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OpenTrials
Completed

NCT Number: NCT00417573

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

* 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.

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Key information

Conditions

IgG Deficiency Blood Protein Disorders Dysgammaglobulinemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Center for Rheumatic Disease, Allergy, Immunology

Kansas City, Missouri, 64111, United States

About this study

*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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IV Gamunex 10%

Drug

Primary outcomes

  1. Lab values ck'ed baseline and with each treatment, and 15 mo. visit

  2. Xray of Chest and sinus baseline and on 12th and last treatment

  3. 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.

Sponsors and collaborators

Lead sponsor

The Center for Rheumatic Disease, Allergy, & Immunology

Other

Collaborators

  • Grifols Therapeutics LLC

Registry information

Important dates

Study start
2004
Study completion
2006
First posted
Jan 1, 2007
Registry last updated
Jan 1, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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