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

Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00417573
• Other study ID #: 04-489
• Status: Completed
• Phase: Phase 2
• First received: December 28, 2006
• Last updated: December 29, 2006
• Start date: December 2004
• Est. completion date: December 2006

Study information

• Verified date: December 2006
• Source: The Center for Rheumatic Disease, Allergy, & Immunology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• IgG Deficiency
• Infection
• Infections

Intervention

Drug:
• IV Gamunex 10%

Locations

Country	Name	City	State
United States	Center for Rheumatic Disease, Allergy, Immunology	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
The Center for Rheumatic Disease, Allergy, & Immunology	Grifols Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lab values ck'ed baseline and with each treatment, and 15 mo. visit
Primary	Xray of Chest and sinus baseline and on 12th and last treatment
Primary	Clinical assessment baseline, every treatment, and 15 mo.
Secondary	Patient questionnaires completed by patients, baseline, prior to each treatment, and at 15 month vist.