NCT00417573

Brief Summary

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 1, 2007

Completed
Last Updated

January 1, 2007

Status Verified

December 1, 2006

First QC Date

December 28, 2006

Last Update Submit

December 29, 2006

Conditions

IgG DeficiencyInfections

Keywords

ImmunodeficiencyGammaglobulinIgG subclass deficiency with recurrent infections

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

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

Interventions

IV Gamunex 10%DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with panhypogammaglobulinemia or selective IgA deficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Rheumatic Disease, Allergy, Immunology

Kansas City, Missouri, 64111, United States

Location

Related Publications (1)

  • Abdou NI, Greenwell CA, Mehta R, Narra M, Hester JD, Halsey JF. Efficacy of intravenous gammaglobulin for immunoglobulin G subclass and/or antibody deficiency in adults. Int Arch Allergy Immunol. 2009;149(3):267-74. doi: 10.1159/000199723. Epub 2009 Feb 12.

    PMID: 19218820DERIVED

MeSH Terms

Conditions

IgG DeficiencyInfectionsImmunologic Deficiency Syndromes

Condition Hierarchy (Ancestors)

DysgammaglobulinemiaBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesImmune System Diseases

Study Officials

  • Nabih I Abdou, MD, PhD

    Center for Rheumatic Disease, Allergy, Immunology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 28, 2006

First Posted

January 1, 2007

Study Start

December 1, 2004

Study Completion

December 1, 2006

Last Updated

January 1, 2007

Record last verified: 2006-12

Locations

US(1)