the last treatment.

Study Type

Interventional

Enrollment

10

Phase

  • Phase 2

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
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Center for Rheumatic Disease, Allergy, Immunology

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult (18 or older) with deficiency in one or more IgG subclasses with documented history of recurrent infections limited to upper or lower respiratory tract, urinary, and/or skin.

Exclusion Criteria:

  • Patients with panhypogammaglobulinemia or selective IgA deficiency.

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Lab values ck'ed baseline and with each treatment, and 15 mo. visit
Xray of Chest and sinus baseline and on 12th and last treatment
Clinical assessment baseline, every treatment, and 15 mo.

Secondary Outcome Measures

Outcome Measure
Patient questionnaires completed by patients, baseline, prior to each treatment, and at 15 month vist.

Collaborators and Investigators

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

Sponsor

The Center for Rheumatic Disease, Allergy, & Immunology

Collaborators

Grifols Therapeutics LLC

Investigators

  • Principal Investigator: Nabih I Abdou, MD, PhD, Center for Rheumatic Disease, Allergy, Immunology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2004

Study Completion

December 1, 2006

Study Registration Dates

First Submitted

December 28, 2006

First Submitted That Met QC Criteria

December 29, 2006

First Posted (ESTIMATE)

January 1, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

January 1, 2007

Last Update Submitted That Met QC Criteria

December 29, 2006

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-489

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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